An interventional study of Standard counselling and Health-Video in Anemia, Antenatal Care and Birth Outcomes, sponsored by University Ghent. Completed at 1 site in Ethiopia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-06.
Sponsored by University Ghent · Not applicable, Interventional, and Prevention
Low adherence to recommended health and nutrition strategies during the critical 1000 day-window of opportunity is multifactorial but low quality communication is key limitation. Innovative strategies to improve interpersonal communication can reduce the burden and the fatigue of community health workers and may result in a greater change. The findings of this project will support governments and other stakeholders in their delivery of high impact nutrition and health practices.
This intervention aims to improve adherence to ante- and post-natal care practices and recommendations by the use of our video-based health education. These videos will be implemented through home-based counseling by trained assistants, and video-based forum participation led by community nurses and health extension workers (HEWs). During the monthly forums, the educational package will be delivered in a video form - locally prepared using multiple approaches like testimony, comedy, dramas in the form of questions and answers, group discussions and deductive approaches. Cordless projectors and locally created videos give the health community more quality control over the end message, expand the number of people reached, allow for the use of minimally trained non-expert facilitators such as the hews, and allow for contextually appropriate information. They can also be used in areas without access to electricity, helping to bridge the digital divide, and serving as a leapfrog technology for areas that would otherwise not have access to media.
In Ante- and post-natal care, low adherence to recommended health and nutrition strategies during the critical 1,000 day-window of opportunity is multifactorial, but low-quality communication is key limitation. Innovative strategies to improve interpersonal communication can reduce the burden and the fatigue of community health workers and may result in a greater change. The findings of this project will support governments and other stakeholders in their delivery of high impact nutrition and health practices.
Focused antenatal care (FANC), including iron and folic acid supplementation (IFA) is one of the main strategies to reduce maternal and child deaths. The WHO recommends at least four hospital visits during the pregnancy. Supplementation with IFA during pregnancy improves birth weight and reduces megaloblastic anemia by 79%. The uptake of nutritional and health practices is influenced by complex, contextual determinants at the individual and community levels. Evidence showed that Social and Behavior Change Communication (SBCC) is an effective approach to increase the uptake of key strategies and to sustain behavior change.
Ethiopia, a low-income country in sub-Saharan Africa, has one of the highest maternal and infant mortality rates. It is estimated that 676 mothers die per 100,000 live births and that 59 infants die per 1,000 live births. Maternal anemia is associated with an increased risk of maternal death. Iron deficiency anemia is a strong risk factor for low birthweight (LBW) and perinatal mortality. genital infections such as bacterial vaginosis, candidiasis and worm infections (such as intestinal hookworm infections) are considered important infections that possibly could confound the study results. Bacterial vaginosis and candidiasis are a known risk factor for preterm birth. these infections are also linked with anemia and maternal nutritional status. Hookworm infections are highly prevalent in Ethiopia and are associated with undernutrition and anemia.
The reports of the Ethiopian Demographic and Health Survey showed an increase in women aged 15-49 years in Ethiopia receiving antenatal care (ANC) from a skilled provider up to 62% in 2016 (EDHS, 2016). The percentage of women taking IFA supplements for 90 days or more remains at a substandard level of only 5% (EDHS, 2016). Antenatal care coverage for at least one visit is 28% but coverage for at least four visits declines to 12%, suggesting systemic barriers that potentially prevent the mothers from returning to the health centers. One of the barriers may be perceived failure of the existing interventions to make a meaningful impact that could stimulate the desired behavioral change.
This intervention aims to improve adherence to ante- and post-natal care practices and recommendations by the use of our video-based health education. These videos will be implemented through home-based counseling by trained assistants, and video-based forum participation led by community nurses and Health Extension Workers (HEWs). The nutrition-specific education packages will be based on the WHO-UNICEF key messages booklet on the community, infant and young child feeding counseling package and will be culturally adjusted to fit the local context and translated into the main four local languages. The videos will also include some hygienic aspects that reduce the risk of both genital and parasitic infections, that are also causing undernutrition, anemia and/or adverse pregnancy outcomes. During the monthly forums, the educational package will be delivered in a video form - locally prepared using multiple approaches like testimony, comedy, dramas in the form of questions and answers, group discussions and deductive approaches (more details can be found on OMPT website https://www.ompt.org/).
