Fetal Growth Retardation Clinical Trial
Official title:
DEUX OEUFs:Cracking the Potential of Eggs to Improve Child Growth and Development
This proposed randomized controlled trial aims to investigate the effect of maternal egg consumption during pregnancy on birth length. The study hypothesizes that mothers who consume two eggs a day will have children whose birth length is significantly longer than those born to mothers who consume a typical diet. Pregnant women (n=956) from Nyagatare District in Rwanda will be randomized into one of two study arms: a treatment group (T1) or a control group (T2). Mothers in the treatment arm will receive an animal source food (ASF) supplement of two eggs per day, from enrollment during first trimester through childbirth. Mothers in the control arm will be asked to continue consuming their typical diet. Mothers in both arms will receive standard information, education, and communication about health and nutrition during pregnancy and after birth. All enrolled mothers in the study will also receive up- to-date standard care for pregnant women, as outlined by the Government of Rwanda, a fortified blended flour if they are not already receiving it from the government, a mobile phone with cellular connection, health insurance if they do not already have, and compensation for traveling to a Community Health Worker's home every day for study engagement. All women will receive ultrasound examinations three times during pregnancy, as well as blood tests for anemia. Women in the control arm will receive additional compensation at childbirth. Women will be recruited and enrolled during first trimester (9-14 weeks gestational age), as confirmed by ultrasound. At enrollment, baseline data will be collected on socio-economic factors, maternal health, maternal diet, and fetal growth. Additional markers for maternal health and child growth and development, including markers for fetal brain development, will be collected during two targeted ante-natal clinic visits (20-26 weeks and 30-34 weeks), where all women will receive ultrasound assessment in addition to their typical clinical assessment. At childbirth, maternal and child health data will be collected, including birth outcomes, child anthropometry, and indicators of neurodevelopment. Additional follow-up of maternal and child health indicators, including maternal depression, and infant and young child feeding practices, will be collected at 1 month and 6 months of child age.
Status | Recruiting |
Enrollment | 1912 |
Est. completion date | March 30, 2026 |
Est. primary completion date | September 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 44 Years |
Eligibility | Inclusion Criteria: - Lives in study area (catchment area of Karangazi Health Center and Ndama Health Center) - Confirmed viable intrauterine pregnancy (confirmed via ultrasound) - Aged between 18-44 years - 9-14 weeks gestation (confirmed via ultrasound, up to 13 weeks +6 days) - Agrees to participate with informed consent Exclusion Criteria: - Intention to move outside the study area in next 12 months - Intention to deliver at a location outside of Eastern Province Nyagatare District - Any known adverse reaction to eating eggs or porridge ingredients - Any condition that could affect the ability to comply with the study requirements or understand the informed consent process - Participation in other clinical trials (to avoid burden and potential interactions between interventions) - Any individual unable or unwilling to comply with the study requirements, such as attending regular follow-up visits or adhering to prescribed nutritional supplementation. |
Country | Name | City | State |
---|---|---|---|
Rwanda | Ndama Health Center | Nyagatare |
Lead Sponsor | Collaborator |
---|---|
University of Florida | University of Rwanda, World Vision |
Rwanda,
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* Note: There are 34 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Thalamus length | Thalamic measurements in cm, based on ultrasound | Between 20-26 weeks and 30-34 weeks gestational ages | |
Other | Thalamus width | Thalamic measurements in cm, based on ultrasound | Between 20-26 weeks and 30-34 weeks gestational ages | |
