[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adaptive-trial\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adaptive-trial":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":35,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":5},"100595194","phase-3-the-mom-care-trial--evaluating-antenatal-and-postnatal-mmsplus-for-improved-infant-birth-and-growth-outcomes-100595194",false,"NCT07029282","The MOM-CARE Trial : Evaluating Antenatal and Postnatal MMSPlus for Improved Infant Birth and Growth Outcomes","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","MOM-CARE","Antenatal Phase::\n\nInclusion Criteria:\n\n* Gestational age confirmed by ultrasound to be 8-14 weeks\n* Singleton and viable fetus on ultrasound\n* A resident of the catchment area for at least the last six months\n* Plans to stay within the catchment area during the pregnancy duration, during delivery and after birth of the baby.\n* Has provided voluntary written informed consent\n\nExclusion Criteria:\n\n* Women with known allergies or intolerance to any components of the MMS or MMS PLUS being studied\n* Women with pre-existing health conditions such as history of uncontrolled diabetes and hypertension or other chronic illnesses\n* Substance abuse, such as recreational drugs or smoking tobacco. Women chewing tobacco will not be excluded.\n\nPostnatal Phase::\n\nInclusion Criteria:\n\n* Birth weight available within 72 hours\n* Intention to breastfeed for 6 months\n* Resides in the study area for the duration of the trial\n* Has provided voluntary written informed consent\n\nExclusion Criteria:\n\n* Congenital anomalies, birth defects, or severe neonatal complications\n* Infants who are already receiving supplemental formula feeding or other nutritional supplements (except pre-lacteal feeding, vitamins, and medications)\n* 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",true,"FEMALE","15 Years","49 Years",{"count":22,"type":23},3000,"ESTIMATED","INTERVENTIONAL",[26],"PHASE3","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.\n\nThe main questions it aims to answer are:\n\n1. 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?\n2. Does postnatal MMS Plus improve infant length velocity at 6 months of age among exclusively breastfed infants compared to standard MMS and iron\u002Ffolic acid (IFA) supplementation?\n\nResearchers will compare:\n\n1. MMS Plus versus standard MMS during pregnancy (antenatal phase)\n2. MMS Plus versus standard MMS versus IFA after birth (postnatal phase)\n\nParticipants will:\n\n1. Be randomly assigned to receive either MMS Plus or standard MMS during pregnancy\n2. Be re-randomized after delivery to receive either MMS Plus, standard MMS, or IFA supplements during the postnatal period\n3. Receive supplements under double-blind conditions\n4. Be followed through childbirth and until the infant is 6 months of age\n5. Attend regular clinic visits for health monitoring, infant assessments, and data collection.\n\nThis phase III adaptive randomized controlled trial will occur in three peri-urban catchment areas of Karachi, Pakistan.",[29,30,31,32,33,34],"Newborn Health","Multiple Micronutrient Deficiencies During Pregnancy","Nutrition During Pregnancy","Adaptive Trial","Postnatal Growth","Neurodevelopment Outcome",[36,37,38,39],"Antenatal Phase","Postnatal Phase","Micro Nutrient Supplementation","Infant Growth","RECRUITING","2025-10-01",{"date":43,"type":44},"2025-10-07","ACTUAL",{"date":46,"type":44},"2025-07-08",{"date":48,"type":23},"2027-12-31",{"name":50,"class":51},"Aga Khan University","OTHER"]