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

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.

Conditions

• Neurodevelopment Outcome
• Newborn Health
• Multiple Micronutrient Deficiencies During Pregnancy
• Nutrition During Pregnancy
• Adaptive Trial
• Postnatal Growth

Interventions

DIETARY_SUPPLEMENT

MMS

Pregnant women in this arm will receive 6gms of MMS (UNIMAPP MMS) in a ready to use sachet form which includes 15 nutrients.

DRUG

MMS Plus

Pregnant women in this arm will receive 6gms of MMS Plus in a ready to use sachet form which includes 18 nutrients.

DIETARY_SUPPLEMENT

IFA

Pregnant women in this arm will receive 6gms of IFA (Iron/Folic Acid) in a ready to use sachet form which includes 2 nutrients.

Sponsors & Collaborators

• Vital Pakistan Trust

  collaborator OTHER

• Aga Khan University

  lead OTHER

Principal Investigators

• Fyezah Jehan, MBBS; MSc · Aga Khan University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

15 Years

Max Age

49 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-07-08

Primary Completion

2027-06-30

Completion

2027-12-31

Countries

• Pakistan

Study Locations