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

RecruitingPhase 3Ages 15 Years - 49 YearsFemaleAga Khan University
NCT07029282 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 af

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📋 Eligibility rules (as published)
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
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What it tests

  • MMS
  • MMS Plus
  • IFA
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Where

1 site
Peri-Urban Slums of Karachi (Ali Akber Shah, Bhains Colony)
Karachi, Pakistan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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