An interventional study of Liquefied petroleum gas (LPG) cookstove in Infant, Low Birth Weight, sponsored by Emory University. Completed at 4 sites in 4 countries. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Emory University · Not applicable, Interventional, and Prevention
Thompson LM, de Leon O, Sinharoy S, Valdes V, Das S, Aravindalochanan V, Pillarisetti A, Jabbarzadeh S, Balakrishnan K, Diaz-Artiga A, McCracken JP, Rosa G, Th…PubMed 42241937 ↗; 1 more
This study is a randomized controlled trial of liquefied petroleum gas (LPG) stove and fuel distribution in 3,200 households in four countries (India, Guatemala, Peru, and Rwanda). Following a common protocol, each intervention site will recruit 800 pregnant women (aged 18-34 years, 9 - \<20 weeks gestation) and will randomly assign half their households to receive LPG stoves and an 18-month supply of LPG. Control households are anticipated to continue to cook primarily with solid biomass fuels and will receive compensation based on a uniform set of trial-wide principles, customized to each site based on formative research. The mother will be followed along with her child until the child is 1 year old. The researchers estimate that 15% of households will have a second, non-pregnant older adult woman (aged 40 to \<80 years) who will also be enrolled at baseline and followed during the 18-month follow-up period. To optimize intervention use, the researchers will implement behavior change strategies informed by previous experiences and formative research in Year 1. This study will assess cookstove use, conduct repeated personal exposure assessments of household air pollution, and collect dried blood spots and urinary samples for biomarker analysis and biospecimen storage. The primary outcomes are low birth weight, severe pneumonia incidence, and stunting of the child, and systolic blood pressure in the older adult woman. Participants in India, Guatemala and Rwanda will be followed until the child is 5 years old to assess the longer-term effects of the intervention.
Globally, nearly 3 billion people rely on solid fuels for cooking and heating, the vast majority in low- and middle-income countries (LMICs). The resulting household air pollution (HAP) is the third leading risk factor in the 2010 global burden of disease, accounting for an estimated 4.3 million deaths annually, largely among women and young children. Previous interventions have provided cleaner biomass-based cookstoves but have failed to reduce exposure to levels that produce meaningful health improvements. There have been no large-scale field trials with liquefied petroleum gas (LPG) cookstoves, likely the cleanest scalable intervention.
The aim of this study is to conduct a randomized controlled trial of LPG stove and fuel distribution in 3,200 households in four LMICs (India, Guatemala, Peru, and Rwanda) to deliver rigorous evidence regarding potential health benefits across the lifespan. Each intervention site will recruit 800 pregnant women (aged 18-34 years, 9 - \<20 weeks gestation) and will randomly assign half their households to receive LPG stoves and an 18-month supply of LPG. Control households are anticipated to continue to cook primarily with solid biomass fuels and will receive compensation based on a uniform set of trial-wide principles, customized to each site based on formative research. The mother will be followed along with her child until the child is 1 year old. In households with a second, non-pregnant older adult woman (aged 40 to \<80 years) the researchers will also enroll and follow her during the 18-month follow-up period in order to assess cardiopulmonary, metabolic, and cancer outcomes. To optimize intervention use, the researchers will implement behavior change strategies. This study will assess cookstove use, conduct repeated personal exposure assessments to HAP (PM2.5, black carbon, carbon monoxide), and collect dried blood spots and urinary samples for biomarker analysis and biospecimen storage on all participants at multiple time points. The primary outcomes are low birth weight, severe pneumonia incidence, and stunting of the child, and systolic blood pressure in the older adult woman.
This study will address the following specific aims: (1) using an intent-to-treat analysis, determine the effect of a randomized LPG stove and fuel intervention on health in four diverse LMIC populations using a common protocol; (2) determine the exposure-response relationships for HAP and health outcomes; and (3) determine relationships between LPG intervention and both targeted and exploratory biomarkers of exposure/health effects.
This study will provide evidence, including costs and implementation strategies, to inform national and global policies on scaling up LPG stoves among vulnerable populations. Ultimately, this will facilitate deeper policy-level discussions as well as identify requirements for initiating and sustaining HAP interventions globally.
The intervention delivery occurred until the child was one year of age. The researchers will continue to follow participants in India, Guatemala and Rwanda until the child is 5 years old to assess the longer-term effects of the intervention. Previous evidence suggests that the benefits of reduced exposure during the first, critical year of development will continue even if the intervention ends. The researchers will continue using methods employed during the HAPIN trial period. The HAPIN trial provides a unique context in which to address these questions, particularly given the successful intervention and exposure reduction. Participants are well-characterized and health and exposures to air pollution are being documented. Critically, because of its experimental design of the trial, continued follow-up of the cohort will provide rigorous causal inferences about the effects of this 500-day intervention over the most important period of early childhood development.
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Exclusion Criteria for Pregnant Women:
Inclusion Criteria for Older Adult Woman in the Same Household:
Exclusion Criteria for Older Adult Woman in the Same Household:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to the experimental arm will receive a liquefied petroleum gas (LPG) cookstove and 18-month supply of LPG.
Other: Liquefied petroleum gas (LPG) cookstove
Participants in the control group will not receive a liquefied petroleum gas (LPG) stove and will continue using traditional cooking methods (open fire or traditional stoves), or the cooking method of their choice. Control households will receive compensation based on a uniform set of trial-wide principles, customized to each site based on formative research.
The intervention consists of a high-quality locally available liquefied petroleum gas (LPG) stove having at least two burners, a continuous supply of LPG fuel for 18 months, and the promotion of stove use on an exclusive basis for cooking. The intervention will be provided free of charge to all intervention households upon enrollment. On a weekly basis, study staff will examine stove condition, perform any necessary repairs, and measure and record weight of LPG tanks in order to anticipate need for refills.
Birth Weight
Birth weight is assessed by a trained nurse or health worker within 24 hours of birth. Infants are weighed naked or in a pre-weighed blanket. Weight is measured to the nearest 10 g using a digital electronic scale, if performed by the study field staff; otherwise, hospital medical records are used.
Time frame: Within 24 hours of birth (up to 5 months post-randomization of mother)
Incidence of HAPIN Defined Severe Pneumonia
The incidence of severe pneumonia among offspring during the first year of life is assessed as the number of offspring participants presenting at HAPIN health facilities with severe pneumonia. For this study pneumonia criteria are adapted from the WHO classification of childhood pneumonia (2014) and there are 3 algorithms for case criteria: 1) the presence of cough and/or difficult breathing and at least 1 general danger sign plus evidence of pneumonia on lung imaging (i.e., lung ultrasound or chest x-ray), or 2) the presence of cough and/or difficult breathing and hypoxemia (measured either via pulse oximetry (SpO2), or observing a child requiring advanced respiratory support (i.e., intubation and mechanical ventilation, non-invasive ventilation with continuous or bi-level positive airway pressure support, or high-flow nasal cannula oxygen), or 3) children who die prior to evaluation but their death is attributed to pneumonia by verbal autopsy.
Time frame: Up to 12 months after birth
Number of Offspring With Stunting
The primary outcome measured is stunting at one year of age, defined as a length-for-age z-score (LAZ) that is 2 standard deviations below the median of the growth standard. Infant length is assessed at birth and quarterly thereafter, until the child is 12 months old. Z-scores are calculated using the 2006 World Health Organization (WHO) Multi-Growth Reference Standard (MGRS).
Time frame: 12 months after birth
Systolic Blood Pressure Among Older Adult Women
Systolic blood pressure is assessed in the older adult women in the intervention and control arms using automatic sphygmomanometers (Omron HEM-907XL; Osaka, Japan). The study team used the procedures adapted from previously validated methods and cardiovascular outcome studies, following recommendations for the American Heart Association and the European Society of Hypertension. A systolic blood pressure of less than 120 is considered normal for adults. Systolic blood pressure collected at 3, 6, 9, 12, and 18 months post-randomization time points are averaged together for a single post-randomization value.
Time frame: Baseline, Post-randomization (up to 18 months post-randomization)
Child Linear Growth During Extended Follow-up
Linear growth of children is assessed in centimeters of height.
Time frame: 24, 36, 48 and 60 months of age
Caregiver Reported Early Childhood Development Instrument (CREDI) Score During Extended Follow-up
The CREDI is a population-level measure of early childhood development (ECD) for children from 0-3 years of age assessing 4 domains of child development: 1) motor (fine and gross motor), 2) language (expressive and receptive language), 3) cognitive (executive function, problem solving and reasoning, and pre-academic knowledge), and 4) social-emotional (emotional and behavioral self-regulation, emotional knowledge, and social competence). The CREDI long form consists of up to 108 items and the number of questions answered depends on the age of the child. Responses of "yes" are coded as 1 and "no" is coded as 0; certain items are reverse coded. Total raw scores increase by age (with developmental progression), and higher scores indicate increased development. Both domain-specific and overall z-scores are calculated (mean = 0, standard deviation = 1). Z-scores of 0 mean the child has a similar developmental status to the average child. Scores above 0 are higher than the sample reference.
Time frame: 24 months of age
Malawi Developmental Assessment Tool (MDAT) Score
The MDAT measures gross motor (39 items), fine motor (42 items), language/cognition (40 items) and social skills (36 items). Originally developed and validated in rural Malawi, it has now been used in over 25 countries as both a clinical and research tool. The MDAT is a continuous test with start and stop rules. Most items are administered directly to the child and items that are not easily observed (e.g., child speaks in full sentences; child understands sharing with others; child can dress self) are administered by parent report. Children receive either a pass or fail for each item, and summed pass scores can produce a composite score as well as domain-specific scores. Total scores range from 0 to 157 where higher scores indicate greater neurodevelopment. Both domain-specific and overall z-scores are calculated (mean = 0, standard deviation = 1). Z-scores of 0 mean the child has a similar developmental status to the average child. Scores above 0 are higher than the sample reference.
