NCT07029282 The MOM-CARE Trial : Evaluating Antenatal and Postnatal MMSPlus for Improved Infant Birth and Growth Outcomes
| NCT ID | NCT07029282 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Aga Khan University |
| Condition | Newborn Health |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2025-07-08 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 3,000 participants in total. It began in 2025-07-08 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Fyezah Jehan, MBBS; MSc
PRINCIPAL INVESTIGATOR
Aga Khan University
Frequently Asked Questions
Who can join the NCT07029282 clinical trial?
This trial is open to female participants only, aged 15 Years or older, up to 49 Years, studying Newborn Health. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07029282 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 3,000 participants.
Is NCT07029282 currently recruiting?
Yes, NCT07029282 is actively recruiting participants. Contact the research team at fyezah.jehan@aku.edu for enrollment information.
Where is the NCT07029282 trial being conducted?
This trial is being conducted at Karachi, Pakistan.
Who is sponsoring the NCT07029282 clinical trial?
NCT07029282 is sponsored by Aga Khan University. The principal investigator is Fyezah Jehan, MBBS; MSc at Aga Khan University. The trial plans to enroll 3,000 participants.