An observational study in Weight Gain, Pregnancy, Microbial Colonization and Pregnancy Related, sponsored by Aga Khan University. Active, not recruiting at 1 site in Pakistan. Open to female participants aged 17 Years to 24 Years. Per ClinicalTrials.gov, last updated 2024-07-15.
Sponsored by Aga Khan University · Observational
Nutritional status during pregnancy plays an important role in maternal health and birth outcomes. While few factors impacting nutritional status during pregnancy have been identified, studies of undernutrition in children have revealed a key role for the gut microbiome. Remarkably, studies examining the dynamics of the maternal gut microbiome before and during pregnancy and its impact on birth outcomes are limited.
This study is being conducted to investigate how a mother's nutritional status and her gut microbiome during pregnancy contribute to the birth outcomes and health of her baby. The gut microbiome is the totality of microorganisms (e.g. bacteria, viruses, fungi) living in the gastrointestinal tract. This study will focus on married pregnant women 24 years and younger living in Matiari District in Pakistan. The focus is on younger women due to their vulnerability to undernutrition. Pregnant participants, and upon delivery, their newborns will be followed throughout pregnancy and for a year afterwards. Throughout this period, the investigators will collect stool samples, rectal swabs, blood samples, health assessments, nutritional and dietary assessments and birth/ labour details. The goal is to define the relationship between a mother's nutritional status and her microbiome dynamics during pregnancy and how they contribute to the birth outcomes and growth of her newborn. Investigators hypothesizes that alterations of the microbiota in the maternal gut (dysbiosis) is exacerbated by nutritional status or pathogen exposure during pregnancy. This impacts weight gain because of impaired nutrient absorption, and can lead to corresponding negative birth outcomes.
This project represents the first systematic investigation of the impact of the microbiome on nutritional status during pregnancy in young women and directly aligns with global health initiatives focused on this vulnerable cohort. The goal of the study is to define the relationships between host nutritional status and microbiome dynamics during pregnancy and how they contribute to birth outcomes. The gut microbiome has a profound influence on host nutritional status. Dysbiosis (loss of diversity/beneficial microbes and gain of pathobionts) has emerged as a major factor in the development of undernutrition. Despite the importance of nutrition during pregnancy, few studies have examined the role of the microbiome on maternal health and birth outcomes. Further, little is known concerning the influence of enteric eukaryotic microbes, such as parasites, on the bacterial microbiome and host nutrition.
At the core of this study are two complementary cohorts of young women that provide an exceptional opportunity to obtain longitudinal samples to monitor the dynamic relationships between microbiome community structure and function with gut health and host nutritional status. This registration is for the Matiari, Pakistan cohort of the study, where there is known to be a high prevalence of undernutrition among young women. This cohort is expected to yield insights into the influence of eukaryotic microbes that are often viewed as asymptomatic. The target demographic of the study is young, married mothers, ≤24 years in Matiari District within the province of Sindh, Pakistan. Matiari District is representative of rural settings in Pakistan The investigators have identified this younger demographic due to the lack of knowledge on the microbiome of young women, and their vulnerability to undernutrition. A second complementary cohort will be based Toronto, Canada. This project will yield insights into the relationships between prokaryotic and eukaryotic microbes in the gut and their associations with maternal health and birth outcomes.
The central hypothesis of the study is that alterations of the microbiota in the maternal gut (dysbiosis) exacerbated by nutritional status or pathogen exposure during pregnancy, impacts weight gain because of impaired nutrient absorption, leading to corresponding negative birth outcomes.
The study will be a prospective, longitudinal, observational study to investigate the impact and relationship between prokaryotic and eukaryotic microbes in the gut and their association with maternal health and birth outcomes among married young women ≤24 years residing in Matiari District. . The study will aim to recruit 400 women into two groups based on BMI at time of recruitment (normal BMI will be defined as between 20 and 24.9 kg/m2 and low BMI will be defined as less than 20 kg/m2). With a goal of having 200 participants within the normal BMI group and 200 participants within the low BMI group. Although this is the recruitment aim, in the event that the investigators are unable to recruit 200 women with a low BMI, more women will be recruited that fall within the normal BMI range. The study will follow women and their infants over the course of their pregnancy and for a year postpartum, collecting stool, rectal and blood samples, nutritional information, heath assessments, anthropometric measurements and empowerment metrics at different time points.