Time frame: 48 and 60 months of age
Maternal Systolic Blood Pressure
Blood pressure is assessed in the pregnant women in the intervention and control arms using automatic sphygmomanometers (OMRON HEM-907XL; Osaka, Japan). The study team will use the procedures adapted from previously validated methods and cardiovascular outcome studies, following recommendations for the American Heart Association and the European Society of Hypertension.
Time frame: Baseline (9-20 weeks gestation), 24-28 and 32-36 weeks gestation
Maternal Diastolic Blood Pressure
Blood pressure is assessed in the pregnant women in the intervention and control arms using automatic sphygmomanometers (OMRON HEM-907XL; Osaka, Japan). The study team will use the procedures adapted from previously validated methods and cardiovascular outcome studies, following recommendations for the American Heart Association and the European Society of Hypertension. Diastolic blood pressure levels of less than 80 are considered normal.
Time frame: Baseline (9-20 weeks gestation), 24-28 and 32-36 weeks gestation
Diastolic Blood Pressure Among Older Adult Women
Diastolic blood pressure is assessed in the older adult women in the intervention and control arms using automatic sphygmomanometers (Omron HEM-907XL; Osaka, Japan). The study team uses the procedures adapted from previously validated methods and cardiovascular outcome studies, following recommendations for the American Heart Association and the European Society of Hypertension. Diastolic blood pressure levels of less than 80 are considered normal. Diastolic blood pressure collected at 3, 6, 9, 12, and 18 months post-randomization time points are averaged together for a single post-randomization value.
Time frame: Baseline, up to 18 months post-randomization
Mean Arterial Pressure
Mean arterial pressure is assessed in the older adult women in the intervention and control arms using automatic sphygmomanometers (Omron HEM-907XL; Osaka, Japan). Mean arterial pressure is calculated as DBP+(SBP-DBP)/3, where SBP=systolic blood pressure and DBP=diastolic blood pressure. Arterial blood pressure collected at 3, 6, 9, 12, and 18 months post-randomization time points are averaged together for a single post-randomization value.
Time frame: Baseline, Up to 18 months post-randomization
Pulse Pressure
Pulse pressure is assessed in the older adult women in the intervention and control arms using automatic sphygmomanometers (Omron HEM-907XL; Osaka, Japan). pressure. Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP). A normal pulse pressure is 40 mmHg and pulse pressure tends to increase above age 50 as arteries stiffen. Pulse pressure collected at 3, 6, 9, 12, and 18 months post-randomization time points are averaged together for a single post-randomization value.
Time frame: Baseline, Up to 18 months post-randomization
Fetal Growth Among Pregnant Women
Pregnant women have ultrasounds during gestation weeks 24-28 and gestation weeks 32-36 to measure fetal growth. Specifically, the researchers evaluated head circumference (HC), abdominal circumference (AC), femur length (FL) and estimated fetal weight (EFW) during gestation. The researchers calculated z-scores for head circumference, abdominal circumference, femur length and estimated fetal weight at the gestational age using World Health Organization (WHO) INTERGROWTH 21st standards. Z-scores have a mean of 0 and a standard deviation of 1. Z-scores over 0 indicate above average measurements, while a negative z-score indicates measurements are lower than average.
Time frame: Gestation Week 24-28 and Gestation Week 32-36
Gestational Age at Birth
Gestational age at birth is measured in weeks, as a continuous outcome, among all live births.
Time frame: Within 24 hours of birth (3-5 months post randomization)
Number of Offspring Born Preterm
Preterm birth is defined as delivery of a living infant prior to 37 completed weeks of gestation.
Time frame: Within 24 hours of birth (3-5 months post randomization)
Number of Offspring With WHO Defined Non-severe Pneumonia
Cumulative incidence of WHO non-severe pneumonia (2014 definition and 2013 definition) during the first year of life. Cases of pneumonia are recorded whenever children present to HAPIN health facilities with respiratory symptoms.
Time frame: Up to 12 months after birth
Number of Offspring With WHO Defined Severe Pneumonia
Cumulative incidence of WHO non-severe pneumonia (2014 definition and 2013 definition) during the first year of life. Cases of pneumonia are recorded whenever children present to HAPIN health facilities with respiratory symptoms.
Time frame: Up to 12 months after birth
Number of Offspring Hospitalized for Respiratory Illness
Cumulative incidence of hospitalizations for a respiratory illness during the first year of life.
Time frame: Up to 12 months after birth
Number of Offspring With WHO Pocket Book Non-severe Pneumonia
Cumulative incidence of WHO non-severe pneumonia during the first year of life, as defined in the second edition of the "Pocket book of hospital care for children" (2013). Cases of pneumonia are recorded whenever children present to HAPIN health facilities with respiratory symptoms.
Time frame: Up to 12 months after birth
Number of Offspring With WHO Pocket Book Severe Pneumonia
Cumulative incidence of WHO severe pneumonia during the first year of life, as defined in the second edition of the "Pocket book of hospital care for children" (2013). Cases of pneumonia are recorded whenever children present to HAPIN health facilities with respiratory symptoms.
Time frame: Up to 12 months after birth
Number of Offspring With Hypoxemic Pneumonia
Cumulative incidence of hypoxemic pneumonia during the first year of life. Cases of pneumonia are recorded whenever children present to HAPIN health facilities with respiratory symptoms.
Time frame: Up to 12 months after birth
Number of Offspring With Ultrasound or Radiograph Pneumonia
Cumulative incidence of lung ultrasound or chest radiograph pneumonia during the first year of life. Cases of pneumonia are recorded whenever children present to HAPIN health facilities with respiratory symptoms.
Time frame: Up to 12 months after birth
Brachial Artery Reactivity Testing (BART)
Brachial artery reactivity testing (BART) measures endothelial function via flow-mediated dilation (FMD) in response to reactive hyperemia following release of arm blood-flow occlusion. Using ultrasound, the brachial artery is first imaged at rest to establish the baseline (pre-occlusion) diameter. A blood pressure cuff is then inflated to induce distal arm ischemia for 5 minutes. Upon cuff release, the resulting surge in blood flow (reactive hyperemia) stimulates the artery to dilate; the artery is imaged repeatedly during this period and the maximum post-occlusion diameter is identified. The outcome, FMD, is expressed as the maximum percent change in diameter relative to baseline: FMD% = (maximum post-occlusion diameter - baseline diameter) ÷ baseline diameter × 100. Higher values indicate greater dilation and better endothelial function; lower values indicate worse endothelial function.
Time frame: Baseline, 18 months post-randomization
Carotid Intima-media Thickness (CIMT) Among Older Adult Women
The carotid intima-media thickness test (CIMT) is used to determine the extent of carotid atherosclerotic vascular disease. The test measures the thickness of the inner two layers (intima and media) of the carotid artery and can detect plaque build-up prior to physical symptoms being experienced. The carotid ultrasound will be performed with a portable ultrasound by trained sonographers. CIMT is a well-established imaging biomarker of atherosclerosis, where higher values indicate greater carotid arterial wall thickness and have been associated with higher cardiovascular disease risk.
Time frame: Baseline, 18 months post-randomization
St. George Respiratory Questionnaire (SGRQ) Score
Adult respiratory health and well-being is assessed with the St. George Respiratory Questionnaire (SGRQ). The SGRQ measures impaired health and perceived well-being among individuals with chronic airway disease. The SGRQ has sections assessing symptoms, activities that cause breathlessness or are limited because of breathlessness, and the impacts of respiratory problems on employment, sense of control of health, panic, stigmatization, medication use, side effects of therapies, expectations for health and disturbances of daily life. The questionnaire includes multiple choice, true/false and open-ended questions.
Time frame: Baseline, 18 months post-randomization
Short Form 36 Survey (SF-36) Score Among Older Adult Women
The Short Form 36 survey (SF-36) is a standardized, preference-based 36 item questionnaire evaluating quality of life. The survey has 8 sections (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health). Possible scores range from 0 (lowest quality of life) to 100 (highest quality of life).
Time frame: Baseline, 18 months post-randomization
Child Linear Growth Assessed as Length-for-Age Z-Scores
Linear growth of children is assessed in centimeters at birth and quarterly thereafter, until the child is 12 months old. Infant recumbent length was converted to a length-for-age z-score (LAZ) using the WHO Child Growth Standards. Z-scores have a mean of 0 and a standard deviation of 1. Z-scores above 0 indicate above average length-for-age, while a negative z-score indicates lower than average length-for-age.
Time frame: Birth (3-5 months post-randomization), 3, 6, 9 and 12 months of age
Caregiver Reported Early Childhood Development Instrument (CREDI) Score
The Caregiver Reported Early Childhood Development Instrument (CREDI) is a population-level measure of early childhood development (ECD) for children from 0-3 years of age. The CREDI assesses 4 domains of child development: 1) motor (fine and gross motor), 2) language (expressive and receptive language), 3) cognitive (executive function, problem solving and reasoning, and pre-academic knowledge), and 4) socio-emotional (emotional and behavioral self-regulation, emotional knowledge, and social competence). The CREDI long form consists of up to 108 items and the number of questions answered depends on the age of the child. Responses of "yes" are coded as 1 while responses of "no" are coded as 0; certain items are reverse coded. Norm-referenced, age standardized z-scores for overall and domain-specific CREDI scores were calculated. Z-scores have a mean of 0 and standard deviation of 1; values below 0 indicate ECD scores lower than the global CREDI norm-referenced population.
Time frame: 12 months of age
Height
Height is measured in meters. Height in new mothers in Rwanda is measured when the child is 24 months old. For new mothers in Guatemala height is measured when the child is 24 and 36 months old. In older adult women, height is measured when the child is 24-months old.
Time frame: 24 and 36 months of age of the child
Weight
Weight is measured in kilograms (kg). Weight in new mothers in Rwanda is measured when the child is 24 months old. For new mothers in Guatemala weight is measured when the child is 24 and 36 months old. In older adult women, weight is measured when the child is 24 months old. Weight is measured in children at 24, 36, 48 and 60 months of age.
