Actively Recruiting
The MOM-CARE Trial : Evaluating Antenatal and Postnatal MMSPlus for Improved Infant Birth and Growth Outcomes
Led by Aga Khan University · Updated on 2025-10-07
3000
Participants Needed
1
Research Sites
129 weeks
Total Duration
On this page
Sponsors
A
Aga Khan University
Lead Sponsor
V
Vital Pakistan Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The MOM-CARE Trial : Evaluating Antenatal and Postnatal MMSPlus for Improved Infant Birth and Growth Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gestational age confirmed by ultrasound to be 8-14 weeks
- Singleton and viable fetus on ultrasound
- Resident of the catchment area for at least the last six months
- Plans to stay within the catchment area during pregnancy, delivery, and after birth
- Has provided voluntary written informed consent
- Birth weight available within 72 hours
- Intends to breastfeed exclusively for 6 months
- Resides in the study area for the duration of the trial
- Has provided voluntary written informed consent
You will not qualify if you...
- Known allergies or intolerance to any components of MMS or MMS Plus being studied
- History of uncontrolled diabetes, hypertension, or other chronic illnesses
- Substance abuse such as recreational drugs or smoking tobacco (chewing tobacco allowed)
- Congenital anomalies, birth defects, or severe neonatal complications
- Infants already receiving supplemental formula feeding or other nutritional supplements (except pre-lacteal feeding, vitamins, and medications)
- Mothers with conditions significantly affecting breastfeeding, such as severe postpartum depression, insufficient milk supply, or use of medications contraindicating breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peri-Urban Slums of Karachi (Ali Akber Shah, Bhains Colony)
Karachi, Sindh, Pakistan
Actively Recruiting
Research Team
F
Fyezah Jehan, MBBS; MSc
CONTACT
Z
Zahra Hoodbhoy, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
PREVENTION
Number of Arms
3
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