MOM-CARE: enhanced micronutrient supplements during and after pregnancy to help babies be born healthier and grow better
A Phase III Double-Blind, Adaptive Randomized Trial of Antenatal MMSPlus Versus UNIMAPP MMS and Postnatal MMSPlus Versus UNIMAPP MMS or IFA to Improve Infant Birth Outcomes and Growth at 6 Months
This will test whether an enhanced multivitamin supplement (MMS Plus) given during pregnancy and after birth helps babies born to women in peri-urban Karachi have better birth outcomes and faster early growth than standard MMS or iron/folic acid.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 3000 (estimated) |
| Ages | 15 Years to 49 Years |
| Sex | Female |
| Sponsor | Aga Khan University Academic / other |
| Locations | 1 site (Karachi, Sindh) |
| Trial ID | NCT07029282 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal participants are pregnant women 8–14 weeks by ultrasound, with a singleton viable pregnancy, who live in the peri-urban Karachi catchment area and plan to remain there through delivery and the follow-up period.
Not a fit: Women with uncontrolled chronic illnesses, known allergies to supplement components, those not planning to breastfeed, or those who cannot remain in the study area are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, MMS Plus could lower newborn mortality or growth-related problems and help infants gain length more rapidly in the first six months.
How similar studies have performed: Previous trials of standard MMS formulations (UNIMMAP) have shown modest improvements in some birth outcomes, but enhanced formulations like MMS Plus are relatively novel and have not been widely proven in large Phase 3 trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Karachi, Sindh
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.