Pregnancy Related
Conditions
Keywords
Pregnancy, Multiple Micronutrient Supplementation, Iron, Anemia, Tanzania
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.
Interventions
DIETARY_SUPPLEMENTMultiple Micronutrient Supplements with 30 mg of elemental iron
MMS with 30 mg iron is the active comparator group. The standard UNIMMAP MMS formulation includes 30 mg of iron which will be taken orally once daily from the time of randomization until delivery.
DIETARY_SUPPLEMENTMultiple Micronutrient Supplements with 45 mg of elemental iron
MMS with 45 mg iron is an intervention group. MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily from the time of randomization until delivery.
DIETARY_SUPPLEMENTMultiple Micronutrient Supplements with 60 mg of elemental iron
MMS with 60 mg iron is an intervention group. MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily from the time of randomization until delivery.
Sponsors
George Washington University
Ifakara Health Institute
Harvard School of Public Health (HSPH)
Muhimbili University of Health and Allied Sciences
Africa Academy for Public Health
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The trial is quadruple blind with all trial participants, outcome assessors (research staff and care providers), investigators, and trials statistician and data analysts being unable to determine the allocated trial arm for any trial participant or identify trial participants who are on the same trial regimen.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Maternal hemoglobin concentration | 3rd trimester (weeks 28-42 of pregnancy) | 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 | 3rd trimester (weeks 28-42 of pregnancy) | 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 | 3rd trimester (weeks 28-42 of pregnancy) | 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 |
Countries
Tanzania
Contacts
CONTACTEmily R Smith, ScD, MPH
CONTACTChristopher R Sudfeld, ScD, ScM
PRINCIPAL_INVESTIGATORBlair Wylie, MD, MPH
Columbia University
PRINCIPAL_INVESTIGATORHonorati Masanja, PhD
Ifakara Health Institute
PRINCIPAL_INVESTIGATORAlfa Muhihi, MD, MPH
Africa Academy for Public Health
PRINCIPAL_INVESTIGATORAndrea Pembe, MD, MMed, PhD, FCOG
Muhimbili University of Health and Allied Sciences
PRINCIPAL_INVESTIGATOREmily R Smith, ScD, MPH
The Goerge Washington University
PRINCIPAL_INVESTIGATORChristopher R Sudfeld, ScD, ScM
Harvard University
Outcome results
None listed