Understanding hydroxyurea effects during pregnancy and breastfeeding in women with sickle cell disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to document and analyze the effects of hydroxyurea exposure on women with sickle cell disease (SCD) and their infants during pregnancy and lactation. It will involve chart reviews and surveys to gather data on medical records of pregnant women with SCD who have been exposed to hydroxyurea, including those who experienced miscarriages or stillbirths. The study seeks to clarify the potential risks and outcomes associated with hydroxyurea use in this population, addressing a critical gap in existing knowledge regarding maternal and infant health. By examining both hydroxyurea-exposed and non-exposed pregnancies, the study aims to provide insights into the safety and implications of this treatment during critical periods.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Principal investigator: Russell Ware, MD — Children's Hospital Medical Center, Cincinnati
• Study coordinator: Teresa Latham
• Email: Teresa.Latham@cchmc.org
• Phone: 513-803-7922

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.