Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania
- Conditions
- Pregnancy Related
- Interventions
- Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental ironDietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental ironDietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron
- Registration Number
- NCT06079918
- Lead Sponsor
- George Washington University
- Brief Summary
This is an individually randomized controlled trial to assess the effect of multiple micronutrient supplements (MMS) containing 60 and 45 mg iron as compared to MMS containing 30 mg of iron (standard UNIMMAP formulation) on maternal moderate or severe anemia. This study will help inform countries like Tanzania that currently use IFA containing 60 mg of iron regarding the dose of iron to use in MMS.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 6381
- Attending first ANC visit at study clinics
- Pregnant women < 20 weeks gestation by last menstrual period (LMP)
- Aged ≥ 18 years old
- Intending to stay in Dar es Salaam until 6 weeks post delivery
- Provides informed consent
- Severe anemia (defined as hemoglobin < 8.5 g/dL per Tanzania standard of care)
- Sickle cell disease (SS and SC) and hemoglobin C disease (CC) as tested by HemoTypeSC
- Concurrently enrolled in another nutritional clinical trial
- Pregnant women with disability or condition which would impair their ability to provide informed consent and complete study procedures.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MMS with 30 mg iron Multiple Micronutrient Supplements with 30 mg of elemental iron MMS with standard UNIMMAP formulation of 15 micronutrients, including 30 mg of iron MMS with 45 mg iron Multiple Micronutrient Supplements with 45 mg of elemental iron MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients MMS with 60 mg iron Multiple Micronutrient Supplements with 60 mg of elemental iron MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients
- Primary Outcome Measures
Name Time Method Proportion of pregnant women with third-trimester moderate or severe anemia 3rd trimester (weeks 28-42 of pregnancy) Defined as a hemoglobin concentration \<10 g/dL.
- Secondary Outcome Measures
Name Time Method Maternal hemoglobin concentration 6 weeks postpartum Continuous hemoglobin concentration measured from venous blood by complete blood count
Proportion of pregnant women with anemia 3rd trimester (weeks 28-42 of pregnancy) Hb concentration \< 11 g/dL
Proportion of postpartum women with anemia 6 weeks postpartum Hb concentration \< 12 g/dL
Maternal serum ferritin 3rd trimester (weeks 28-42 of pregnancy) Inflammation-adjusted serum ferritin
Proportion of pregnant women with iron deficiency 3rd trimester (weeks 28-42 of pregnancy) Inflammation-adjusted serum ferritin \< 15 ug/L
Proportion of pregnant women with iron deficiency anemia 3rd trimester (weeks 28-42 of pregnancy) Anemia (Hb \< 11 g/dL) and iron deficiency (inflammation-adjusted serum ferritin \< 15 ug/L)
Proportion of women with preeclampsia From 20 weeks gestation through delivery Gestational hypertension and gestational proteinuria among participants without chronic hypertension or gestational proteinuria among participants with chronic hypertension (superimposed preeclampsia) or clinical diagnosis of preeclampsia by managing clinical team or development of severe features of preeclampsia even in the absence of proteinuria
Proportion of women with antepartum bleeding From 24 weeks gestation through delivery Self-reported or clinical diagnosis of bleeding from or into the genital tract
Proportion of women with postpartum hemorrhage From delivery through 42 days post delivery Clinical diagnosis of postpartum hemorrhage or use of critical interventions to treat postpartum hemorrhage
Proportion of women with infection-related severe maternal outcomes During pregnancy through 42 days postpartum Severe infection-related such as hospitalization for infection, women presenting with WHO near-miss criteria to define organ system dysfunction, invasive procedure to treat the source of infection (vacuum aspiration, dilatation and curettage, wound debridement, drainage, laparotomy and lavage, other surgery), or maternal death from infection.
Proportion of women with pregnancy-related death Pregnancy through 42 days of pregnancy termination Death of a woman while pregnant or within 42 days of termination of pregnancy, irrespective of the cause of death
Proportion of women with symptoms consistent with depression 6 weeks postpartum Patient Health Questionnaire-9 (PHQ-9) score ranging from 0 to 27, with higher scores consistent with depression and anxiety
Proportion of women with symptoms consistent with fatigue 6 weeks postpartum FACIT assessment score ranging from 0 to 52, with lower scores consistent with fatigue.
Proportion of women with malaria infection Pregnancy through 42 days postpartum Based on HRP2 biomarker or rapid-diagnostic tests (RDTs)
Proportion of fetal deaths At pregnancy termination (weeks 1-42 of pregnancy) A product of human conception, irrespective of the duration of the pregnancy, which, after expulsion or extraction, does not breath or show any other evidence of life such as beating of the heart, pulsation of the umbilical cord, or definite movement of voluntary muscles, whether or not the umbilical cord has been cut or the placenta is attached
Proportion of stillbirths At pregnancy termination (weeks 1-42 of pregnancy) Fetal death ≥ 28 weeks gestation
Birthweight At birth Continuous birthweight among live births
Proportion of live births with low birthweight At birth Live birth with birthweight \< 2500 g
Gestational age at birth At birth Duration of gestation in weeks as a continuous measure among live births based on best obstetric estimate among live births
Proportion of preterm live births At birth Live birth \<37 weeks gestation (based on best obstetric estimate)
Birthweight for gestational age At birth Continuous centile based on INTERGROWTH-21st standard birth centile among live births
Proportion of small-for-gestational age live births (<10th percentile) At birth Size-for-gestational age \<10th on the INTERGROWTH-21st standard among live births
Proportion of small-for-gestational age live births (<3rd percentile) At birth Size-for-gestational age \<3rd percentile on the INTERGROWTH-21st standard among live births
Infant hemoglobin concentration At 6 weeks of age Continuous Hb concentration measured from capillary blood by complete blood count
Infant serum ferritin At 6 weeks of age Continuous inflammation adjusted serum ferritin
Proportion of infants with iron deficiency At 6 weeks of age Inflammation-adjusted serum ferritin \< 20 ug/L
Proportion of neonatal deaths From birth to 28 days of age Death of liveborn infant during the first 28 completed days of life
Proportion of infant deaths < 42 days From birth to 42 days of age Death of a live born infant during the first 42 completed days of life
Trial Locations
- Locations (1)
Muhimbili University of Health and Allied Sciences
🇹🇿Dar es Salaam, Tanzania