Status:
RECRUITING
Hydroxyurea Exposure Limiting Pregnancy and Follow-Up Lactation
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
University of Connecticut
University of Colorado, Denver
Conditions:
Sickle Cell Disease
Sickle Cell Anemia
Eligibility:
All Genders
Brief Summary
The purpose of this research study is to document and understand the effects of hydroxyurea exposure for women with SCD and their babies, during both gestation and lactation.
Detailed Description
Hydroxyurea (hydroxycarbamide) is the primary disease-modifying therapy for individuals with sickle cell disease (SCD) and is both US FDA- and EMA-approved for SCD treatment. Decades of research have ...
Eligibility Criteria
Inclusion
- Medical records or data available from previous clinical care prior to June 20, 2019 of pregnant females with SCD, including women who miscarried, had a still birth, or completed labor at any gestational stage, with any hydroxyurea exposure during either pregnancy and/or while breastfeeding.
- Medical records or data available from previous clinical care prior to June 20, 2019 about pregnancy and breastfeeding outcomes, both for babies with hydroxyurea exposure and other babies by these same women.
Exclusion
- Unavailable medical records or lack of information about hydroxyurea exposure.
Key Trial Info
Start Date :
December 22 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04093986
Start Date
December 22 2019
End Date
December 1 2026
Last Update
July 17 2025
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229