Maternal Anemia, Maternal Nutrition, Micronutrient Deficiency, Pregnancy Outcomes
Conditions
Keywords
Multiple Micronutrient Supplementation, MMS, Iron Folic Acid, IFA, Pregnancy, Maternal Anemia, Maternal Hemoglobin, Maternal Nutrition
Brief summary
This study aims to compare the effectiveness of Multiple Micronutrient Supplementation (MMS), Iron-Folic Acid (IFA) supplementation, and combined MMS+IFA supplementation among pregnant women. Maternal anemia and micronutrient deficiencies are common during pregnancy and can adversely affect both maternal and neonatal health outcomes. A total of 402 pregnant women with gestational age of 20 weeks or less will be randomly assigned to receive MMS, IFA, or combined MMS+IFA supplementation. Participants will be followed throughout pregnancy until delivery. Maternal hemoglobin levels, maternal compliance with supplementation, and neonatal outcomes including birth weight, preterm birth, APGAR scores, and congenital anomalies will be assessed. The findings of this study will provide evidence to guide antenatal nutrition policies and practices in Pakistan.
Detailed description
Maternal micronutrient deficiencies remain a major public health concern in low- and middle-income countries, including Pakistan. Iron deficiency anemia, along with deficiencies of folate, vitamin D, vitamin B12, zinc, iodine, and other micronutrients, contributes substantially to adverse maternal and neonatal outcomes. Although routine Iron-Folic Acid (IFA) supplementation is recommended during pregnancy, it may not adequately address the broader spectrum of micronutrient deficiencies commonly observed among pregnant women. Multiple Micronutrient Supplementation (MMS) has emerged as a comprehensive alternative that includes iron, folic acid, and additional essential vitamins and minerals required during pregnancy. Evidence from randomized controlled trials and systematic reviews suggests that MMS may improve selected neonatal outcomes; however, evidence regarding maternal hemoglobin improvement and compliance remains inconsistent across settings. Furthermore, limited data are available from Pakistan comparing MMS, IFA, and combined MMS+IFA supplementation. This study is a three-arm, parallel-group, open-label randomized controlled trial conducted at the antenatal clinics of the Sindh Institute of Child Health and Neonatology (SICHN) in Karachi and Jamshoro, Pakistan. A total of 402 eligible pregnant women with gestational age ≤20 weeks and baseline hemoglobin ≥10 g/dL will be enrolled and randomized in a 1:1:1 ratio to receive either MMS, IFA, or combined MMS+IFA supplementation. Maternal hemoglobin concentration will be measured at baseline, 28 weeks gestation, and 36-37 weeks gestation or delivery. Maternal compliance will be assessed using pill counts and self-reported supplement intake. Neonatal outcomes including birth weight, low birth weight, preterm birth, APGAR scores, and congenital anomalies will be evaluated at delivery. The study aims to compare the effectiveness of MMS, IFA, and MMS+IFA supplementation on maternal hemoglobin levels, neonatal outcomes, and maternal compliance. Findings from this study will contribute to strengthening evidence-based antenatal nutrition policies and maternal health programs in Pakistan.
Interventions
DIETARY_SUPPLEMENTMultiple Micronutrient Supplementation (MMS)
WHO-standard multiple micronutrient supplement containing iron, folic acid, zinc, iodine, vitamins A, D, C, and B-complex vitamins administered daily during pregnancy
DIETARY_SUPPLEMENTIron-Folic Acid (IFA)
Iron 60 mg and folic acid 400 µg administered daily during pregnancy.
Sponsors
Sindh Institute of Child Health and Neonatology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Participants will be randomized in a 1:1:1 ratio to one of three parallel study arms: Multiple Micronutrient Supplementation (MMS), Iron-Folic Acid supplementation (IFA), or combined MMS+IFA supplementation. Participants will remain in their assigned intervention group throughout the study period until delivery.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women aged 18 years or older * Gestational age ≤20 weeks at enrollment * Singleton pregnancy * Hemoglobin concentration ≥10 g/dL at baseline * Willing and able to provide informed consent * Willing to comply with study procedures and follow-up visits
Exclusion criteria
* Severe anemia requiring injectable treatment (hemoglobin \<7 g/dL) * Pre-existing diabetes mellitus * Pre-existing hypertension * Renal disease * Current therapeutic iron or micronutrient supplementation beyond routine antenatal supplementation * Known fetal congenital anomalies * Any medical condition that, in the opinion of the investigator, would interfere with study participation or outcome assessment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Hemoglobin Concentration | Baseline, 28 weeks gestation, and 36-37 weeks gestation or at delivery | Maternal hemoglobin concentration measured using complete blood count (CBC) and compared between study groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Birth Weight | At birth | Neonatal birth weight measured in grams within one hour of birth. |
Contacts
CONTACTSher Wali Khan, MS
PRINCIPAL_INVESTIGATORRozina Feroz Ali, MBBS, MSC
Sindh Institute of Child Health and Neonatology
Outcome results
None listed