Time frame: 24, 36, 48 and 60 months of age of the child
Body Mass Index (BMI)
BMI is calculated as weight in kilograms divided by height in meters (m) squared (kg/m\^2). BMI in new mothers in Rwanda is calculated from height and weight measurements obtained when the child is 24 months old. For new mothers in Guatemala BMI is calculated from height and weight measurements obtained when the child is 24 and 36 months old. In older adult women, BMI is calculated from height and weight measurements obtained when the child is 24 months old.
Time frame: 24, 36, 48 and 60 months of age of the child
Child Blood Pressure
Blood pressure is assessed in the children using automatic sphygmomanometers (OMRON HEM-907XL; Osaka, Japan). The study team uses the procedures adapted from previously validated methods and cardiovascular outcome studies, following recommendations for the American Heart Association and the European Society of Hypertension.
Time frame: 24 (Rwanda only) and 60 months of age
Diastolic Blood Pressure in New Mothers
Blood pressure is assessed in the new mothers in the intervention and control arms using automatic sphygmomanometers (OMRON HEM-907XL; Osaka, Japan). The study team will use the procedures adapted from previously validated methods and cardiovascular outcome studies, following recommendations for the American Heart Association and the European Society of Hypertension.
Time frame: 9, 12, and 18 months post-randomization
Systolic Blood Pressure in New Mothers
Blood pressure is assessed in the new mothers in the intervention and control arms using automatic sphygmomanometers (OMRON HEM-907XL; Osaka, Japan). The study team will use the procedures adapted from previously validated methods and cardiovascular outcome studies, following recommendations for the American Heart Association and the European Society of Hypertension.
Time frame: 9, 12, and 18 months post-randomization
Change in Fine Particulate Matter (PM2.5) Exposure
Personal monitoring equipment is used to assess exposure to fine particulate matter (PM2.5) over a 24-hour period in intervention and control participants (pregnant women, older adult women, and children). Exposure for pregnant women is measured at baseline, 24-28 weeks gestation, 32-36 weeks gestation, and in Guatemala and India, when the child is 24 months old. Exposure for the child is measured at 3, 6, 12, 24, 36, 48 and 60 months of age. Exposure for the older adult women is measured at baseline, 3, 6, 12 and 18 months post-randomization, and in Guatemala and India, when the child is 24 months old.
Time frame: Baseline, 3, 6, 9, 12 and 18 months post-randomization, and at 24, 36, 48, 60 months of age of the child
Change in Carbon Monoxide (CO) Exposure
Personal monitoring equipment is used to assess exposure to carbon monoxide (CO) over a 24-hour period in intervention and control participants (pregnant women, older adult women, and children). Exposure for pregnant women is measured at baseline, 24-28 weeks gestation, 32-36 weeks gestation, and in Guatemala and India, when the child is 24 months old. Exposure for the child is measured at 3, 6, 12, 24, 36, 48 and 60 months of age. Exposure for the older adult women is measured at baseline, 3, 6, 12 and 18 months post-randomization, and in Guatemala and India, when the child is 24 months old.
Time frame: Baseline, 3, 6, 9, 12 and 18 months post-randomization, and at 24, 36, 48, 60 months of age of the child
Change in Black Carbon (BC) Exposure
Personal monitoring equipment is used to assess exposure to black carbon (BC) over a 24-hour period in intervention and control participants (pregnant women, older adult women, and children). Exposure for pregnant women is measured at baseline, 24-28 weeks gestation, 32-36 weeks gestation, and in Guatemala and India, when the child is 24 months old. Exposure for the child is measured at 3, 6, 12, 24, 36, 48 and 60 months of age. Exposure for the older adult women is measured at baseline, 3, 6, 12 and 18 months post-randomization, and in Guatemala and India, when the child is 24 months old.
Time frame: Baseline, 3, 6, 9, 12 and 18 months post-randomization, and at 24, 36, 48, 60 months of age of the child
Maternal Perceived Stress Scale (PSS)
The 10-item Cohen's Perceived Stress Scale (PPS) assesses the way an individual appraises their life events as stressful (e.g., "In the last month, how often have you felt difficulties were piling up so high that you could not overcome them?") (Cohen, 1983). Likert-level responses ranged from 0 (never) to 4 (very often), meaning a high PPS score would result in a high level of perceived stress. A Spanish language PPS created and tested and found to be valid and reliable (Vallijo et al., 2018).
Time frame: 9 to 18 months post-randomization (3 to 12 months of age of the child)
Spontaneous Abortion
Fetal death before 19 weeks 6 days.
Time frame: Baseline through 20 weeks gestation
Early Preterm Birth
Births at less than 34 weeks completed gestation, among all live births.
Time frame: Birth
Preterm Delivery
Including preterm birth and stillbirth.
Time frame: Birth
Stillbirth
Any fetal deaths occurring at or after 20 weeks' gestation OR indicated on Serious Adverse Event form OR on Pregnant Woman Medical History form OR on verbal autopsy form.
Time frame: Up to birth
Neonatal Death
Death between birth and 28 days.
Time frame: Birth through 28 days
Messenger Ribonucleic Acid (mRNA) Expression and microRNA in Older Adult Women
Two buccal cell scrapes will be collected by gently scraping the buccal mucosa on both sides of the mouth with a small plastic collection spoon. Nasal turbinate brush samples can be collected using a soft cytobrush on each turbinate. Collection is gentle and causes no discomfort to study participants. Both samples will be processed in the laboratory according to procedures detailed in the protocol. This will occur in the older adult women in an NCI substudy.
Time frame: Baseline, 18 months post-randomization
Microbiome Operational Taxonomic Units (OTUs) in Older Adult Women
For the oral rinse, participants will vigorously rinse their mouth and the rinsates are collected in a centrifuge tube. The tube is centrifuged and the pellet and supernatant are removed to separate cryovials, labeled and frozen. This will occur in the older adult women in an NCI substudy.
Time frame: Baseline, 18 months post-randomization
Epigenetics (DNA Methylation) in Older Adult Women
Two buccal cell scrapes will be collected by gently scraping the buccal mucosa on both sides of the mouth with a small plastic collection spoon. A 5-mL venous blood sample will be collected in an ethylenediaminetetraacetic acid (EDTA) vacutainer tube by standard clinical venipuncture of a cubital vein. Both samples will be transported and processed in the laboratory according to procedures detailed in the protocol. This will occur in the older adult women in an NCI substudy.
Time frame: Baseline, 18 months post-randomization
Metabolomics and MicroRNA in Older Adult Women
A 5-mL venous blood sample will be collected in an EDTA vacutainer tube by standard clinical venipuncture of a cubital vein. The sample will be transported and processed in the laboratory according to procedures detailed in the protocol. This will occur in the older adult women in an NCI substudy.
Time frame: Baseline, 18 months post-randomization
Household Food Insecurity
Household food insecurity will be measured using the Food Insecurity Experience Scale (FIES), developed and validated by the Food and Agriculture Organization (FAO). The FIES module includes eight questions, each with yes/no response options, on the household's access to adequate food, and is intended to measure three domains of food insecurity: uncertainty/anxiety, food quantity, and food quality. Each question takes values of 0/1, which are summed for a possible total score of 0-8.
Time frame: Baseline, 18 months post-randomization
Dietary Diversity - Women
Dietary diversity for women will be measured using the Minimum Dietary Diversity - Women (MDD-W) questionnaire from the FAO and FHI 360, which uses an open recall format to collect data on foods and beverages consumed by the respondent during the previous day and night. Responses will be categorized into ten food groups and women who report consuming five or more out of ten food groups will be categorized as achieving minimum dietary diversity.
Time frame: Baseline to 18 months post-randomization
Dietary Diversity - Infants
Minimum dietary diversity for children will be measured using the World Health Organization (WHO) infant and young child feeding questionnaire. The questionnaire uses a combination of open and closed recall and asks caregivers to report on foods and beverages consumed by the infant or young child during the previous day and night. Responses will be categorized into eight food groups and infants who consumed five or more out of ten eight food groups will be categorized as achieving minimum dietary diversity.
Time frame: 9, 12, 15 and 18 months post-randomization (3, 6, 9, and 12 months of age)
Hemoglobin (Hb) Concentration / Anemia - Women
Hb will be measured from a single drop of capillary blood obtained via finger prick, using the HemoCue® Hb 201system (HemoCue® AB) point-of-care device
Time frame: Baseline, 3 and 5 months post-randomization
Hemoglobin (Hb) Concentration / Anemia - Infants
Hb will be measured from a single drop of capillary blood obtained via finger prick, using the HemoCue® Hb 201system (HemoCue® AB) point-of-care device
Time frame: 12 and 18 months post-randomization (6 and 12 months of age)
Child Lung Function
Lung function measurements will be made using the forced oscillation technique (FOT) with the Tremoflo C-100 device with disposable mouthpieces. FOT is a technique that can identify early changes in the airways. The FOT device measures the relationship between externally applied pressure waves and the resulting air flow to measure respiratory impedance. Values produced at high frequencies correspond to the proximal and large airways, and values produced at low frequencies correspond to distal and small airways. This measurement will be conducted in children in Guatemala.
Time frame: 36, 48 and 60 months of age
Carotid Intima-media Thickness (CIMT) Among Older Adult Women During Extended Follow-up
The carotid intima-media thickness test (CIMT) is used to determine the extent of carotid atherosclerotic vascular disease. The test measures the thickness of the inner two layers of the carotid artery and can detect plaque build up prior to physical symptoms being experienced. The carotid ultrasound will be performed with a portable ultrasound by trained sonographers. This outcome is only assessed in Guatemala during the extended follow-up period (after the birth of the household child).
Time frame: 24 months of age of the child
Change in Urinary Biomarkers
Multiple exposure biomarkers will be measured: 3-OH Cotinine, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), levoglucosan, 8OH-deoxyguanosine (8OHdG), and Volatile Organic Chemicals (VOC) metabolites. Exposure biomarkers (especially for children whose urine may be limited) will be prioritized as follows: polycyclic aromatic hydrocarbon (PAH) biomarkers, levoglucosan, volatile organic chemicals (VOC) biomarkers, heavy metals, and tobacco-related biomarkers. Urinary biomarkers will be measured in pregnant women at baseline, 24-28 weeks gestation, and 32-36 weeks gestation, and in new mothers when the child is 24-months old. Biomarkers will be measured in older adult women at baseline, 3, 6, 9, 12 and 18 months post-randomization. Biomarkers will be measured in children at 3, 6, 12 and 24 months of age.
