The MOM-CARE Trial : Evaluating Antenatal and Postnatal MMSPlus for Improved Infant Birth and Gro… (NCT07029282) | Clinical Trial Compass
RecruitingPhase 3
The MOM-CARE Trial : Evaluating Antenatal and Postnatal MMSPlus for Improved Infant Birth and Growth Outcomes
Pakistan3,000 participantsStarted 2025-07-08
Plain-language 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.
Who can participate
Age range
15 Years – 49 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Antenatal Phase: Composite Infant Health Score at 28 Days Post-Birth
Timeframe: 28 days after birth
2
Postnatal Phase: Infant linear growth velocity at 6 months