NCT04093986 Hydroxyurea Exposure Limiting Pregnancy and Follow-Up Lactation
| NCT ID | NCT04093986 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Sickle Cell Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2019-12-22 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2019-12-22 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * Unavailable medical records or lack of information about hydroxyurea exposure.
Contact & Investigator
Russell Ware, MD
PRINCIPAL INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Frequently Asked Questions
Who can join the NCT04093986 clinical trial?
This trial is open to participants of all sexes, studying Sickle Cell Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04093986 currently recruiting?
Yes, NCT04093986 is actively recruiting participants. Contact the research team at Teresa.Latham@cchmc.org for enrollment information.
Where is the NCT04093986 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT04093986 clinical trial?
NCT04093986 is sponsored by Children's Hospital Medical Center, Cincinnati. The principal investigator is Russell Ware, MD at Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 200 participants.
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