Time frame: Baseline, 3, 6, 9, 12 and 18 months post-randomization, and 24 months of age of the child
Change in Dried Blood Spot (DBS) Biomarkers
The main biomarkers to be measured from the dried blood spots is: inflammation markers, endothelial markers of cardiovascular disease, oxidative stress markers, Hb, HbA1C, tumor-associated antigen antibodies, cytochrome P450, p53 tumor-associated antigen (TAA), lipids, metabolomics, MiRNA, heavy metals. DBS biomarkers will be measured in pregnant women at baseline, 24-28 weeks gestation, and 32-36 weeks gestation, and in new mothers when the child is 24-months old. DBS biomarkers will be measured in older adult women at baseline, 3, 6, 9, 12 and 18 months post-randomization. DBS biomarkers will be measured in children at 3, 6, 12 and 24 months of age.
Time frame: Baseline, 3, 6, 9, 12 and 18 months post-randomization, and at 24 months of age of the child
Reported Diarrhea in Children
Reported diarrhea will be extracted from the Monthly Child Health Status Visit case report form. Each month, the child's caretaker will be administered a survey to obtain information on whether the child under 1 year of age (the HAPIN study index child) or any other child in the home under 5 has experienced WHO-defined diarrhea (defined as three or more loose stools that can take the shape of a container within a 24-hour period) in the past 7 days. Persistent diarrhea will be defined as 14 or more continuous days of diarrhea. The presence of blood in the stool will also be noted as an indicator of severity.
Time frame: Up to 12 months after birth
Participant enrollment began May 7, 2018 and all follow up was complete by June 30, 2025. Participants were enrolled India, Guatemala, Peru, and Rwanda.
| Milestone | Liquefied Petroleum Gas Cookstove - Pregnant Women | Liquefied Petroleum Gas Cookstove - Offspring of Pregnant Women | Liquefied Petroleum Gas Cookstove - Older Adult Women in Household of Pregnant Women | Control - Pregnant Women | Control - Offspring of Pregnant Women | Control - Older Adult Women in Household of Pregnant Women |
|---|---|---|---|---|---|---|
| Started | 1593 | 1536 | 217 | 1607 | 1525 | 226 |
| Completed | 1480 | 1480 | 184 | 1469 | 1469 | 177 |
| Not completed | 113 | 56 | 33 | 138 | 56 | 49 |
| Withdrew: Determined to be ineligible after randomization | 3 | 0 | 1 | 2 | 0 | 1 |
| Withdrew: Withdrawal by subject | 14 | 9 | 22 | 43 | 8 | 33 |
| Withdrew: Withdrawn by study team | 3 | 1 | 0 | 2 | 0 | 2 |
| Withdrew: Moved away from area | 28 | 17 | 4 | 21 | 10 | 2 |
| Withdrew: Loss of pregnancy | 36 | 0 | 0 | 31 | 0 | 0 |
| Withdrew: Death | 0 | 28 | 1 | 1 | 36 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 | 1 | 1 | 4 |
| Withdrew: Infant of pregnant participant died after birth | 28 | 0 | 0 | 36 | 0 | 0 |
| Withdrew: Had other reason | 1 | 1 | 4 | 1 | 1 | 7 |
| Milestone | Liquefied Petroleum Gas Cookstove - Pregnant Women | Liquefied Petroleum Gas Cookstove - Offspring of Pregnant Women | Liquefied Petroleum Gas Cookstove - Older Adult Women in Household of Pregnant Women | Control - Pregnant Women | Control - Offspring of Pregnant Women | Control - Older Adult Women in Household of Pregnant Women |
|---|---|---|---|---|---|---|
| Started | 1071 | 1071 | 106 | 1101 | 1101 | 102 |
| Completed 24-month visit | 880 | 947 | 106 | 967 | 967 | 102 |
| Completed 36-month visit | 947 | 880 | 5 | 913 | 913 | 4 |
| Completed 48-month visit | 1014 | 1014 | 0 | 1050 | 1050 | 0 |
| Completed | 1003 | 1003 | 0 | 1038 | 1038 | 0 |
| Not completed | 68 | 68 | 106 | 63 | 63 | 102 |
Birth weight is assessed by a trained nurse or health worker within 24 hours of birth. Infants are weighed naked or in a pre-weighed blanket. Weight is measured to the nearest 10 g using a digital electronic scale, if performed by the study field staff; otherwise, hospital medical records are used.
| grams | Liquefied Petroleum Gas Cookstove - Offspring of Pregnant Women | Control - Offspring of Pregnant Women |
|---|---|---|
| Birth Weight | 2921 ± 474.3 | 2898 ± 467.9 |
The incidence of severe pneumonia among offspring during the first year of life is assessed as the number of offspring participants presenting at HAPIN health facilities with severe pneumonia. For this study pneumonia criteria are adapted from the WHO classification of childhood pneumonia (2014) and there are 3 algorithms for case criteria: 1) the presence of cough and/or difficult breathing and at least 1 general danger sign plus evidence of pneumonia on lung imaging (i.e., lung ultrasound or chest x-ray), or 2) the presence of cough and/or difficult breathing and hypoxemia (measured either via pulse oximetry (SpO2), or observing a child requiring advanced respiratory support (i.e., intubation and mechanical ventilation, non-invasive ventilation with continuous or bi-level positive airway pressure support, or high-flow nasal cannula oxygen), or 3) children who die prior to evaluation but their death is attributed to pneumonia by verbal autopsy.
| Participants | Liquefied Petroleum Gas Cookstove - Offspring of Pregnant Women | Control - Offspring of Pregnant Women |
|---|---|---|
| Incidence of HAPIN Defined Severe Pneumonia | 85 | 90 |
The primary outcome measured is stunting at one year of age, defined as a length-for-age z-score (LAZ) that is 2 standard deviations below the median of the growth standard. Infant length is assessed at birth and quarterly thereafter, until the child is 12 months old. Z-scores are calculated using the 2006 World Health Organization (WHO) Multi-Growth Reference Standard (MGRS).
| Participants | Liquefied Petroleum Gas Cookstove - Offspring of Pregnant Women | Control - Offspring of Pregnant Women |
|---|---|---|
| Number of Offspring With Stunting | 321 | 299 |
Systolic blood pressure is assessed in the older adult women in the intervention and control arms using automatic sphygmomanometers (Omron HEM-907XL; Osaka, Japan). The study team used the procedures adapted from previously validated methods and cardiovascular outcome studies, following recommendations for the American Heart Association and the European Society of Hypertension. A systolic blood pressure of less than 120 is considered normal for adults. Systolic blood pressure collected at 3, 6, 9, 12, and 18 months post-randomization time points are averaged together for a single post-randomization value.
| millimeters of mercury (mmHg) | Liquefied Petroleum Gas Cookstove - Older Adult Women in Household of Pregnant Women | Control - Older Adult Women in Household of Pregnant Women |
|---|---|---|
| Baseline | 114.5 ± 15.2 | 114.4 ± 15.1 |
| Post-randomization | 111.5 ± 13.2 | 111.9 ± 12.5 |
Linear growth of children is assessed in centimeters of height.
| centimeters (cm) | Liquefied Petroleum Gas Cookstove - Offspring of Pregnant Women | Control - Offspring of Pregnant Women |
|---|---|---|
| 24 months of age | 81.43 ± 3.69 | 81.47 ± 3.71 |
| 36 months of age | 89.25 ± 3.80 | 89.34 ± 3.86 |
| 48 months of age | 96.13 ± 4.21 | 96.24 ± 4.24 |
| 60 months of age | 102.83 ± 4.41 | 102.82 ± 4.48 |
The CREDI is a population-level measure of early childhood development (ECD) for children from 0-3 years of age assessing 4 domains of child development: 1) motor (fine and gross motor), 2) language (expressive and receptive language), 3) cognitive (executive function, problem solving and reasoning, and pre-academic knowledge), and 4) social-emotional (emotional and behavioral self-regulation, emotional knowledge, and social competence). The CREDI long form consists of up to 108 items and the number of questions answered depends on the age of the child. Responses of "yes" are coded as 1 and "no" is coded as 0; certain items are reverse coded. Total raw scores increase by age (with developmental progression), and higher scores indicate increased development. Both domain-specific and overall z-scores are calculated (mean = 0, standard deviation = 1). Z-scores of 0 mean the child has a similar developmental status to the average child. Scores above 0 are higher than the sample reference.
| z-score | Liquefied Petroleum Gas Cookstove - Offspring of Pregnant Women | Control - Offspring of Pregnant Women |
|---|---|---|
| Overall score of combined domains | 0.06 ± 0.944 | -0.031 ± 0.969 |
| Motor development | 0.06 ± 0.955 | -0.037 ± 0.963 |
| Language development | 0.048 ± 0.949 | -0.029 ± 0.993 |
| Cognitive development | 0.046 ± 0.969 | -0.027 ± 0.97 |
| Social-emotional development | 0.047 ± 0.978 | -0.028 ± 0.971 |
The MDAT measures gross motor (39 items), fine motor (42 items), language/cognition (40 items) and social skills (36 items). Originally developed and validated in rural Malawi, it has now been used in over 25 countries as both a clinical and research tool. The MDAT is a continuous test with start and stop rules. Most items are administered directly to the child and items that are not easily observed (e.g., child speaks in full sentences; child understands sharing with others; child can dress self) are administered by parent report. Children receive either a pass or fail for each item, and summed pass scores can produce a composite score as well as domain-specific scores. Total scores range from 0 to 157 where higher scores indicate greater neurodevelopment. Both domain-specific and overall z-scores are calculated (mean = 0, standard deviation = 1). Z-scores of 0 mean the child has a similar developmental status to the average child. Scores above 0 are higher than the sample reference.
