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

NCT07029282 | Recruiting Phase 3 DMC

• 1 other identifier: 2024-10733-31927
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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?
3. 3.MMS Plus versus standard MMS during pregnancy (antenatal phase)
4. 4.MMS Plus versus standard MMS versus IFA after birth (postnatal phase)
5. 5.Be randomly assigned to receive either MMS Plus or standard MMS during pregnancy
6. 6.Be re-randomized after delivery to receive either MMS Plus, standard MMS, or IFA supplements during the postnatal period
7. 7.Receive supplements under double-blind conditions
8. 8.Be followed through childbirth and until the infant is 6 months of age
9. 9.Attend regular clinic visits for health monitoring, infant assessments, and data collection.

Conditions

Newborn Health; Multiple Micronutrient Deficiencies During Pregnancy; Nutrition During Pregnancy; Adaptive Trial; Postnatal Growth; Neurodevelopment Outcome

Keywords

Antenatal Phase; Postnatal Phase; Micro Nutrient Supplementation; Infant Growth

Outcome Measures

Primary Outcomes (2)

• 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)

  28 days after birth

• 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

  Birth to 6 months

Secondary Outcomes (14)

• Gestational Weight Gain (GWG)

  At birth

• Intrauterine Growth Restriction (IUGR)

  GA 20 and 32 weeks

• Gestational age at birth

  Within 72 hours of birth

• Birth Weight (gm)

  Within 72 hours of birth

• Birth length (cm)

  within 72 hours of birth

Other Outcomes (3)

• Maternal weight

  1, 2, 4, 6, 12, 24 months of life

• Maternal MUAC (cm)

  1, 2, 4, 6, 12, 24 months of life

• Maternal morbidity

  Every ANC visit and within 72 hours of birth

Study Arms (3)

MMS

ACTIVE COMPARATOR

Once daily dose of MMS sachet + Standard ANC and nutrition counseling

Dietary Supplement: MMS

IFA

ACTIVE COMPARATOR

Once daily dose of IFA sachet + Standard postnatal care (PNC) and nutrition counseling

Dietary Supplement: IFA

MMS Plus

EXPERIMENTAL

One daily sachet of MMS PLUS + Standard ANC and nutrition counseling

Drug: MMS Plus

Interventions

MMS 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.

Also known as: UNIMAPP MMS

MMS

MMS Plus DRUG

Pregnant women in this arm will receive 6gms of MMS Plus in a ready to use sachet form which includes 18 nutrients.

MMS Plus

IFA DIETARY_SUPPLEMENT

Pregnant women in this arm will receive 6gms of IFA (Iron/Folic Acid) in a ready to use sachet form which includes 2 nutrients.

IFA

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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::
• 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
• 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

Sponsors & Collaborators

• Aga Khan University: lead
• Vital Pakistan Trust: collaborator

Study Sites (1)

Peri-Urban Slums of Karachi (Ali Akber Shah, Bhains Colony)

Karachi, Sindh, Pakistan

RECRUITING

Related Publications (6)

• Amoroso L. Post-2015 Agenda and Sustainable Development Goals: Where Are We Now? Global Opportunities to Address Malnutrition in all Its Forms, Including Hidden Hunger. World Rev Nutr Diet. 2017;118:45-56. doi: 10.1159/000484334. Epub 2018 Apr 13.

  PMID: 33503779 BACKGROUND

• GNR. The state of global nutrition. Development Initiatives Bristol (UK); 2021

  BACKGROUND

• UNICEF. National Nutrition Survey 2018. Key Findings Report Ministry of Health Services, Nutrition Wing, Regulation and Coordination, Government of Pakistan, Pakistan. 2019

  BACKGROUND

• WHO Recommendations on Antenatal Care for a Positive Pregnancy Experience. Geneva: World Health Organization; 2016. Available from http://www.ncbi.nlm.nih.gov/books/NBK409108/

  PMID: 28079998 BACKGROUND

• Bourassa MW, Osendarp SJM, Adu-Afarwuah S, Ahmed S, Ajello C, Bergeron G, Black R, Christian P, Cousens S, de Pee S, Dewey KG, Arifeen SE, Engle-Stone R, Fleet A, Gernand AD, Hoddinott J, Klemm R, Kraemer K, Kupka R, McLean E, Moore SE, Neufeld LM, Persson LA, Rasmussen KM, Shankar AH, Smith E, Sudfeld CR, Udomkesmalee E, Vosti SA. Review of the evidence regarding the use of antenatal multiple micronutrient supplementation in low- and middle-income countries. Ann N Y Acad Sci. 2019 May;1444(1):6-21. doi: 10.1111/nyas.14121. Epub 2019 May 27.

  PMID: 31134643 BACKGROUND

• Keats EC, Haider BA, Tam E, Bhutta ZA. Multiple-micronutrient supplementation for women during pregnancy. Cochrane Database Syst Rev. 2019 Mar 14;3(3):CD004905. doi: 10.1002/14651858.CD004905.pub6.

  PMID: 30873598 BACKGROUND

Related Links

• WHO, Malnutrition, 2021

Study Officials

• Fyezah Jehan, MBBS; MSc

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fyezah Jehan, MBBS; MSc

CONTACT

+9234930051; fyezah.jehan@aku.edu

Zahra Hoodbhoy, PhD

CONTACT

+9234930051; zahra.hoodbhoy@aku.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: During the antenatal phase, participants will be randomized into one of two arms (MMS vs MMS Plus). However during the postnatal phase, those same participants will be re-randomized into three arms (MMS vs MMS Plus vs IFA).

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 19, 2025
• Study Start: July 8, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 7, 2025

Record last verified: 2025-10

Locations

PA (1)