The MOM-CARE Trial : Evaluating Antenatal and Postnatal MMSPlus for Improved Infant Birth and Growth Outcomes
Recruiting now · Phase 3
Conditions studied: Newborn Health, Multiple Micronutrient Deficiencies During Pregnancy, Nutrition During Pregnancy, Adaptive Trial, Postnatal Growth, Neurodevelopment Outcome
In brief
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.
Key facts
- Study ID
- NCT07029282
- Run by
- Aga Khan University
- People needed
- 3000
- Starts
- 2025-07-08
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2025-10-07
Who can join
Age: 15 and older, up to 49. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Gestational age confirmed by ultrasound to be 8-14 weeks
- Singleton and viable fetus on ultrasound
- A resident of the catchment area for at least the last six months
- Plans to stay within the catchment area during the pregnancy duration, during delivery and after birth of the baby.
- Has provided voluntary written informed consent
You may not qualify if…
- Women with known allergies or intolerance to any components of the MMS or MMS PLUS being studied
- Women with pre-existing health conditions such as history of uncontrolled diabetes and hypertension or other chronic illnesses
- Substance abuse, such as recreational drugs or smoking tobacco. Women chewing tobacco will not be excluded.
- Postnatal Phase::
- Inclusion Criteria:
- Birth weight available within 72 hours
- Intention to breastfeed for 6 months
- Resides in the study area for the duration of the trial
- Has provided voluntary written informed consent
- Exclusion Criteria:
- Congenital anomalies, birth defects, or severe neonatal complications
- Infants who are already receiving supplemental formula feeding or other nutritional supplements (except pre-lacteal feeding, vitamins, and medications)
- Infants whose mothers have conditions that significantly affect breastfeeding, such as severe postpartum depression, insufficient milk supply, or maternal use of medications that contraindicate breastfeeding
Where it is running
- Peri-Urban Slums of Karachi (Ali Akber Shah, Bhains Colony) — Karachi, Sindh, Pakistan (enrolling)
Full record on ClinicalTrials.gov
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