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This study will examine young, married women ≤24 years living in Matiari District, Pakistan. The investigators focus on younger women, due to the lack of knowledge about their microbiome and their vulnerability to undernutrition
Exclusion Criteria:
To assess if alterations of the microbiota in the maternal gut (dysbiosis) are corelated with changes in maternal gestational weight gain
The primary endpoint will be the change in maternal gestational weight gain (GWG) during pregnancy, measured between the first (8-16 weeks post-conception) and second time point (30-34 weeks post-conception)
Time frame: 8-20 weeks post-conception, 30-34 weeks post-conception
To determine the correlation between maternal microbiome dysbiosis during pregnancy and birth weight.
The primary endpoint will be change in birthweight measured in kilograms.
Time frame: At birth
To determine the correlation between maternal microbiome dysbiosis during pregnancy and infant growth
The primary endpoint will be change in WHO z-scores during first year of infant's life. These z-scores will be calculated for weight (measured in kg), length and head circumference (measured in cm).
Time frame: 3month, 6month and 12month postpartum
Anthropometrics
Maternal BMI
Time frame: 8-16 weeks post-conception, 30-34 weeks post-conception, delivery, 3-months post-partum, 6 months post-partum and 12 months post-partum ]
Anthropometrics: Maternal middle upper arm circumference
Measured in cm
Time frame: 8-16 weeks post-conception, 30-34 weeks post-conception, 3-months post-partum,and 12 months post-partum
Anthropometrics: Maternal triceps skinfold thickness
Measured in mm
Time frame: 8-16 weeks post-conception, 30-34 weeks post-conception, 3-months post-partum, and 12 months post-partum
Anthropometrics: Maternal height
measured in cm
Time frame: 8-16 weeks post conception, 30-34 weeks post conception, delivery, 3 months post-partum and 12 months post partum
Anthropometrics: Maternal weight
measured in kg
Time frame: 8-16weeks post conception, 30-34 weeks post conception, delivery, 3 months post-partum and 12 months post-partum
Maternal blood biomarker-1
Concentration of HB in g/dL, marker of anemia.
Time frame: 8-16 weeks post-conception, 30-34 weeks post-conception, and 12 months post-partum
Maternal blood biomarker-2
Level of MCV in whole blood measured in femtoliters (fL).
Time frame: 8-16 weeks post-conception, 30-34 weeks post-conception, and 12 months post-partum
Maternal blood biomarker-3
Concentration of Ferritin in serum measured in ng/mL, marker of iron stores in blood.
Time frame: 8-16 weeks post-conception, 30-34 weeks post-conception, and 12 months post-partum
Maternal blood biomarker-4
Concentration of CRP in blood, measured in mg/dL, marker of inflammation .
Time frame: 8-16 weeks post-conception, 30-34 weeks post-conception, and 12 months post-partum
Infant blood biomarker-1
Concentration of HB in g/dL, marker of anemia.
Time frame: 1 year infant age
Infant blood biomarker-2
Level of MCV in whole blood measured in femtoliters (fL).
Time frame: 1 year infant age
Infant blood biomarker-3
Concentration of Ferritin in serum measured in ng/mL, marker of iron stores in blood.
Time frame: 1 year infant age
Infant blood biomarker-4
Concentration of CRP in blood, measured in mg/dL, marker of inflammation .