The main objective of this project is to assess the effects of this innovative video-based health education on reproductive health, and on birth outcomes and the nutritional status of women and their infants from birth to six months of age.
PRIMARY OBJECTIVES
The intervention will include home to home visit for delivery of healthy nutrition and hygienic messages using prepared video-based messages. participation in monthly forums will be facilitated by nurses using also videos for demonstration of nutritional and hygienic care and will be delivered at the homes of the participants every month by trained HEW until delivery, in addition to the ANC regular visits. During the monthly forums (six in total during the pregnancy and the post-partum periods), the messages will all be given as a video show, coordinated by a nurse/ health professional who will further answer any questions. During the postnatal period, two counseling sessions will be organized within the first two weeks after birth, and a further six sessions ( every month) till 6 months postnatally.
The HEW will distribute the IFA 30 tablets (30 mg elemental iron and 400 µg of folic acid) every month, and will provide counseling on the importance of- and instructions on adherence and other recommendations as detailed earlier. Pregnant women in the control group will receive the standard education package as per the Ethiopian guidelines. In the standard health care, pregnant women receive a minimum of four ANC visits at the health centers during which they also receive IFA supplementation. The control and the intervention groups receive the same amount of tablets (i.e. 30 tablets containing 30 mg elemental iron and 400 µg of folic acid, every month). Monthly IFA utilization will be checked through HEW or our trained service delivery workers during home to home visit. Women who test positive for soil-transmitted helminth will be treated according to the national protocol starting from the second trimester (treatment is not advised during the first trimester). Women who experience odor, itching or discharge will be treated for candidiasis and bacterial vaginosis.
Data will be collected in pregnant women at baseline, at six and at 9 months of pregnancy . After delivery data will be collected in the pairs mother-infant within two weeks and at 3 and 6 months postpartum. At the different time points, biological samples will be collected to assess the micronutrient status, the presence of inflammations and the presence of genital and parasitic infections.
220 studies on the registry are indexed under Vaginosis, Bacterial; 36 are open to participants now.
This study's enrollment of 675 is above the median of 100 across 187 interventional studies indexed under Vaginosis, Bacterial.
Browse Vaginosis, Bacterial studies →University Ghent is the lead sponsor of 345 studies on the registry; 85 are open to participants now.
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Exclusion Criteria:
Pregnant women in the control group will receive the standard education package as per the Ethiopian guidelines. In the standard health care, pregnant women receive a minimum of four ante-natal care visits at the health centers during which they also receive iron and folic acid supplementation. They participate in monthly forums facilitated by nurses to answer questions and concerns regarding nutritional care.
Behavioral: Standard counselling
Women in the Health-Video group will receive home visits for delivery of healthy nutrition messages using prepared video-based messages every two weeks. They will also participate in monthly forums facilitated by nurses using also videos for demonstration of nutritional care. During the monthly forums (six in total during the pregnancy and the post-partum periods), the messages will all be given as a video show coordinated by a nurse/ health professional for any questions. During postnatal period, two counseling sessions will be delivered within two weeks of birth, and 12 sessions or twice every month till 6 months.
Behavioral: Health-Video
The control cohort will receive national standard counseling during four ante-natal care visits. Women in the control group will receive additionally 1. national nutrition and health care including IFA supplementation, 2. treatment of any symptomatic health condition and deworming in case of symptomatic complaints during second and third trimesters, 3. Women who experience odor, itching or discharge will be treated for candidiasis and bacterial vaginosis.
Also known as: Control
The intervention cohort Health-Video will receive innovative video-based nutritional and hygienic education. Women in this group will receive additionally: 1. National nutrition and health care including IFA supplementation 2. treatment of any symptomatic health condition and deworming in case of symptomatic complaints during second and third trimesters, 3. Women who experience odor, itching or discharge will be treated for candidiasis and bacterial vaginosis.
