[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595194":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":44,"locations":53,"responsibleParty":80,"collaborators":82,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":36,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":111,"overallStatus":56,"whyStopped":36,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Aga Khan University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"MMS","ACTIVE_COMPARATOR","Once daily dose of MMS sachet + Standard ANC and nutrition counseling",[13],"Dietary Supplement: MMS",{"label":15,"type":10,"description":16,"interventionNames":17},"IFA","Once daily dose of IFA sachet + Standard postnatal care (PNC) and nutrition counseling",[18],"Dietary Supplement: IFA",{"label":20,"type":21,"description":22,"interventionNames":23},"MMS Plus","EXPERIMENTAL","One daily sachet of MMS PLUS + Standard ANC and nutrition counseling",[24],"Drug: MMS Plus",[26,32,37],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"DIETARY_SUPPLEMENT","Pregnant women in this arm will receive 6gms of MMS (UNIMAPP MMS) in a ready to use sachet form which includes 15 nutrients.",[9],[31],"UNIMAPP MMS",{"type":33,"name":20,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Pregnant women in this arm will receive 6gms of MMS Plus in a ready to use sachet form which includes 18 nutrients.",[20],null,{"type":27,"name":15,"description":38,"armGroupLabels":39,"otherNames":36},"Pregnant women in this arm will receive 6gms of IFA (Iron\u002FFolic Acid) in a ready to use sachet form which includes 2 nutrients.",[15],[41],{"name":42,"affiliation":5,"role":43},"Fyezah Jehan, MBBS; MSc","PRINCIPAL_INVESTIGATOR",[45,50],{"name":42,"role":46,"phone":47,"phoneExt":48,"email":49},"CONTACT","+9234930051","4793","fyezah.jehan@aku.edu",{"name":51,"role":46,"phone":47,"phoneExt":48,"email":52},"Zahra Hoodbhoy, PhD","zahra.hoodbhoy@aku.edu",[54],{"facility":55,"status":56,"city":57,"state":58,"zip":36,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Peri-Urban Slums of Karachi (Ali Akber Shah, Bhains Colony)","RECRUITING","Karachi","Sindh","Pakistan","PK",{"type":62,"coordinates":63},"Point",[64,65],67.0104,24.8608,{"lat":65,"lon":64},[68,72,74,77,78],{"name":69,"role":46,"phone":70,"phoneExt":48,"email":71},"Akber Madhwani","+92 21 111 911 911","akber.madhwani@aku.edu",{"name":73,"role":43,"phone":36,"phoneExt":36,"email":36},"Fyezah Jehan, MSc",{"name":75,"role":76,"phone":36,"phoneExt":36,"email":36},"Muhammad Imran Nisar, PhD","SUB_INVESTIGATOR",{"name":51,"role":76,"phone":36,"phoneExt":36,"email":36},{"name":79,"role":76,"phone":36,"phoneExt":36,"email":36},"Muhammad Farrukh Qazi, MSc",{"type":81,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[83],{"name":84,"class":6},"Vital Pakistan Trust","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":98,"type":99},3000,"ESTIMATED","INTERVENTIONAL",[102],"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.",[105,106,107,108,109,110],"Newborn Health","Multiple Micronutrient Deficiencies During Pregnancy","Nutrition During Pregnancy","Adaptive Trial","Postnatal Growth","Neurodevelopment Outcome",[112,113,114,115],"Antenatal Phase","Postnatal Phase","Micro Nutrient Supplementation","Infant Growth","2025-10-01",{"date":118,"type":119},"2025-10-07","ACTUAL",{"date":121,"type":119},"2025-07-08",{"date":123,"type":99},"2027-12-31",{"name":5,"class":6},1]