The MOM-CARE Trial : Evaluating Antenatal and Postnatal MMSPlus for Improved Infant Birth and Growth Outcomes
Status:
RECRUITING
Trial end date:
2027-12-31
Target enrollment:
Participant gender:
Summary
This clinical trial aims to learn if MMS Plus improves infant health compared to standard MMS during pregnancy and the postnatal period in women living in peri-urban areas of Karachi, Pakistan. It will also evaluate how MMS Plus affects infant growth during the first 6 months of life.
The main questions it aims to answer are:
1. Does MMS Plus during pregnancy reduce the risk of poor infant outcomes compared to standard MMS, as measured on a 5-point ordinal scale ranging from perinatal mortality to term birth with appropriate, small, or large-for-gestational-age infants?
2. Does postnatal MMS Plus improve infant length velocity at 6 months of age among exclusively breastfed infants compared to standard MMS and iron/folic acid (IFA) supplementation?
Researchers will compare:
1. MMS Plus versus standard MMS during pregnancy (antenatal phase)
2. MMS Plus versus standard MMS versus IFA after birth (postnatal phase)
Participants will:
1. Be randomly assigned to receive either MMS Plus or standard MMS during pregnancy
2. Be re-randomized after delivery to receive either MMS Plus, standard MMS, or IFA supplements during the postnatal period
3. Receive supplements under double-blind conditions
4. Be followed through childbirth and until the infant is 6 months of age
5. Attend regular clinic visits for health monitoring, infant assessments, and data collection.
This phase III adaptive randomized controlled trial will occur in three peri-urban catchment areas of Karachi, Pakistan.