Time frame: 1 year infant age
Infant sex
Male Female
Time frame: At birth
Infant morbidity
Assessed through infant health assessment questionnaire
Time frame: at 3 months, 6 months and 12 months
Maternal morbidity
Assessed through health assessment questionnaire
Time frame: 8-16 weeks post-conception, 30-34 weeks post-conception, 3 months post-partum, 6 months post-partum and 12 months post-partum
Infant growth: weight
Measured in kg
Time frame: within 72 hours of birth, 3 months, 6 months and 12 months
Infant growth: length
Measured in cm
Time frame: within 24 hours of birth, 3 months, 6 months and 12 months
Infant growth: head circumference
Measured in cm
Time frame: within 72 hours of birth, 3 months, 6 months and 12 months
Infant growth: mid upper arm circumference
Measured in cm
Time frame: within 72 hours of birth, 3 months, 6 months and 12 months
Infant growth: triceps skinfold thickness
Measured in mm
Time frame: within 72 hours of birth, 3 months, 6 months and 12 months
Gestational age at birth
Measured in weeks
Time frame: Within 72 hours of birth
Maternal age
Age between 17-24 years documented through national ID card, school certificate or through maternal recall
Time frame: 8-16 weeks post conception
Breast feeding
amount and initiation of breast feeding, top milk, formula milk and complementary feeding Based off of WHO 2010 Guidelines: Indicators for assessing infant and young child feeding practices (Part 2 Measurement)
Time frame: at birth within 72 hours, 3 months, 6 months and 12 months
Reported Maternal medicinal use
Questionnaire
Time frame: 8-16 weeks post-conception, 30-34 weeks post-conception, 3-months post-partum, 6 months post-partum and 12 months post-partum
Reported Infant medication use
Questionnaire
Time frame: at birth within 72 hours, 3 months, 6 months and 12 months
Maternal dietary intake Assessed through ASA 24 HR Dietary Recall system, completed 2x each time point
Assessed through ASA 24 HR Dietary Recall system
Time frame: Baseline 8-16 weeks post conception, 30-34 weeks post conception and 12 months post partum
Dietary diversity
Minimum Dietary Diversity Score for Women (MDD-W)
Time frame: Baseline 8-16 weeks post conception, 30-34 weeks post conception, 3 months post-partum and 12 months post partum
Household annual food insecurity
Food insecurity will be assessed using the Household Food Insecurity Access Scale (HFIAS)
Time frame: 3 months post-partum and 12 months post-partum
Generalized Self-efficacy
Self-efficacy will be measured using the Generalized Self-Efficacy scale, developed by Schwarzer and Jerusalem. A 10 item psychometric scale.
Time frame: 3 months post-partum and 12 months post partum
Perceived decision making
Questions pertaining to perceived decision-making are from the Pakistan Demographic and Health Survey (PDHS)
Time frame: 3 months post-partum and 12 months post partum
Perceived social support
Perceived social support will be measured using the Multi-dimensional Scale of Perceived Social Support (MSPSS), developed by Zimet et al.
Time frame: 3 months post-partum and 12 months post partum
Maternal demographics
Questions pertaining to demographic data are adapted from the Pakistan Demographic and Health Survey (PDHS)
Time frame: Baseline 8-16 weeks post-conception
Food insecurity
Questionnaire developed by Hager, E.R., et al., Development and validity of a 2-item screen to identify families at risk for food insecurity.
Time frame: Baseline 8-16 weeks post conception, 3 months post partum and 12 months post partum
Perceived parental stress
Perceived parental stress will be measured using the Perceived Stress Scale (PSS-10)
Time frame: 3 months post-partum and 12 months post partum
Preterm Births
Gestational age at birth in weeks
Time frame: At birth within 72 hours
Small for gestational age
Small-for-gestational-age (\<10th percentile of weight-for-gestational-age and sex as defined by Intergrowth standards)
Time frame: At birth within 72 hours
Large for gestational age
\>90th percentile of weight-for-gestational-age and sex as defined by Intergrowth standards)
Time frame: At birth within 72 hours
Delivery Assessment
Questionnaire, mode of delivery, place of birth and other description around delivery
Time frame: at birth within 72 hours of birth
Infant dietary intake
NutricheQ Questionnaire: a tool designed for toddlers aged 1 to 3 years of age, with a focus on markers for inadequate or excessive intake and dietary imbalances
Time frame: Infant age 1 year
Maternal stool biomarkers-1
Level of Calprotectin in stool a marker of intestinal inflammation, measured in μg/g.
Time frame: At baseline 8-16 weeks post conception and 30-34 weeks post conception
Maternal stool biomarkers-2
Concentration of Claudin 15 in stool a marker of intestinal permeability measured in ng/mL.
Time frame: At baseline 8-16 weeks post conception, 30-34 weeks post conception
Maternal stool biomarkers-3
Concentration of Lipocalin in stool, a marker of gut inflammation, measured in μg/mL.