| z-score | Liquefied Petroleum Gas Cookstove - Offspring of Pregnant Women | Control - Offspring of Pregnant Women |
|---|---|---|
| 48 months of age - overall score of combined domains | 0.745 ± 0.759 | 0.099 ± 0.797 |
| 48 months of age - gross motor score | 0.115 ± 0.728 | 0.074 ± 0.769 |
| 48 months of age - fine motor score | 0.088 ± 0.871 | 0.064 ± 0.896 |
| 48 months of age - language/cognition score | 0.101 ± 0.852 | 0.079 ± 0.859 |
| 48 months of age - social skills score | 0.156 ± 0.676 | 0.085 ± 0.732 |
| 60 months of age - overall score of combined domains | 0.094 ± 0.826 | 0.084 ± 0.820 |
| 60 months of age - gross motor score | 0.053 ± 0.812 | 0.091 ± 0.825 |
| 60 months of age - fine motor score | 0.064 ± 0.868 | 0.063 ± 0.866 |
| 60 months of age - language/cognition score | 0.078 ± 0.849 | 0.078 ± 0.869 |
| 60 months of age - social skills score | 0.097 ± 0.778 | 0.024 ± 0.822 |
Blood pressure is assessed in the pregnant women in the intervention and control arms using automatic sphygmomanometers (OMRON HEM-907XL; Osaka, Japan). The study team will use the procedures adapted from previously validated methods and cardiovascular outcome studies, following recommendations for the American Heart Association and the European Society of Hypertension.
| mmHg | Liquefied Petroleum Gas Cookstove - Pregnant Women | Control - Pregnant Women |
|---|---|---|
| Baseline (9 - 20 Weeks Gestation) | 104.5 ± 9.7 | 105.3 ± 9.6 |
| 24 - 28 Weeks Gestation | 104.1 ± 8.8 | 104.4 ± 8.7 |
| 32 - 36 Weeks Gestation | 105.8 ± 8.7 | 105.8 ± 8.8 |
Blood pressure is assessed in the pregnant women in the intervention and control arms using automatic sphygmomanometers (OMRON HEM-907XL; Osaka, Japan). The study team will use the procedures adapted from previously validated methods and cardiovascular outcome studies, following recommendations for the American Heart Association and the European Society of Hypertension. Diastolic blood pressure levels of less than 80 are considered normal.
| mmHg | Liquefied Petroleum Gas Cookstove - Pregnant Women | Control - Pregnant Women |
|---|---|---|
| Baseline: 9 - 20 Weeks Gestation | 60.6 ± 7.7 | 60.8 ± 7.8 |
| 24 - 28 Weeks Gestation | 60.4 ± 7.6 | 59.7 ± 7.2 |
| 32 - 36 Weeks Gestation | 62.9 ± 8.0 | 62.5 ± 7.5 |
Diastolic blood pressure is assessed in the older adult women in the intervention and control arms using automatic sphygmomanometers (Omron HEM-907XL; Osaka, Japan). The study team uses the procedures adapted from previously validated methods and cardiovascular outcome studies, following recommendations for the American Heart Association and the European Society of Hypertension. Diastolic blood pressure levels of less than 80 are considered normal. Diastolic blood pressure collected at 3, 6, 9, 12, and 18 months post-randomization time points are averaged together for a single post-randomization value.
| mmHg | Liquefied Petroleum Gas Cookstove - Older Adult Women in Household of Pregnant Women | Control - Older Adult Women in Household of Pregnant Women |
|---|---|---|
| Baseline | 70.1 ± 10.8 | 69.3 ± 10.5 |
| Average Post-randomization (up to 18 months post-randomization) | 68.0 ± 9.1 | 68.7 ± 9.1 |
Mean arterial pressure is assessed in the older adult women in the intervention and control arms using automatic sphygmomanometers (Omron HEM-907XL; Osaka, Japan). Mean arterial pressure is calculated as DBP+(SBP-DBP)/3, where SBP=systolic blood pressure and DBP=diastolic blood pressure. Arterial blood pressure collected at 3, 6, 9, 12, and 18 months post-randomization time points are averaged together for a single post-randomization value.
| millimeters of mercury (mmHg) | Liquefied Petroleum Gas Cookstove - Older Adult Women in Household of Pregnant Women | Control - Older Adult Women in Household of Pregnant Women |
|---|---|---|
| Baseline | 84.9 ± 11.8 | 84.3 ± 11.5 |
| Average post-randomization | 82.5 ± 10.0 | 83.1 ± 9.8 |
Pulse pressure is assessed in the older adult women in the intervention and control arms using automatic sphygmomanometers (Omron HEM-907XL; Osaka, Japan). pressure. Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP). A normal pulse pressure is 40 mmHg and pulse pressure tends to increase above age 50 as arteries stiffen. Pulse pressure collected at 3, 6, 9, 12, and 18 months post-randomization time points are averaged together for a single post-randomization value.
| millimeters of mercury (mmHg) | Liquefied Petroleum Gas Cookstove - Older Adult Women in Household of Pregnant Women | Control - Older Adult Women in Household of Pregnant Women |
|---|---|---|
| Baseline | 44.5 ± 8.6 | 45.2 ± 8.9 |
| Average post-randomization | 43.5 ± 7.5 | 43.1 ± 7.3 |
Pregnant women have ultrasounds during gestation weeks 24-28 and gestation weeks 32-36 to measure fetal growth. Specifically, the researchers evaluated head circumference (HC), abdominal circumference (AC), femur length (FL) and estimated fetal weight (EFW) during gestation. The researchers calculated z-scores for head circumference, abdominal circumference, femur length and estimated fetal weight at the gestational age using World Health Organization (WHO) INTERGROWTH 21st standards. Z-scores have a mean of 0 and a standard deviation of 1. Z-scores over 0 indicate above average measurements, while a negative z-score indicates measurements are lower than average.
| z-score | Liquefied Petroleum Gas Cookstove - Pregnant Women | Control - Pregnant Women |
|---|---|---|
| Gestation Week 24-28 - Head Circumference | 0.35 ± 1.12 | 0.49 ± 1.09 |
| Gestation Week 32-36 - Head Circumference | 0.30 ± 1.19 | 0.31 ± 1.20 |
| Gestation Week 24-28 - Abdominal Circumference | 0.46 ± 1.18 | 0.49 ± 1.17 |
| Gestation Week 32-36 - Abdominal Circumference | 0.36 ± 1.11 | 0.34 ± 1.13 |
| Gestation Week 24-28 - Femur Length | 0.40 ± 1.16 | 0.46 ± 1.11 |
| Gestation Week 32-36 - Femur Length | 0.46 ± 1.06 | 0.44 ± 1.11 |
| Gestation Week 24-28 - Fetal Weight | 0.50 ± 1.24 | 0.58 ± 1.16 |
| Gestation Week 32-36 - Fetal Weight | 0.35 ± 1.07 | 0.33 ± 1.11 |
Gestational age at birth is measured in weeks, as a continuous outcome, among all live births.
| weeks | Liquefied Petroleum Gas Cookstove - Offspring of Pregnant Women | Control - Offspring of Pregnant Women |
|---|---|---|
| Gestational Age at Birth | 39.3 ± 1.6 | 39.3 ± 1.7 |
Preterm birth is defined as delivery of a living infant prior to 37 completed weeks of gestation.
| Participants | Liquefied Petroleum Gas Cookstove - Offspring of Pregnant Women | Control - Offspring of Pregnant Women |
|---|---|---|
| Number of Offspring Born Preterm | 90 | 83 |
Cumulative incidence of WHO non-severe pneumonia (2014 definition and 2013 definition) during the first year of life. Cases of pneumonia are recorded whenever children present to HAPIN health facilities with respiratory symptoms.
| Participants | Liquefied Petroleum Gas Cookstove - Offspring of Pregnant Women | Control - Offspring of Pregnant Women |
|---|---|---|
| Number of Offspring With WHO Defined Non-severe Pneumonia | 182 | 197 |
Cumulative incidence of WHO non-severe pneumonia (2014 definition and 2013 definition) during the first year of life. Cases of pneumonia are recorded whenever children present to HAPIN health facilities with respiratory symptoms.
| Participants | Liquefied Petroleum Gas Cookstove - Offspring of Pregnant Women | Control - Offspring of Pregnant Women |
|---|---|---|
| Number of Offspring With WHO Defined Severe Pneumonia | 129 | 138 |
Cumulative incidence of hospitalizations for a respiratory illness during the first year of life.
| Participants | Liquefied Petroleum Gas Cookstove - Offspring of Pregnant Women | Control - Offspring of Pregnant Women |
|---|---|---|
| Number of Offspring Hospitalized for Respiratory Illness | 104 | 95 |
Cumulative incidence of WHO non-severe pneumonia during the first year of life, as defined in the second edition of the "Pocket book of hospital care for children" (2013). Cases of pneumonia are recorded whenever children present to HAPIN health facilities with respiratory symptoms.
| Participants | Liquefied Petroleum Gas Cookstove - Offspring of Pregnant Women | Control - Offspring of Pregnant Women |
|---|---|---|
| Number of Offspring With WHO Pocket Book Non-severe Pneumonia | 178 | 182 |
Cumulative incidence of WHO severe pneumonia during the first year of life, as defined in the second edition of the "Pocket book of hospital care for children" (2013). Cases of pneumonia are recorded whenever children present to HAPIN health facilities with respiratory symptoms.
| Participants | Liquefied Petroleum Gas Cookstove - Offspring of Pregnant Women | Control - Offspring of Pregnant Women |
|---|---|---|
| Number of Offspring With WHO Pocket Book Severe Pneumonia | 121 | 122 |
Cumulative incidence of hypoxemic pneumonia during the first year of life. Cases of pneumonia are recorded whenever children present to HAPIN health facilities with respiratory symptoms.
