PACTR202307876581314
Not yet recruiting
Phase 4
Postpartum IV Iron to Treat Iron Deficiency Anemia Post Delivery (PRIORITY TRIAL). A Randomized Controlled Trial Of The Global Network For Women's and Children's Health Research Version 0.7 December 14, 2021
ational Institute of Child Health and Development0 sites600 target enrollmentJuly 6, 2023
ConditionsHaematological Disorders
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Haematological Disorders
- Sponsor
- ational Institute of Child Health and Development
- Enrollment
- 600
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
- •Women with known hemoglobinopathy (sickle cell disease or thalassemia)
- •Presence of severe allergic conditions such as severe asthma or known drug allergies
Outcomes
Primary Outcomes
Not specified
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