Other | Thalamus transverse | Thalamic measurements in cm, based on ultrasound | Between 20-26 weeks and 30-34 weeks gestational ages | |
Other | All-5 (indicator of eating all five food groups) | Dietary Quality Questionnaire will be used to generate the All-5; range 0-5, where 5=1 and les than 5 = 0 (higher score, better outcome) | Between 9-<14 weeks, 20-26 weeks, and 30-34 weeks gestational ages, and at 1 and 6 months post birth | |
Other | Animal Source Food Consumption | Dietary Quality Questionnaire will be used to generate an indicator of animal source food consumption (milk, meat, eggs, fish), used here to generate a score (0-4), 4 is better. | Between 9-<14 weeks, 20-26 weeks, and 30-34 weeks gestational ages, and at 1 and 6 months post birth | |
Other | Child motor development | Measured according to the Caregiver Reported Early Childhood Development Instrument (CREDI) Score, domain-specific motor development | 6 months of age | |
Other | Child cognitive development | Measured according to the Caregiver Reported Early Childhood Development Instrument (CREDI) Score, domain-specific cognitive development | 6 months of age | |
Other | Child social-emotional development | Measured according to the Caregiver Reported Early Childhood Development Instrument (CREDI) Score, domain-specific social-emotional development | 6 months of age | |
Other | Child language development | Measured according to the Caregiver Reported Early Childhood Development Instrument (CREDI) Score, domain-specific language development | 6 months of age | |
Primary | Newborn Length for age z-score | Child's recumbent length at birth, standardized using the INTERGROWTH 21st growth standard | Within 72 hours of birth | |
Secondary | Head circumference Z-scores | Ultrasound derived estimate of head circumference in cm (standardized using the INTERGROWTH 21st growth standards) | Between 20-26 weeks and 30-34 weeks gestational ages | |
Secondary | Femur length Z-scores | Ultrasound derived measure of femur length in cm (standardized using the INTERGROWTH 21st growth standards) | Between 20-26 weeks and 30-34 weeks gestational ages | |
Secondary | Abdominal circumference Z-scores | Ultrasound derived measure of abdominal circumference in cm (standardized using the INTERGROWTH 21st growth standards) | Between 20-26 weeks and 30-34 weeks gestational ages | |
Secondary | Biparietal Z-scores | Ultrasound derived biparietal diameter in cm (standardized using the INTERGROWTH 21st growth standards) | Between 20-26 weeks and 30-34 weeks gestational ages | |
Secondary | Estimated fetal weight Z-scores | Ultrasound derived fetal weight in g (standardized using the INTERGROWTH 21st growth standards) | Between 20-26 weeks and 30-34 weeks gestational ages | |
Secondary | Cerebellar diameter | Cerebellar diameter (axial plane) in cm, based on ultrasound | Between 20-26 weeks and 30-34 weeks gestational ages | |
Secondary | Corpus callosum length | Corpus callosum length in cm, based on ultrasound | Between 20-26 weeks and 30-34 weeks gestational ages | |
Secondary | Thalamus midline axial | Thalamic measurements in cm, based on ultrasound | Between 20-26 weeks and 30-34 weeks gestational ages | |
Secondary | Gangliothalamic ovoid diameter | Gangliothalamic ovoid diameter in cm, based on ultrasound | Between 20-26 weeks and 30-34 weeks gestational ages | |
Secondary | Gangliothalamic ovoid sagittal length | Gangliothalamic ovoid sagittal length in cm, based on ultrasound | Between 20-26 weeks and 30-34 weeks gestational ages | |
Secondary | Gangliothalamic ovoid estimated volume | Gangliothalamic ovoid estimated volume cubic cm, based on ultrasound | Between 20-26 weeks and 30-34 weeks gestational ages | |
Secondary | Gestational duration | Gestational age in weeks at birth (among live births) | At birth of newborn | |
Secondary | Preterm birth | Proportion of live births <37 weeks completed gestation | At birth of newborn | |
Secondary | Birthweight | Birthweight (g) among live births | Within 72 hours of birth | |
Secondary | Low birthweight | Proportion of live births that are low birthweight (<2500 g) | Within 72 hours of birth | |
Secondary | Birthweight for gestational age | Birth weight-for-age z-score according to INTERGROWTH 21st growth standards | Within 72 hours of birth | |
