Scanning of brain of babies of IV Iron Trial
- Conditions
- Health Condition 1: O990- Anemia complicating pregnancy, childbirth and the puerperium
- Registration Number
- CTRI/2022/11/047102
- Lead Sponsor
- Bill and Melinda Gates Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
a. For the maternal participant in the RAPIDIRON Trial â?? a pregnancy that has not gone beyond the period for obtaining a fetal MRI (by scanning the mother at 32-35 weeks fetal gestational age);
b. An indication of the pregnant womanâ??s intent to deliver in the study area and to reside there so as to be available not only to complete RAPIDIRON participation but also to allow her and her offspring to participate in ancillary study visits;
c. Informed consent of the pregnant RAPIDIRON participant for her participation and that of her offspring in the ancillary trial;
d. Concurrent participation in the RAPIDIRON-KIDS follow-up study.
a. If a fetal brain anomaly is found when the maternal participant undergoes an MRI at 32-35 weeks fetal gestational age, the dyad would be excluded from the ancillary study;
b. If any of the following occur, this would result in dyad ineligibility for participation or continued participation in this ancillary study: maternal blood transfusion after enrollment, a pregnancy ending in stillbirth, neonatal death, diagnosis in the offspring of moderate to severe hypoxic-ischemic encephalopathy (or HIE), and/or blood transfusion to the offspring.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Imaging Endpoints for this study on Fetal MRI are: <br/ ><br>1. Hippocampus volumes <br/ ><br>2. White matter microstructure (FA and MD) at the posterior limb of internal capsuleTimepoint: At 32-35 weeks fetal gestational age
- Secondary Outcome Measures
Name Time Method