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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
6,750
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.
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.
In Arm 4 (universal BEP), all participants will receive BEP supplements from baseline through the end of pregnancy.
Addis Continental Institute of Public Health (ACIPH)
Addis Ababa, Addis Ababa, Ethiopia
RECRUITINGSmall-for-gestational-age births
Live birth whose birthweight for sex and gestational age is \< 10th percentile based on the INTERGROWTH-21st standards
Time frame: Assessed within 72 hours of birth
Inadequate gestational weight gain
Gestational weight gain percent adequacy ratio less than 90% at the last weight measurement before delivery, based on the Institute of Medicine recommendations
Time frame: At the last weight measurement before delivery, at around 36 weeks
Excessive gestational weight gain
Gestational weight gain percent adequacy ratio greater than 125% at the last weight measurement before delivery, based on the Institute of Medicine recommendations
Time frame: At the last weight measurement before delivery, at around 36 weeks
Stillbirth
Fetal death between 28 weeks of gestation and delivery
Time frame: Between 28 weeks of gestation and delivery
Preterm birth
Live birth \< 37 completed weeks of gestation
Time frame: Less than 37 completed weeks of gestation
Low birthweight
Live birth weighing \< 2500 grams
Time frame: Assessed within 72 hours of birth
Macrosomia
Live birth weighing \> 4000 grams
Time frame: Assessed within 72 hours of birth
Large-for-gestational-age births
Live birth whose birthweight for sex and gestational age is \> 90th percentile based on the INTERGROWTH-21st standards
Time frame: Assessed within 72 hours of birth
Third-trimester anemia
Hemoglobin concentration \< 11 g/dL at 32 weeks of gestation
Time frame: At 32 weeks of gestation
Neonatal death
Death of live newborn \< 28 days of life
Time frame: From birth through 28 days of life
Perinatal death
Fetal death between 28 weeks gestational age and delivery, or newborn death \< 7 days of life
Time frame: Between 28 weeks of gestation to 7 days after delivery
Pre-eclampsia
New onset hypertension (systolic blood pressure \>= 140 or diastolic blood pressure \>=90 mmhg) after 20 weeks of gestation with proteinuria.
Time frame: After 20 weeks of gestation
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