Time frame: At baseline 8-16 weeks post conception and 30-34 weeks post conception
Maternal: incidence of pathobionts
As identified through 16S, 18S and ITS rDNA surveys
Time frame: Baseline, 8-16 weeks post conception, 30-34 weeks post conception, 3 months post partum and 12 months post partum
Infant: incidence of pathobionts
As identified through 16S, 18S and ITS rDNA surveys
Time frame: 3 and 12 month
Maternal: metabolomic profile of stool [Metabolites involved in central metabolism as analysed by Mass Specttrometry]
Analysis of the core metabolites involved in central metabolism. These metabolites will be analysed through Mass Spec and include short chain fatty acids, amino acids, intermediates in energy metabolism and nucleotide biosynthesis
Time frame: Baseline, 8-16 weeks post conception, 30-34 weeks post conception, 3 months post partum and 12 months post partum
Maternal gut bacteria profile
Measured through 16S rDNA sequence surveys
Time frame: Baseline, 8-16 weeks post conception, 30-34 weeks post conception, 3 months post partum and 12 months post partum
Maternal: blood metallomics profile
Measured through ICP-MS (https://www.metabolomicscentre.ca/new_service/25) - TMIC platform of metabolmics
Time frame: Baseline, 8-16 weeks post conception, 30-34 weeks post conception, 3 months post partum and 12 months post partum
Infant: blood metallomics profile
as measured through ICP-MS (https://www.metabolomicscentre.ca/new_service/25) Through TMIC platform
Time frame: Infant age 1 year
Infant: gut bacterial profile
Measured through 16S rDNA sequence surveys
Time frame: 3 month and 12 month
Maternal metabolic pathway expression profile
as measured through whole microbiome RNASeq (metatranscriptomics)
Time frame: Baseline 8-16 weeks post conception, 30-34 weeks post conception, 3 months post partum and 12 months post partum
Infant eukaryotic microbiome profile
as measured through 18S and ITS rDNA sequence surveys
Time frame: 3 & 12 Months
Maternal eukaryotic microbiome profile
as measured through 18S and ITS rDNA sequence surveys
Time frame: Baseline 8-16 weeks post conception, 30-34 weeks post conception, 3 months post partum and 12 months post partum ]
Maternal bacterial gene expression profile
as measured through whole microbiome RNASeq (metatranscriptomics) - The output of these analyses are readouts of microbial gene expression detailing biochemical activities as well as the taxa responsible.
Time frame: Baseline 8-16 weeks post conception, 30-34 weeks post conception, 3 months post partum and 12 months post partum ]
Maternal: microbiome taxonomic alpha and beta diversity
To define taxonomic diversity, species profiles from 16S, 18S and ITS rDNA data will be clustered to identify differences in community structure across samples. Alpha diversity will be measured through indices such as Chao, Shannon and Simpson indices. Beta diversity will be measured through standard indices such as Bray-Curtis distances.
Time frame: Baseline 8-16 weeks post conception, 30-34 weeks post conception, 3 months post partum and 12 months post partum ]
Infant: microbiome taxonomic alpha and beta diversity
To define taxonomic diversity, species profiles from 16S, 18S and ITS rDNA data will be clustered to identify differences in community structure across samples. Alpha diversity will be measured through indices such as Chao, Shannon and Simpson indices. Beta diversity will be measured through standard indices such as Bray-Curtis distances.
Time frame: 3 and 12 months postpartum
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — In addition to publishing findings in open access journals, the investigators will ensure all sequences and metabolomics datasets are deposited in appropriate public repositories of those who consented for this deidentified data sharing. SOPs, pathogen samples and statistical methods developed through this project will be shared with the IMPACTT research core (https://www.impactt-microbiome.ca/). Microbiome sequence data will be uploaded on the National Centre for Biotechnology Information (NCBI). The NCBI acts as a central data repository for sequence data. In line with publication standards, the investigators are required to provide access to users who may wish to follow up on analyzing the microbiome data for their own purposes. The sample analysis information, including the sequencing data and metabolomics data will be de-identified and the patient sequence data will be removed.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is active, not recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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