A Phase III Double-Blind, Adaptive Randomized Trial of Antenatal MMS Plus Versus UNIMMAP MMS and Postnatal MMS Plus Versus UNIMMAP MMS or IFA to Improve Infant Birth Outcomes and Growth at 6 Months

What this Trial Is About

Researchers are evaluating whether an enhanced multiple micronutrient supplement called MMS Plus improves infant health and growth compared to standard MMS and iron/folic acid (IFA) supplements during pregnancy and after birth. The study focuses on women living in peri-urban areas of Karachi, Pakistan, aiming to reduce poor infant outcomes and improve infant length growth during the first six months of life. This Phase III adaptive randomized controlled trial uses a double-blind design to compare these supplements across two phases. During the antenatal phase, pregnant women between 8 and 14 weeks gestation are randomly assigned to receive either MMS Plus or standard MMS daily, along with standard antenatal care and nutrition counseling. After delivery, women with live births are re-randomized to receive MMS Plus, standard MMS, or IFA supplements daily for the postnatal period, with continued nutrition counseling and care. All supplements are provided in identical sachets to maintain blinding. The trial is conducted in three peri-urban communities with high maternal undernutrition. Participants attend clinic and home visits from enrollment through six months postpartum for health monitoring and infant assessments. Researchers collect data on infant outcomes such as a composite health score at 28 days, infant length growth velocity at six months, and secondary measures including birth weight, head circumference, and neurodevelopmental assessments. Supplement adherence is tracked digitally, and safety is monitored by an independent board. The total participation duration covers pregnancy through the infant's first six months.

The MOM-CARE Trial : Evaluating Antenatal and Postnatal MMSPlus for Improved Infant Birth and Growth Outcomes