MOM-CARE: enhanced micronutrient supplements during and after pregnancy to help babies be born healthier and grow better

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

MOM-CARE is a double-blind, adaptive, randomized Phase 3 trial that compares an enhanced multiple micronutrient formulation (MMS Plus) with standard UNIMMAP MMS during pregnancy and with MMS or iron/folic acid (IFA) after birth. Pregnant women at 8–14 weeks' gestation are randomized antenatally to MMS Plus or standard MMS, and those with live births are re-randomized postpartum into MMS Plus, standard MMS, or IFA. The antenatal primary outcome is a 5-point composite ordinal measure of infant outcome at 28 days (ranging from perinatal death to term birth with varying growth-for-gestational-age categories) and the postnatal primary outcome is infant length velocity at 6 months among exclusively breastfed infants. The trial uses Bayesian adaptive interim analyses to allow early stopping for superiority or continued evaluation, and it is conducted in peri-urban Karachi by Aga Khan University.

Why it matters

Who can join: the full rules

Antenatal Phase::

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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's running

• Peri-Urban Slums of Karachi (Ali Akber Shah, Bhains Colony)
  Karachi, Sindh, Pakistan Recruiting

Study contacts

• Principal investigator: Fyezah Jehan, MBBS; MSc — Aga Khan University
• Study coordinator: Fyezah Jehan, MBBS; MSc
• Email: fyezah.jehan@aku.edu
• Phone: +9234930051

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.