Secondary | Small for Gestational Age (SGA) at birth | Birthweight for gestational age at birth (10th percentile and 3rd percentile), according to INTERGROWTH 21st growth standards) | Within 72 hours of birth | |
Secondary | Small vulnerable newborn status among live births | Defined as SGA (10th percentile) according to INTERGROWTH 21st growth standards, preterm birth (<37 weeks completed gestation), or low birth weight <2500g | Within 72 hours of birth | |
Secondary | Newborn developmental assessment | Hammersmith Neonatal Neurological Examination (HNNE) | At one month of age | |
Secondary | Head circumference of newborn | Head circumference and head circumference z-score according to INTERGROWTH 21st growth standard | Within 72 hours of birth | |
Secondary | Maternal weight | Maternal weight in kg | Weight will be collected at enrolment (between 9-<14 weeks gestation), 20-26 weeks gestation, 30-34 weeks gestation, and during labor/delivery | |
Secondary | Maternal weight gain during pregnancy | Designation of inadequate, adequate, and excessive weight gain according to IOM guidelines and calculated based on maternal weight at labor/delivery visit - maternal weight at enrolment. | Weight will be collected at enrolment (between 9-<14 weeks gestation), 20-26 weeks gestation, 30-34 weeks gestation, and during labor/delivery | |
Secondary | Maternal cortisol concentration | Cortisol concentration from maternal hair and/or nail samples (per participant preference) | Between 9-<14 weeks, 20-26 weeks, and 30-34 weeks gestational ages, at time of birth, and at 1 and 6 months post birth | |
Secondary | Minimum Dietary Diversity for Women | Dietary Quality Questionnaire will be used to generate the MDD-W, used here as meeting the validated threshold or not 0-10 scale, higher is more diversity (better) with threshold of having at least 5 to have met minimum requirements (coded as 0 for not having met/1 for have met MDD) | Between 9-<14 weeks, 20-26 weeks, and 30-34 weeks gestational ages, and at 1 and 6 months post birth | |
Secondary | Dietary Diversity Score | Dietary Quality Questionnaire will be used to generate the MDD-W, used here to generate a score (0-10), where 10 is highest dietary diversity | Between 9-<14 weeks, 20-26 weeks, and 30-34 weeks gestational ages, and at 1 and 6 months post birth | |
Secondary | Maternal Hemoglobin | We will measure hemoglobin, as indicated by trimester specific WHO cutoffs. | Between 9-<14 weeks, 20-26 weeks, and 30-34 weeks gestational ages, at time of birth, and at 1 and 6 months post birth | |
Secondary | Maternal depression | Edinburgh Postnatal Depression Scale (range 0-30; 12 or higher defining maternal depression) | At 6 weeks and 6 months post birth | |
Secondary | Infant Length-for-age z-score | Length-for-age z-score according to the WHO Multicentre Growth Reference Study standard | At 6 weeks and 6 months of age | |
Secondary | Prevalence of Stunting among infants | Length-for-age z-score <-2 SD of the median according to the WHO Multicentre Growth Reference Study standard | At 6 weeks and 6 months of age | |
Secondary | Infant weight-for-age Z score | Weight-for-age Z score according to WHO standard | At 6 weeks and 6 months of age | |
Secondary | Prevalence of Underweight among infants | Weight-for-age z-score <-2 SD of the median according to the WHO Multicentre Growth Reference Study standard | At 6 weeks and 6 months of age | |
Secondary | Child neurodevelopment | Measured according to the Caregiver Reported Early Childhood Development Instrument (CREDI) Score (Long Form) | 6 months of age | |
Secondary | Biomarkers of micronutrient status, growth factors, systemic inflammation, environmental enteric dysfunction, metabolomics, choline, lipid panel (including HDL and LDL cholesterol) | Measured using whole blood or serum samples among women and infants | Between 9-<14 weeks, 20-26 weeks, and 30-34 weeks gestational ages, at time of birth, and at 1 and 6 months post birth | |
Secondary | Maternal blood pressure | Diastolic and systolic blood pressure will be measured during pregnancy. | Between 9-<14 weeks, 20-26 weeks, and 30-34 weeks gestational ages, at time of birth, and at 1 and 6 months post birth |
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