Birth Weight, Gestational Weight Gain, Maternal Anemia in Pregnancy, Before Birth, Neonatal Death, Perinatal Death, Preterm Birth, Small for Gestational Age at Delivery, Stillbirth
Conditions
Keywords
balanced energy and protein supplementation, food supplementation, antenatal nutrition, maternal nutrition, gestational weight gain, Ethiopia
Brief summary
The goal of this randomized effectiveness study is to evaluate the different targeting strategies for the delivery of balanced energy and protein (BEP) supplements among pregnant women in Addis Ababa, Ethiopia. The main goals of the study are to: 1) determine the effectiveness of two individual-based antenatal BEP targeting strategies for preventing adverse pregnancy outcomes; 2) compare the cost-effectiveness of the universal BEP provision with two individual-based targeting strategies for preventing adverse pregnancy outcomes; and 3) generate implementation evidence regarding the feasibility and acceptability of different antenatal BEP targeting strategies. Pregnant women will be enrolled during pregnancy, assigned to different strategies of BEP supplementation, and followed from pregnancy through six weeks postpartum to evaluate the impacts of different BEP targeting strategies on pregnancy, maternal, and child outcomes.
Interventions
DIETARY_SUPPLEMENTTargeted BEP based on baseline nutritional status
In Arm 2 (targeted BEP based on baseline nutritional status), in addition to the standard of care, participants will receive BEP supplements if their baseline BMI is less than 18.5 or their baseline mid-upper arm circumference is less than 23 cm.
DIETARY_SUPPLEMENTTargeted BEP based on baseline nutritional status and monthly GWG monitoring
In Arm 3 (targeted BEP based on baseline nutritional status and monthly GWG monitoring), in addition to the standard of care, participants will receive BEP supplements if their baseline BMI is less than 18.5 or their baseline mid-upper arm circumference is less than 23 cm; participants with an inadequate GWG at a monthly follow-up visit will receive additional BEP supplements.
DIETARY_SUPPLEMENTUniversal BEP
In Arm 4 (universal BEP), all participants will receive BEP supplements from baseline through the end of pregnancy.
Sponsors
Harvard School of Public Health (HSPH)
Addis Continental Institute of Public Health
George Mason University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
1. pregnant women aged 18 to 49; 2. attending antenatal visits in one of the study health facilities; 3. with a gestational age of 24 weeks or less; 4. no known allergies to peanuts or soybeans; 5. having resided in the current location for at least 6 months; 6. intending to continue antenatal follow-up in the health facility; 7. intending to give birth and remain in the study area until six weeks after delivery; and 8. willing to take the BEP supplements for the entire duration of the pregnancy if eligible.
Exclusion criteria
* Not meeting all of the inclusion criteria above
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Small-for-gestational-age births | Assessed within 72 hours of birth | Live birth whose birthweight for sex and gestational age is \< 10th percentile based on the INTERGROWTH-21st standards |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inadequate gestational weight gain | At the last weight measurement before delivery, at around 36 weeks | Gestational weight gain percent adequacy ratio less than 90% at the last weight measurement before delivery, based on the Institute of Medicine recommendations |
| Excessive gestational weight gain | At the last weight measurement before delivery, at around 36 weeks | Gestational weight gain percent adequacy ratio greater than 125% at the last weight measurement before delivery, based on the Institute of Medicine recommendations |
| Stillbirth | Between 28 weeks of gestation and delivery | Fetal death between 28 weeks of gestation and delivery |
| Preterm birth | Less than 37 completed weeks of gestation | Live birth \< 37 completed weeks of gestation |
| Low birthweight | Assessed within 72 hours of birth | Live birth weighing \< 2500 grams |
| Macrosomia | Assessed within 72 hours of birth | Live birth weighing \> 4000 grams |
| Large-for-gestational-age births | Assessed within 72 hours of birth | Live birth whose birthweight for sex and gestational age is \> 90th percentile based on the INTERGROWTH-21st standards |
| Third-trimester anemia | At 32 weeks of gestation | Hemoglobin concentration \< 11 g/dL at 32 weeks of gestation |
| Neonatal death | From birth through 28 days of life | Death of live newborn \< 28 days of life |
| Perinatal death | Between 28 weeks of gestation to 7 days after delivery | Fetal death between 28 weeks gestational age and delivery, or newborn death \< 7 days of life |
| Pre-eclampsia | After 20 weeks of gestation | New onset hypertension (systolic blood pressure \>= 140 or diastolic blood pressure \>=90 mmhg) after 20 weeks of gestation with proteinuria. |
Countries
Ethiopia
Contacts
PRINCIPAL_INVESTIGATORWafaie W Fawzi, DrPH, MBBS
Harvard School of Public Health (HSPH)
PRINCIPAL_INVESTIGATORYemane Berhane, MD, PhD
Addis Continental Institute of Public Health
Outcome results
None listed