Status:
COMPLETED
Reducing Anemia in Pregnancy in India: the RAPIDIRON Trial
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
Children's Investment Fund Foundation
Jawaharlal Nehru Medical College
Conditions:
Iron Deficiency Anemia
Infant, Low Birth Weight
Eligibility:
FEMALE
18-40 years
Phase:
PHASE4
Brief Summary
Anemia is a worldwide problem with iron deficiency being the most common cause. When anemia occurs in pregnancy, it increases the risk of adverse maternal, fetal, and postnatal outcomes. Anemia rates ...
Detailed Description
Anemia is a worldwide problem with iron deficiency being the most common cause. When occurring in pregnancy, anemia increases the risk of adverse maternal, fetal and neonatal outcomes, including mater...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Study Consent for Initial Participation:
- Pregnant women between 18-40 years of age at time of consent that received education about the study and were capable of giving informed consent;
- Hemoglobin concentration of 7 - 10.4 g/dL;
- Expressed intent and expectation of remaining in the designated research area during pregnancy and delivering in a facility in or near the research area and remaining in the area to enable study participant and data collection consistent with the research protocol;
- Expressed willingness that specifically includes agreement to randomization to the standard care study arm (of oral iron) or to one of the two arms involving treatment with single-dose IV iron.
- Additional Inclusion Criteria for Randomization and Continued Study Participation:
- Iron deficiency anemia, defined for this study as moderate anemia with hemoglobin concentration level between 7 - 9.9 g/dL, serum transferrin saturation (TSAT) \<20%, and/or ferritin \<30 ng/mL;
- Presence of a live, singleton, intrauterine fetus and dating ultrasound (at visit #2) that indicates a pregnancy that, at randomization, would be between the beginning of week 14 and prior to 17 weeks 0 days.
- Exclusion Criteria:
- Fetal anomaly, if detectable when an initial ultrasound is done to date the pregnancy (subsequent discovery of a fetal anomaly is not viewed as an exclusion criterion);
- History of cardiovascular disease, hemoglobinopathy, or other disease or condition considered a contraindication for treatment, including conditions recommended for exclusion by the manufacturers of oral or IV iron to be used in this study;
- Any condition that, in the opinion of the consenting physician, warrants study exclusion.
Exclusion
Key Trial Info
Start Date :
March 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2024
Estimated Enrollment :
4368 Patients enrolled
Trial Details
Trial ID
NCT05358509
Start Date
March 15 2021
End Date
January 21 2024
Last Update
May 24 2024
Active Locations (4)
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1
S. Nijalingappa Medical College
Bagalkot, Karnataka, India
2
Jawaharlal Nehru Medical College
Belagavi, Karnataka, India
3
Raichur Institute of Medical Sciences
Rāichūr, Karnataka, India
4
Sawai Man Singh Medical College
Jaipur, Rajasthan, India