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.
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.
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.
Birth weight available within 72 hours
Factorial
MMS
Dietary supplementPregnant women in this arm will receive 6gms of MMS (UNIMAPP MMS) in a ready to use sachet form which includes 15 nutrients.
MMS Plus
DrugPregnant women in this arm will receive 6gms of MMS Plus in a ready to use sachet form which includes 18 nutrients.
IFA
Dietary supplementPregnant women in this arm will receive 6gms of IFA (Iron/Folic Acid) in a ready to use sachet form which includes 2 nutrients.
Antenatal Phase: Composite Infant Health Score at 28 Days Post-Birth
Infant health will be assessed using a 5-point ordinal categorical scale, defined as follows: Stillbirth, miscarriage, or early neonatal death (0-6 days); Preterm birth with Small for Gestational Age (SGA) infant; Preterm birth with Appropriate or Large for Gestational Age (AGA or LGA) infant; Term birth with SGA infant; Term birth with AGA or LGA infant Method of Aggregation: Proportion of participants in each outcome category Analysis Metric: Ordinal regression (e.g., Bayesian cumulative logistic regression)
Postnatal Phase: Infant linear growth velocity at 6 months
Infant linear growth velocity, calculated as: Length Velocity (cm/month) = Length at 6 months - Length at birth / Age in days / 30.4 Only infants exclusively/predominantly breastfed through 6 months will be included in this analysis. Method of Aggregation: Mean length velocity per intervention group Analysis Metric: Continuous variable; analysed using ANOVA or regression models with pairwise comparisons
Gestational Weight Gain (GWG)
Change in maternal weight during pregnancy, measured in kilograms (kg) from baseline (enrollment) to the time of delivery. Gestational weight gain will be reported both as: Absolute weight gain (kg) Z-scores and percentiles, adjusted for gestational age, based on WHO or INTERGROWTH standards Greater weight gain within recommended ranges is considered indicative of improved maternal nutritional status and better fetal outcomes.
Intrauterine Growth Restriction (IUGR)
Episodes of IUGR measured at two timepoints during antenatal phase measured through ultrasound to assess growth of fetus in relation to weight and size
Gestational age at birth
Gestational age at birth, measured in completed weeks, will be assessed using first-trimester ultrasound dating (8-14 weeks gestation). Higher gestational age indicates a better outcome in terms of fetal maturity and reduced risk of neonatal complications. Method of aggregation: Mean gestational age (weeks); proportion of births in each gestational age category (preterm, term, post-term)
Birth Weight (gm)
Weight of the newborn assess in gram to assess the difference between the arms
Maternal weight
Maternal body weight, measured in kilograms (kg), will be assessed after delivery to evaluate maternal nutritional status following supplementation during the postnatal phase. Weight will be measured using calibrated digital scales under standardized conditions. Higher weight (within normal postpartum range) indicates better nutritional recovery and health status.
Maternal MUAC (cm)
Mean difference of MUAC in cm to look at comparison between multiple arms
Maternal morbidity
Episodes of maternal morbidities such as preeclampsia, gestational diabetes mellitus, hypertensive disorders in between the arms
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Aga Khan University
Lead sponsor
Vital Pakistan Trust
Collaborator