| Participants | Liquefied Petroleum Gas Cookstove - Offspring of Pregnant Women | Control - Offspring of Pregnant Women |
|---|---|---|
| Number of Offspring With Hypoxemic Pneumonia | 69 | 72 |
Cumulative incidence of lung ultrasound or chest radiograph pneumonia during the first year of life. Cases of pneumonia are recorded whenever children present to HAPIN health facilities with respiratory symptoms.
| Participants | Liquefied Petroleum Gas Cookstove - Offspring of Pregnant Women | Control - Offspring of Pregnant Women |
|---|---|---|
| Number of Offspring With Ultrasound or Radiograph Pneumonia | 28 | 29 |
Brachial artery reactivity testing (BART) measures endothelial function via flow-mediated dilation (FMD) in response to reactive hyperemia following release of arm blood-flow occlusion. Using ultrasound, the brachial artery is first imaged at rest to establish the baseline (pre-occlusion) diameter. A blood pressure cuff is then inflated to induce distal arm ischemia for 5 minutes. Upon cuff release, the resulting surge in blood flow (reactive hyperemia) stimulates the artery to dilate; the artery is imaged repeatedly during this period and the maximum post-occlusion diameter is identified. The outcome, FMD, is expressed as the maximum percent change in diameter relative to baseline: FMD% = (maximum post-occlusion diameter - baseline diameter) ÷ baseline diameter × 100. Higher values indicate greater dilation and better endothelial function; lower values indicate worse endothelial function.
| percent change in artery diameter | Liquefied Petroleum Gas Cookstove - Older Adult Women in Household of Pregnant Women | Control - Older Adult Women in Household of Pregnant Women |
|---|---|---|
| Baseline | 6.38 ± 3.78 | 6.68 ± 3.41 |
| 18 months post-randomization | 6.16 ± 3.60 | 6.09 ± 3.84 |
The carotid intima-media thickness test (CIMT) is used to determine the extent of carotid atherosclerotic vascular disease. The test measures the thickness of the inner two layers (intima and media) of the carotid artery and can detect plaque build-up prior to physical symptoms being experienced. The carotid ultrasound will be performed with a portable ultrasound by trained sonographers. CIMT is a well-established imaging biomarker of atherosclerosis, where higher values indicate greater carotid arterial wall thickness and have been associated with higher cardiovascular disease risk.
| millimeters (mm) | Liquefied Petroleum Gas Cookstove - Older Adult Women in Household of Pregnant Women | Control - Older Adult Women in Household of Pregnant Women |
|---|---|---|
| Baseline | 0.644 ± 0.137 | 0.638 ± 0.116 |
| 18 months post-randomization | 0.658 ± 0.132 | 0.657 ± 0.120 |
Adult respiratory health and well-being is assessed with the St. George Respiratory Questionnaire (SGRQ). The SGRQ measures impaired health and perceived well-being among individuals with chronic airway disease. The SGRQ has sections assessing symptoms, activities that cause breathlessness or are limited because of breathlessness, and the impacts of respiratory problems on employment, sense of control of health, panic, stigmatization, medication use, side effects of therapies, expectations for health and disturbances of daily life. The questionnaire includes multiple choice, true/false and open-ended questions.
Results for this outcome have not been posted.
The Short Form 36 survey (SF-36) is a standardized, preference-based 36 item questionnaire evaluating quality of life. The survey has 8 sections (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health). Possible scores range from 0 (lowest quality of life) to 100 (highest quality of life).
Results for this outcome have not been posted.
Linear growth of children is assessed in centimeters at birth and quarterly thereafter, until the child is 12 months old. Infant recumbent length was converted to a length-for-age z-score (LAZ) using the WHO Child Growth Standards. Z-scores have a mean of 0 and a standard deviation of 1. Z-scores above 0 indicate above average length-for-age, while a negative z-score indicates lower than average length-for-age.
| z-score | Liquefied Petroleum Gas Cookstove - Offspring of Pregnant Women | Control - Offspring of Pregnant Women |
|---|---|---|
| Birth | -0.98 ± 1.11 | -1.05 ± 1.11 |
| 3 Months of Age | -1.13 ± 1.18 | -1.18 ± 1.17 |
| 6 Months of Age | -1.11 ± 1.18 | -1.08 ± 1.17 |
| 9 Months of Age | -1.18 ± 1.15 | -1.20 ± 1.14 |
| 12 Months of Age | -1.33 ± 1.16 | -1.32 ± 1.12 |
The Caregiver Reported Early Childhood Development Instrument (CREDI) is a population-level measure of early childhood development (ECD) for children from 0-3 years of age. The CREDI assesses 4 domains of child development: 1) motor (fine and gross motor), 2) language (expressive and receptive language), 3) cognitive (executive function, problem solving and reasoning, and pre-academic knowledge), and 4) socio-emotional (emotional and behavioral self-regulation, emotional knowledge, and social competence). The CREDI long form consists of up to 108 items and the number of questions answered depends on the age of the child. Responses of "yes" are coded as 1 while responses of "no" are coded as 0; certain items are reverse coded. Norm-referenced, age standardized z-scores for overall and domain-specific CREDI scores were calculated. Z-scores have a mean of 0 and standard deviation of 1; values below 0 indicate ECD scores lower than the global CREDI norm-referenced population.
| z-score | Liquefied Petroleum Gas Cookstove - Offspring of Pregnant Women | Control - Offspring of Pregnant Women |
|---|---|---|
| Overall | -0.589 ± 0.796 | -0.614 ± 0.789 |
| Cognitive | -0.707 ± 0.773 | -0.718 ± 0.781 |
| Motor | -0.577 ± 0.791 | -0.595 ± 0.784 |
| Language | -0.750 ± 0.846 | -0.802 ± 0.860 |
| Socio-emotional | -0.590 ± 0.866 | -0.596 ± 0.859 |
Height is measured in meters. Height in new mothers in Rwanda is measured when the child is 24 months old. For new mothers in Guatemala height is measured when the child is 24 and 36 months old. In older adult women, height is measured when the child is 24-months old.
Results for this outcome have not been posted.
Weight is measured in kilograms (kg). Weight in new mothers in Rwanda is measured when the child is 24 months old. For new mothers in Guatemala weight is measured when the child is 24 and 36 months old. In older adult women, weight is measured when the child is 24 months old. Weight is measured in children at 24, 36, 48 and 60 months of age.
Results for this outcome have not been posted.
BMI is calculated as weight in kilograms divided by height in meters (m) squared (kg/m\^2). BMI in new mothers in Rwanda is calculated from height and weight measurements obtained when the child is 24 months old. For new mothers in Guatemala BMI is calculated from height and weight measurements obtained when the child is 24 and 36 months old. In older adult women, BMI is calculated from height and weight measurements obtained when the child is 24 months old.
Results for this outcome have not been posted.
Blood pressure is assessed in the children using automatic sphygmomanometers (OMRON HEM-907XL; Osaka, Japan). The study team uses the procedures adapted from previously validated methods and cardiovascular outcome studies, following recommendations for the American Heart Association and the European Society of Hypertension.
Results for this outcome have not been posted.
Blood pressure is assessed in the new mothers in the intervention and control arms using automatic sphygmomanometers (OMRON HEM-907XL; Osaka, Japan). The study team will use the procedures adapted from previously validated methods and cardiovascular outcome studies, following recommendations for the American Heart Association and the European Society of Hypertension.
Results for this outcome have not been posted.
Blood pressure is assessed in the new mothers in the intervention and control arms using automatic sphygmomanometers (OMRON HEM-907XL; Osaka, Japan). The study team will use the procedures adapted from previously validated methods and cardiovascular outcome studies, following recommendations for the American Heart Association and the European Society of Hypertension.
Results for this outcome have not been posted.
Personal monitoring equipment is used to assess exposure to fine particulate matter (PM2.5) over a 24-hour period in intervention and control participants (pregnant women, older adult women, and children). Exposure for pregnant women is measured at baseline, 24-28 weeks gestation, 32-36 weeks gestation, and in Guatemala and India, when the child is 24 months old. Exposure for the child is measured at 3, 6, 12, 24, 36, 48 and 60 months of age. Exposure for the older adult women is measured at baseline, 3, 6, 12 and 18 months post-randomization, and in Guatemala and India, when the child is 24 months old.
Results for this outcome have not been posted.
Personal monitoring equipment is used to assess exposure to carbon monoxide (CO) over a 24-hour period in intervention and control participants (pregnant women, older adult women, and children). Exposure for pregnant women is measured at baseline, 24-28 weeks gestation, 32-36 weeks gestation, and in Guatemala and India, when the child is 24 months old. Exposure for the child is measured at 3, 6, 12, 24, 36, 48 and 60 months of age. Exposure for the older adult women is measured at baseline, 3, 6, 12 and 18 months post-randomization, and in Guatemala and India, when the child is 24 months old.
Results for this outcome have not been posted.
Personal monitoring equipment is used to assess exposure to black carbon (BC) over a 24-hour period in intervention and control participants (pregnant women, older adult women, and children). Exposure for pregnant women is measured at baseline, 24-28 weeks gestation, 32-36 weeks gestation, and in Guatemala and India, when the child is 24 months old. Exposure for the child is measured at 3, 6, 12, 24, 36, 48 and 60 months of age. Exposure for the older adult women is measured at baseline, 3, 6, 12 and 18 months post-randomization, and in Guatemala and India, when the child is 24 months old.
Results for this outcome have not been posted.
The 10-item Cohen's Perceived Stress Scale (PPS) assesses the way an individual appraises their life events as stressful (e.g., "In the last month, how often have you felt difficulties were piling up so high that you could not overcome them?") (Cohen, 1983). Likert-level responses ranged from 0 (never) to 4 (very often), meaning a high PPS score would result in a high level of perceived stress. A Spanish language PPS created and tested and found to be valid and reliable (Vallijo et al., 2018).
Results for this outcome have not been posted.
Fetal death before 19 weeks 6 days.
Results for this outcome have not been posted.
Births at less than 34 weeks completed gestation, among all live births.