Also known as: Video-based counselling
Adherence to iron and folic acid supplementation during pregnancy
Monthly disappearance rate of IFA tablets
Time frame: Monthly during six months pregnancy
Adherence to iron and folic acid supplementation post-partum
Monthly disappearance rate of IFA tablets
Time frame: Monthly during three months postpartum
Maternal anemia during pregnancy
Hemoglobin concentrations (g/dL)
Time frame: Hemoglobin concentrations will be measured at 9 months pregnancy
Maternal anemia post-partum
Hemoglobin concentrations (g/dL)
Time frame: Hemoglobin concentrations will be measured at six months postpartum
Early initiation
Prevalence of newborns put to the breast in the first hour after birth
Time frame: At birth (six months after the enrollment)
Exclusive breastfeeding
Prevalence of infants exclusively breastfed using maternal reports and the deuterium dose-to-mother technique (in a subgroup)
Time frame: Birth to six months postpartum
Dietary intake during six months pregnancy
Prevalence of women with adequate dietary intake during six months pregnancy
Time frame: Assessed at 6 months and 9 months pregnancy
Dietary intake at six months post-partum
Prevalence of women with adequate dietary intake at six months post-partum
Time frame: Assessed at six months postpartum
Gestational weight gain
Weight gain at term (Kg)
Time frame: Gestational weight gain will be measured in all pregnant women at six and nine months pregnancy
Maternal genital infections
The presence of genital infections that are known to affect a healthy pregnancy, including but not limited to bacterial vaginosis, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Listeria monocytogenes.
Time frame: Maternal genital infections will be assessed at nine months pregnancy
Birth weight
Birth weight (g)
Time frame: Birth weight will be assessed in all newborns
Infant weight
Infant weight (g) on a monthly basis
Time frame: Weight of infants will be assessed monthly from birth until six months of age
Infant length
Infant length (cm) on a monthly basis
Time frame: Length of infants will be assessed monthly from birth until six months of age
Infant anemia
Hemoglobin concentrations (g/dL)
Time frame: Hemoglobin concentrations will be measured at six months of age
Maternal parasitic infections
The presence of worm parasites and egg density in the stools. Three common parasites and their eggs will be investigated, i.e. Ascaris lumbricoides (round worm), Trichuris trichiura (whipworm) and Ancyclostoma duodenale or Necater americanus (hookworms).
Time frame: Worm infections will be assessed in all women at 6 months pregnancy, 9 months pregnancy, and at two weeks- and 6 months post partum
Infant parasitic infections
The prevalence of Giarida and Cryposporidium will be assessed in all infants
Time frame: Infant parasitic infections will be assessed at 6 months of age.
Maternal plasma ferritin
Iron status as indicated plasma ferritin (micro_g/L) is a test to evaluate iron stores
Time frame: Plasma ferritin is assessed in a subgroup of women at 9 months pregnancy and at six months postpartum
Infant plasma ferritin
Iron status as indicated plasma ferritin (micro_g/L) is a test to evaluate iron stores
Time frame: Plasma ferritin is assessed in a subgroup of infants at six months of age
Maternal soluble transferrin receptor
Soluble transferrin receptor (mg/L) is an indicator for iron deficiency especially in high inflammation settings
Time frame: Plasma ferritin is assessed in a subgroup of women at 9 months pregnancy and at six months postpartum
Infant soluble transferrin receptor
Soluble transferrin receptor (mg/L) is an indicator for iron deficiency especially in high inflammation settings
Time frame: Soluble transferrin receptor is assessed in a subgroup of infants at six months of age
Maternal serum concentrations in Vitamin A (retinol)
Retinol concentrations in serum is an indicator of vitamin A status
Time frame: Serum concentrations in Vitamin A are assessed in a subgroup of women at 9 months pregnancy and at six months postpartum
Infant serum concentrations in Vitamin A (retinol)
Retinol concentrations in serum is an indicator of vitamin A status
Time frame: Serum concentrations in Vitamin A are assessed in a subgroup of infants at six months of age
Maternal serum concentrations in vitamin B12
Serum concentrations in vitamin B12
Time frame: Vitamin B12 concentrations will be assessed in a subgroup of women at 9 months pregnancy and at six months postpartum
Infant serum concentrations in vitamin B12
Serum concentrations in vitamin B12
Time frame: Vitamin B12 concentrations will be assessed in a subgroup of infants at six months of age
Plan to share: No — All the data that can affect the main or the secondary outcomes will be used in the analyses and shared as necessary. Data on helminthic infection will use household characteristics and women and infants nutritional status
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