Haematological Disorders
Conditions
Interventions
Oral Iron and folate
Sponsors
National Institute of Child Health and Development
Bill and Melinda Gates Foundation
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Established pregnancy >20 wk gestation by LMP and/or clinical assessment and/ Or USG • Age: 15 years (or lower limit age eligible*) to 49 years • Confirmed moderate anemia (Hb 7.0 to 9.9 g/dL, 6-48 hr after delivery based on a venous blood sample on Hemocue®) • Deliver in participating study hospital or health facility • Able to provide informed consent • Plans to remain in study area for duration of the study
Exclusion criteria
Exclusion criteria: IV Iron infusion already received in past 3 weeks • Contraindication to iron supplementation (some examples may include hemolytic anemia, allergy, severe infection) • Blood transfusion already received or scheduled in the current hospital admission • Known diagnosis of pre-existing depression or other psychiatric illness • Stillbirth, major congenital anomaly, or neonatal loss prior to randomization • Women testing positive and previously untreated for malaria • Presenting with symptomatic anemia with dyspnea or fatigue and need for immediate correction • Women with known hemoglobinopathy (sickle cell disease or thalassemia) • Presence of severe allergic conditions such as severe asthma or known drug allergies • Women presenting with any illness/condition requiring immediate medical care per physician’s assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maternal non-anemic state (Hb >11 g/dL) at 6 weeks post-delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Maternal mortality (from delivery to 6 mo post-delivery) • Post-discharge blood transfusion through 6 mo post-delivery • Postpartum hemorrhage (from intervention through 6 wk post-delivery) requiring transfusion or major surgery • Hospitalization (as an indicator to capture infection through 6 mo post-delivery) • Documentation of intrapartum complications (diabetes, preeclampsia, fetal demise) • Rate of screening for postpartum depression (6 wk, 6 mo) • Maternal fatigue severity scores (6 wk, 6 mo) • Infant-mother bonding scale scores (6 wk • Quality of life assessment scores (6 wk, 6 mo) • Prevalence of severe/moderate/mild anemia (also at time of recruitment and at 6 mo) 5 • Change resulting in severe/moderate/mild anemia by treatment arm (6 mo) • Hemoglobin concentration by mode of delivery (6 mo) • Differences in ferritin and inflammatory markers on all randomized patients (delivery, 6 wk, 6 mo) • Hb concentration and ferritin measured in first trimester of an intercurrent pregnancy Infant • Neonatal/infant mortality (birth to 6 mo) • Infant hospitalization (birth to 6 mo) • Exclusive breastfeeding rate (6 wk, 6 mo) and intent to continue breastfeeding through 12 mo post-delivery (6 mo) | — |
Countries
Kenya
Contacts
Public ContactElizabeth Mc lure
Data Coordinating Center
Outcome results
None listed