Results for this outcome have not been posted.
Including preterm birth and stillbirth.
Results for this outcome have not been posted.
Any fetal deaths occurring at or after 20 weeks' gestation OR indicated on Serious Adverse Event form OR on Pregnant Woman Medical History form OR on verbal autopsy form.
Results for this outcome have not been posted.
Death between birth and 28 days.
Results for this outcome have not been posted.
Two buccal cell scrapes will be collected by gently scraping the buccal mucosa on both sides of the mouth with a small plastic collection spoon. Nasal turbinate brush samples can be collected using a soft cytobrush on each turbinate. Collection is gentle and causes no discomfort to study participants. Both samples will be processed in the laboratory according to procedures detailed in the protocol. This will occur in the older adult women in an NCI substudy.
Results for this outcome have not been posted.
For the oral rinse, participants will vigorously rinse their mouth and the rinsates are collected in a centrifuge tube. The tube is centrifuged and the pellet and supernatant are removed to separate cryovials, labeled and frozen. This will occur in the older adult women in an NCI substudy.
Results for this outcome have not been posted.
Two buccal cell scrapes will be collected by gently scraping the buccal mucosa on both sides of the mouth with a small plastic collection spoon. A 5-mL venous blood sample will be collected in an ethylenediaminetetraacetic acid (EDTA) vacutainer tube by standard clinical venipuncture of a cubital vein. Both samples will be transported and processed in the laboratory according to procedures detailed in the protocol. This will occur in the older adult women in an NCI substudy.
Results for this outcome have not been posted.
A 5-mL venous blood sample will be collected in an EDTA vacutainer tube by standard clinical venipuncture of a cubital vein. The sample will be transported and processed in the laboratory according to procedures detailed in the protocol. This will occur in the older adult women in an NCI substudy.
Results for this outcome have not been posted.
Household food insecurity will be measured using the Food Insecurity Experience Scale (FIES), developed and validated by the Food and Agriculture Organization (FAO). The FIES module includes eight questions, each with yes/no response options, on the household's access to adequate food, and is intended to measure three domains of food insecurity: uncertainty/anxiety, food quantity, and food quality. Each question takes values of 0/1, which are summed for a possible total score of 0-8.
Results for this outcome have not been posted.
Dietary diversity for women will be measured using the Minimum Dietary Diversity - Women (MDD-W) questionnaire from the FAO and FHI 360, which uses an open recall format to collect data on foods and beverages consumed by the respondent during the previous day and night. Responses will be categorized into ten food groups and women who report consuming five or more out of ten food groups will be categorized as achieving minimum dietary diversity.
Results for this outcome have not been posted.
Minimum dietary diversity for children will be measured using the World Health Organization (WHO) infant and young child feeding questionnaire. The questionnaire uses a combination of open and closed recall and asks caregivers to report on foods and beverages consumed by the infant or young child during the previous day and night. Responses will be categorized into eight food groups and infants who consumed five or more out of ten eight food groups will be categorized as achieving minimum dietary diversity.
Results for this outcome have not been posted.
Hb will be measured from a single drop of capillary blood obtained via finger prick, using the HemoCue® Hb 201system (HemoCue® AB) point-of-care device
Results for this outcome have not been posted.
Hb will be measured from a single drop of capillary blood obtained via finger prick, using the HemoCue® Hb 201system (HemoCue® AB) point-of-care device
Results for this outcome have not been posted.
Lung function measurements will be made using the forced oscillation technique (FOT) with the Tremoflo C-100 device with disposable mouthpieces. FOT is a technique that can identify early changes in the airways. The FOT device measures the relationship between externally applied pressure waves and the resulting air flow to measure respiratory impedance. Values produced at high frequencies correspond to the proximal and large airways, and values produced at low frequencies correspond to distal and small airways. This measurement will be conducted in children in Guatemala.
Results for this outcome have not been posted.
The carotid intima-media thickness test (CIMT) is used to determine the extent of carotid atherosclerotic vascular disease. The test measures the thickness of the inner two layers of the carotid artery and can detect plaque build up prior to physical symptoms being experienced. The carotid ultrasound will be performed with a portable ultrasound by trained sonographers. This outcome is only assessed in Guatemala during the extended follow-up period (after the birth of the household child).
Results for this outcome have not been posted.
Multiple exposure biomarkers will be measured: 3-OH Cotinine, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), levoglucosan, 8OH-deoxyguanosine (8OHdG), and Volatile Organic Chemicals (VOC) metabolites. Exposure biomarkers (especially for children whose urine may be limited) will be prioritized as follows: polycyclic aromatic hydrocarbon (PAH) biomarkers, levoglucosan, volatile organic chemicals (VOC) biomarkers, heavy metals, and tobacco-related biomarkers. Urinary biomarkers will be measured in pregnant women at baseline, 24-28 weeks gestation, and 32-36 weeks gestation, and in new mothers when the child is 24-months old. Biomarkers will be measured in older adult women at baseline, 3, 6, 9, 12 and 18 months post-randomization. Biomarkers will be measured in children at 3, 6, 12 and 24 months of age.
Results for this outcome have not been posted.
The main biomarkers to be measured from the dried blood spots is: inflammation markers, endothelial markers of cardiovascular disease, oxidative stress markers, Hb, HbA1C, tumor-associated antigen antibodies, cytochrome P450, p53 tumor-associated antigen (TAA), lipids, metabolomics, MiRNA, heavy metals. DBS biomarkers will be measured in pregnant women at baseline, 24-28 weeks gestation, and 32-36 weeks gestation, and in new mothers when the child is 24-months old. DBS biomarkers will be measured in older adult women at baseline, 3, 6, 9, 12 and 18 months post-randomization. DBS biomarkers will be measured in children at 3, 6, 12 and 24 months of age.
Results for this outcome have not been posted.
Reported diarrhea will be extracted from the Monthly Child Health Status Visit case report form. Each month, the child's caretaker will be administered a survey to obtain information on whether the child under 1 year of age (the HAPIN study index child) or any other child in the home under 5 has experienced WHO-defined diarrhea (defined as three or more loose stools that can take the shape of a container within a 24-hour period) in the past 7 days. Persistent diarrhea will be defined as 14 or more continuous days of diarrhea. The presence of blood in the stool will also be noted as an indicator of severity.
Results for this outcome have not been posted.
Collected over Information on adverse events was collected from the time participants entered the study through the final extended follow-up visit at 60 months of age of the offspring (up to 71 months).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Liquefied Petroleum Gas Cookstove - Pregnant Women During Main Trial | 3/1,593 (0.2%) | 323/1,593 (20.3%) | 80/1,593 (5%) |
| Liquefied Petroleum Gas Cookstove - Offspring of Pregnant Women During Main Trial | 28/1,536 (1.8%) | 148/1,536 (9.6%) | 23/1,536 (1.5%) |
| Liquefied Petroleum Gas Cookstove - Older Adult Women in Household During Main Trial | 1/217 (0.5%) | 1/217 (0.5%) | 29/217 (13.4%) |
| Control - Pregnant Women During Main Trial | 2/1,607 (0.1%) | 314/1,607 (19.5%) | 72/1,607 (4.5%) |
| Control - Offspring of Pregnant Women During Main Trial | 36/1,525 (2.4%) | 133/1,525 (8.7%) | 30/1,525 (2%) |
| Control - Older Adult Women in Household During Main Trial | 0/226 (0%) | 0/226 (0%) | 30/226 (13.3%) |
| Liquefied Petroleum Gas Cookstove - Pregnant Women During Extended Follow-up | 0/1,071 (0%) | 2/1,071 (0.2%) | 3/1,071 (0.3%) |
| Liquefied Petroleum Gas Cookstove - Offspring of Pregnant Women During Extended Follow-up | 7/1,071 (0.7%) | 15/1,071 (1.4%) | 9/1,071 (0.8%) |
| Liquefied Petroleum Gas Cookstove - Older Adult Women in Household During Extended Follow-up | 1/106 (0.9%) | 0/106 (0%) | 4/106 (3.8%) |
| Control - Pregnant Women During Extended Follow-up | 0/1,101 (0%) | 1/1,101 (0.1%) | 1/1,101 (0.1%) |
| Control - Offspring of Pregnant Women During Extended Follow-up | 6/1,101 (0.5%) | 17/1,101 (1.5%) | 10/1,101 (0.9%) |
| Control - Older Adult Women in Household During Extended Follow-up | 4/102 (3.9%) | 0/102 (0%) | 0/102 (0%) |
