Postpartum IV Iron to Treat Iron Deficiency Anemia Post Delivery Trial
- Conditions
- Haematological Disorders
- Registration Number
- PACTR202307876581314
- Lead Sponsor
- ational Institute of Child Health and Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 600
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maternal non-anemic state (Hb >11 g/dL) at 6 weeks post-delivery
- Secondary Outcome Measures
Name Time Method