Health Condition 1: O990- Anemia complicating pregnancy, childbirth and the puerperium
Conditions
Interventions
Intervention1: IV Iron Arm (Iron Isomaltoside): Dose-up to 1 g
Frequency-Single dose
Route of administration-Intravenous
Duration of therapy-A single dose administered between 6 and 48 hours post-d
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development
Eligibility
Inclusion criteria
Inclusion criteria: 1. Established pregnancy >20 wk gestation by LMP and/or clinical assessment 2. Confirmed moderate anemia (Hb 7.0 to 9.9 g/dL, 6-48 hr after delivery based on a venous blood sample) 3. Deliver in participating study hospital or health facility 4. Able to provide informed consent 5. Plans to remain in study area for duration of the study
Exclusion criteria
Exclusion criteria: 1. Contraindication to iron supplementation 2. Blood transfusion already received or scheduled 3. Known diagnosis of pre-existing depression or other psychiatric illness 4. Stillbirth, major congenital anomaly, or neonatal loss prior to facility discharge 5. Women testing positive and previously untreated for malaria 6. Presenting with symptomatic anemia with dyspnea or fatigue and need for immediate correction 7. Women with known hemoglobinopathy (sickle cell disease or thalassemia) 8. Presence of severe allergic conditions such as severe asthma or known drug allergies 9. Women presenting with any illness/condition requiring immediate medical care per physicianâ??s assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maternal non-anemic stateTimepoint: At 6 weeks post-delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Change resulting in severe/moderate/mild anemia by treatment armTimepoint: At 6 months;Differences in ferritin and inflammatory markers on all randomized patientsTimepoint: At delivery, 6 weeks and 6 months;Documentation of major antenatal or intrapartum complications (diabetes, preeclampsia, fetal demise)Timepoint: From delivery to 6 months post-delivery;Exclusive breastfeeding rateTimepoint: At 6 weeks and 6 months;Hb concentration and ferritinTimepoint: During first trimester of an intercurrent pregnancy;Hemoglobin concentration by mode of deliveryTimepoint: At 6 months;HospitalizationTimepoint: From delivery to 6 months post-delivery;Infant hospitalizationTimepoint: Birth to 6 months;Infant-mother bonding scale scoresTimepoint: 6 weeks;Intent to continue breastfeeding through 12 months post-deliveryTimepoint: At 6 months;Maternal fatigue severity scoresTimepoint: At 6 weeks and 6 months;Maternal mortalityTimepoint: From delivery to 6 months post-delivery;Neonatal/infant mortalityTimepoint: Birth to 6 months;Post-discharge blood transfusionTimepoint: From delivery to 6 months post-delivery;Postpartum hemorrhage requiring transfusion or major surgeryTimepoint: From intervention through 6 weeks post-delivery;Prevalence of severe/moderate/mild anemiaTimepoint: At time of recruitment and at 6 months;Quality of life assessment scoresTimepoint: At 6 weeks and 6 months;Rate of screening for postpartum depressionTimepoint: At 6 weeks and 6 months | — |
Countries
Bangladesh, Democratic Republic of the Congo, Guatemala, India, Kenya, Pakistan, Zambia
Contacts
Public ContactDr Shivaprasad S Goudar
J N Medical College, KLE Academy of Higher Education and Research
Outcome results
None listed