Table 1.
Summary information for each randomized controlled trial or effectiveness study in the Maternal BEP Studies Harmonization Initiative
Full study name | Short name | Country | Study design | Life stages receiving BEP | Enrollment @ life stage | Registry | Principal Investigators |
---|---|---|---|---|---|---|---|
Enhancing Nutrition and Antenatal Infection Treatment for Maternal and Child Health | ENAT | Ethiopia | Cluster (health center) and individual (within health center) randomizationa | Pregnancy | ~ 2400 @ < 24 weeks gestation |
ISRCTN registry ISRCTN15116516 |
Anne CC Lee; Yemane Berhane |
IMPRINTb | IMPRINT | India | Individual randomization | Lactation | 816 @ < 1 week after delivery | Clinical Trials Registry-India CTRI/2018/04/013095 | Sunita Taneja |
Mothers and Infants Nutrition Trial | MINT | Nepal | Individual randomization | Pregnancy | 900 @ early pregnancy | ClinicalTrials.gov NCT03668977 | James Tielsch |
MIcronutriments pour la SAnté de la Mère et de l’Enfant III | MISAME-III | Burkina Faso | Individual randomization with factorial designc |
Pregnancy Lactation |
1788 @ early pregnancy | ClinicalTrials.gov NCT03533712 | Patrick Kolsteren |
Mumta Pregnant Women Trial | MumtaPW | Pakistan | Individual randomization | Pregnancy | 1836 @ pregnancy | ClinicalTrials.gov NCT04012177 | Yasir Shafiq; Ameer Muhammad |
Mumta Lactating Women Trial | MumtaLW | Pakistan | Individual randomization | Lactation | 957 @ < 1 week after delivery | ClinicalTrials.gov NCT03564652 | Yasir Shafiq; Ameer Muhammad |
Women and Infants Integrated Interventions for Growth Study | WINGS | India | Individual randomization with factorial designc |
Preconception Pregnancy Lactation |
13,500 @ preconception |
Clinical Trials Registry-India CTRI/2017/06/008908 |
Nita Bhandari |
BEP balanced energy-protein
aPragmatic clinical effectiveness study
bAdded to Harmonization Initiative in October 2020
cFactorial design for MISAME-III was random assignment for pregnancy and random assignment for postpartum; factorial design for WINGS was random assignment for preconception and random assignment for pregnancy (women were also stratified by height at enrollment)