| Event | Liquefied Petroleum Gas Cookstove - Pregnant Women During Main Trial | Liquefied Petroleum Gas Cookstove - Offspring of Pregnant Women During Main Trial | Liquefied Petroleum Gas Cookstove - Older Adult Women in Household During Main Trial | Control - Pregnant Women During Main Trial | Control - Offspring of Pregnant Women During Main Trial | Control - Older Adult Women in Household During Main Trial | Liquefied Petroleum Gas Cookstove - Pregnant Women During Extended Follow-up | Liquefied Petroleum Gas Cookstove - Offspring of Pregnant Women During Extended Follow-up | Liquefied Petroleum Gas Cookstove - Older Adult Women in Household During Extended Follow-up | Control - Pregnant Women During Extended Follow-up | Control - Offspring of Pregnant Women During Extended Follow-up | Control - Older Adult Women in Household During Extended Follow-up |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Emergency cesarean sectionSurgical and medical procedures | 201/1593 | 0/1536 | 0/217 | 182/1607 | 0/1525 | 0/226 | 0/1071 | 0/1071 | 0/106 | 0/1101 | 0/1101 | 0/102 |
| StillbirthPregnancy, puerperium and perinatal conditions | 29/1593 | 0/1536 | 0/217 | 29/1607 | 0/1525 | 0/226 | 0/1071 | 0/1071 | 0/106 | 0/1101 | 0/1101 | 0/102 |
| PneumoniaInfections and infestations | 0/1593 | 25/1536 | 0/217 | 1/1607 | 24/1525 | 0/226 | 0/1071 | 0/1071 | — | 0/1101 | 0/1101 | — |
| Preterm laborPregnancy, puerperium and perinatal conditions | 16/1593 | 0/1536 | 0/217 | 12/1607 | 0/1525 | 0/226 | 0/1071 | 0/1071 | 0/106 | 0/1101 | 0/1101 | 0/102 |
| Congenital anomalyCongenital, familial and genetic disorders | 0/1593 | 11/1536 | 0/217 | 0/1607 | 13/1525 | 0/226 | 0/1071 | 0/1071 | 0/106 | 0/1101 | 0/1101 | 0/102 |
| Respiratory illnessRespiratory, thoracic and mediastinal disorders | 0/1593 | 11/1536 | 0/217 | 0/1607 | 9/1525 | 0/226 | 0/1071 | 0/1071 | 0/106 | 0/1101 | 0/1101 | 0/102 |
| Cesarean section deliverySurgical and medical procedures | 4/1593 | 0/1536 | 0/217 | 11/1607 | 0/1525 | 0/226 | 0/1071 | 0/1071 | 0/106 | 0/1101 | 0/1101 | 0/102 |
| Low birth weightGeneral disorders | 0/1593 | 3/1536 | 0/217 | 0/1607 | 10/1525 | 0/226 | 0/1071 | 0/1071 | 0/106 | 0/1101 | 0/1101 | 0/102 |
| Preterm with low birth weightPregnancy, puerperium and perinatal conditions | 0/1593 | 10/1536 | 0/217 | 1/1607 | 8/1525 | 0/226 | 0/1071 | 0/1071 | 0/106 | 0/1101 | 0/1101 | 0/102 |
| Preeclampsia or eclampsiaPregnancy, puerperium and perinatal conditions | 10/1593 | 0/1536 | 0/217 | 5/1607 | 0/1525 | 0/226 | 0/1071 | 0/1071 | 0/106 | 0/1101 | 0/1101 | 0/102 |
| Event | Liquefied Petroleum Gas Cookstove - Pregnant Women During Main Trial | Liquefied Petroleum Gas Cookstove - Offspring of Pregnant Women During Main Trial | Liquefied Petroleum Gas Cookstove - Older Adult Women in Household During Main Trial | Control - Pregnant Women During Main Trial | Control - Offspring of Pregnant Women During Main Trial | Control - Older Adult Women in Household During Main Trial | Liquefied Petroleum Gas Cookstove - Pregnant Women During Extended Follow-up | Liquefied Petroleum Gas Cookstove - Offspring of Pregnant Women During Extended Follow-up | Liquefied Petroleum Gas Cookstove - Older Adult Women in Household During Extended Follow-up | Control - Pregnant Women During Extended Follow-up | Control - Offspring of Pregnant Women During Extended Follow-up | Control - Older Adult Women in Household During Extended Follow-up |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| HypertensionVascular disorders | 17/1593 | 0/1536 | 23/217 | 15/1607 | 0/1525 | 15/226 | 1/1071 | 0/1071 | 4/106 | 1/1101 | 0/1101 | 0/102 |
| BurnInjury, poisoning and procedural complications | 44/1593 | 4/1536 | 2/217 | 36/1607 | 7/1525 | 10/226 | 2/1071 | 7/1071 | 0/106 | 0/1101 | 4/1101 | 0/102 |
| DiabetesEndocrine disorders | 0/1593 | 0/1536 | 6/217 | 0/1607 | 0/1525 | 8/226 | 0/1071 | 0/1071 | 0/106 | 0/1101 | 0/1101 | 0/102 |
| Severe acute malnutritionMetabolism and nutrition disorders | 1/1593 | 12/1536 | 0/217 | 0/1607 | 20/1525 | 0/226 | 0/1071 | 1/1071 | 0/106 | 0/1101 | 6/1101 | 0/102 |
| Severe anemiaBlood and lymphatic system disorders | 6/1593 | 4/1536 | 0/217 | 14/1607 | 3/1525 | 0/226 | 0/1071 | 0/1071 | 0/106 | 0/1101 | 0/1101 | 0/102 |
| Motorcycle accidentInjury, poisoning and procedural complications | 0/1593 | 0/1536 | 0/217 | 0/1607 | 0/1525 | 1/226 | 0/1071 | 0/1071 | 0/106 | 0/1101 | 0/1101 | 0/102 |
| Cyanosis, received oxygenRespiratory, thoracic and mediastinal disorders | 0/1593 | 0/1536 | 0/217 | 0/1607 | 0/1525 | 1/226 | 0/1071 | 0/1071 | 0/106 | 0/1101 | 0/1101 | 0/102 |
| Miscarriage (<20 weeks gestation)Pregnancy, puerperium and perinatal conditions | 7/1593 | 0/1536 | 0/217 | 3/1607 | 0/1525 | 0/226 | 0/1071 | 0/1071 | 0/106 | 0/1101 | 0/1101 | 0/102 |
| Urinary tract infection (UTI)Infections and infestations | 0/1593 | 0/1536 | 0/217 | 2/1607 | 0/1525 | 0/226 | 0/1071 | 0/1071 | 0/106 | 0/1101 | 0/1101 | 0/102 |
| Possible reaction to salbutamol following respiratory oscillometrySurgical and medical procedures | 0/1593 | 0/1536 | 0/217 | 0/1607 | 0/1525 | 0/226 | 0/1071 | 1/1071 | 0/106 | 0/1101 | 0/1101 | — |
The baseline analysis does not include pregnant women who were removed from the study after randomization due to ineligibility. Offspring are not included as they were not yet born at the baseline assessment.
| Age, Continuous(years) | Liquefied Petroleum Gas Cookstove - Pregnant Women | Liquefied Petroleum Gas Cookstove - Older Adult Women in Household of Pregnant Women | Control - Pregnant Women | Control - Older Adult Women in Household of Pregnant Women | Total |
|---|---|---|---|---|---|
| Mean | — | 52.3 ± 8.2 | — | 52.0 ± 7.6 | 52.2 ± 7.9 |
| Age, Customized(Participants) | Liquefied Petroleum Gas Cookstove - Pregnant Women | Liquefied Petroleum Gas Cookstove - Older Adult Women in Household of Pregnant Women | Control - Pregnant Women | Control - Older Adult Women in Household of Pregnant Women | Total |
|---|---|---|---|---|---|
| < 20 years old | 189 | — | 209 | — | 398 |
| 20 - 24 years old | 616 | — | 579 | — | 1195 |
| 25 - 29 years old | 500 | — | 517 | — | 1017 |
| 30 - 35 years old | 285 | — | 300 | — | 585 |
| Sex: Female, Male(Participants) | Liquefied Petroleum Gas Cookstove - Pregnant Women | Liquefied Petroleum Gas Cookstove - Older Adult Women in Household of Pregnant Women | Control - Pregnant Women | Control - Older Adult Women in Household of Pregnant Women | Total |
|---|---|---|---|---|---|
| Female | 1590 | 216 | 1605 | 226 | 3637 |
| Male | 0 | 0 | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Liquefied Petroleum Gas Cookstove - Pregnant Women | Liquefied Petroleum Gas Cookstove - Older Adult Women in Household of Pregnant Women | Control - Pregnant Women | Control - Older Adult Women in Household of Pregnant Women | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
| Region of Enrollment(Participants) | Liquefied Petroleum Gas Cookstove - Pregnant Women | Liquefied Petroleum Gas Cookstove - Older Adult Women in Household of Pregnant Women | Control - Pregnant Women | Control - Older Adult Women in Household of Pregnant Women | Total |
|---|---|---|---|---|---|
| Rwanda | 394 | 19 | 404 | 24 | 841 |
| Guatemala | 400 | 72 | 400 | 70 | 942 |
| Peru | 396 | 71 | 402 | 79 | 948 |
| India | 400 | 54 | 399 | 53 | 906 |
| Gestational age in weeks(weeks) | Liquefied Petroleum Gas Cookstove - Pregnant Women | Liquefied Petroleum Gas Cookstove - Older Adult Women in Household of Pregnant Women | Control - Pregnant Women | Control - Older Adult Women in Household of Pregnant Women | Total |
|---|---|---|---|---|---|
| Mean | 15.5 ± 3.2 | — | 15.3 ± 3.2 | — | 15.4 ± 3.2 |
| Nulliparous(Participants) | Liquefied Petroleum Gas Cookstove - Pregnant Women | Liquefied Petroleum Gas Cookstove - Older Adult Women in Household of Pregnant Women | Control - Pregnant Women | Control - Older Adult Women in Household of Pregnant Women | Total |
|---|---|---|---|---|---|
| Yes | 639 | — | 589 | — | 1228 |
| No | 947 | — | 1014 | — | 1961 |
| Missing | 4 | — | 2 | — | 6 |
| Highest level of education completed(Participants) | Liquefied Petroleum Gas Cookstove - Pregnant Women | Liquefied Petroleum Gas Cookstove - Older Adult Women in Household of Pregnant Women | Control - Pregnant Women | Control - Older Adult Women in Household of Pregnant Women | Total |
|---|---|---|---|---|---|
| No formal education or primary school incomplete | 481 | 170 | 558 | 173 | 1382 |
| Primary school complete / secondary school incomplete | 558 | 34 | 533 | 32 | 1157 |
| Secondary school complete or vocational school or some college or university | 550 | 3 | 514 | 7 | 1074 |
| Missing | 1 | 9 | 0 | 14 | 24 |
3 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Thompson LM, de Leon O, Sinharoy S, Valdes V, Das S, Aravindalochanan V, Pillarisetti A, Jabbarzadeh S, Balakrishnan K, Diaz-Artiga A, McCracken JP, Rosa G, Th…PubMed 42241937 ↗; 1 more
Thompson LM, de Leon O, Sinharoy S, Valdes V, Das S, Aravindalochanan V, Pillarisetti A, Jabbarzadeh S, Balakrishnan K, Diaz-Artiga A, McCracken JP, Rosa G, Th…PubMed 42241937 ↗; 1 more
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