Health Condition 1: O990- Anemia complicating pregnancy, childbirth and the puerperium
Conditions
Interventions
None listed
Sponsors
Bill and Melinda Gates Foundation
Thomas Jefferson University
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Imaging Endpoints for this study on Fetal MRI are: 1. Hippocampus volumes 2. White matter microstructure (FA and MD) at the posterior limb of internal capsuleTimepoint: At 32-35 weeks fetal gestational age | — |
Secondary
| Measure | Time frame |
|---|---|
| Cerebral metabolism (perfusion and spectroscopy) on Child 3T MRITimepoint: Infant/young child (at 4, 12, and 24 months of age);Child Auditory brainstem evoked response (ABR)Timepoint: At birth and 4 months of age;Child hair cortisol levels to assess general chronic stressTimepoint: At birth;For breastfeeding mothers, breastmilk sample analysis for general lipid, protein, carbohydrate, and energy content, as well as more fine-grained measures of individual micronutrients, as well as cholesterol.Timepoint: At the 4-month visit;Functional connectivity on Child 3T MRITimepoint: Infant/young child (at 4, 12, and 24 months of age);Hippocampus volumes (and other sub-cortical gray matter structures) on Child 3T MRITimepoint: Infant/young child (at 4, 12, and 24 months of age);Maternal anxiety assessed using the State-Trait Anxiety InventoryTimepoint: At the prenatal (32-35 weeks gestational age), 4, 12, and 24 month visits;Maternal depression assessed using the Edinburgh Post-Natal Depression scaleTimepoint: At the prenatal (32-35 weeks gestational age), 4, 12, and 24 month visits;Maternal hair cortisol levels to assess general chronic stressTimepoint: At the prenatal (32-35 weeks gestational age) visits;Maternal perceived stress assessed using the Perceived Stress Scale (PSS-10)Timepoint: At the prenatal (32-35 weeks gestational age), 4, 12, and 24 month visits;Maternal SWPER Global Survey to assess level of empowermentTimepoint: At the prenatal (32-35 weeks gestational age), 4, 12, and 24 month visits;Other sub-cortical gray matter structures on Fetal MRITimepoint: At 32-35 weeks fetal gestational age;Other white matter microstructure measures (e.g. qT2, MTR, NODDI metrics) on Fetal MRITimepoint: At 32-35 weeks fetal gestational age;White matter connectivity on Child 3T MRITimepoint: Infant/young child (at 4, 12, and 24 months of age);White matter microstructure, including myelination, fiber coherence and architecture on Child 3T MRITimepoint: Infant/young child (at 4, 12 | — |
Countries
India
Contacts
Public ContactDr Shivaprasad S Goudar
KLE Academy of Higher Education and Researchs J N Medical College
Outcome results
None listed