Plain-English translation of NCT04093986 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our Sickle Cell Disease research guide →This study is gathering medical records from women with sickle cell disease who used hydroxyurea during pregnancy or while breastfeeding. Hydroxyurea is an important medication that helps many people with sickle cell disease feel better and live longer, but doctors currently warn against using it during pregnancy because of theoretical safety concerns that have never actually been seen in real patients. By collecting real-world experiences from women and their babies, this research aims to understand whether the medication is truly unsafe during pregnancy or whether it might actually be safe to continue.
Women with sickle cell disease often have serious health problems during pregnancy, and the medication is one of the most effective treatments available to protect their health. However, because of warnings on the medication label, many women are forced to stop taking it when they become pregnant—which can be harmful to their own health. This study exists to find out whether those warnings are based on real human evidence or whether continuing this treatment during pregnancy might actually be safe and beneficial.
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You can participate in two ways: either by allowing your healthcare provider to share your medical records from before June 2019, or by uploading your own deidentified medical records directly through an online form and answering a brief questionnaire about your pregnancy and breastfeeding experience. There are no clinic visits, no new treatments, and no blood tests—you are simply helping researchers review what already happened in your medical care to learn whether the medication was safe for you and your baby.
AI-generated summary from trial data · Jun 3, 2026 · Not medical advice
United States
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
University of Connecticut, University of Colorado, Denver
Enrollment target
~200 participants
Started
December 2019
Primary completion
December 2025
This trial's estimated completion date has passed — the record may not be fully up to date.
Last updated on clinicaltrials.gov in July 2025.
Reach out to the team running this trial. Response times vary — some teams are faster than others.
Central contact
Teresa Latham
Children's Hospital Medical Center, Cincinnati
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.