Understanding hydroxyurea effects during pregnancy and breastfeeding in women with sickle cell disease
Hydroxyurea Exposure Limiting Pregnancy and Follow-Up Lactation
Children's Hospital Medical Center, Cincinnati · NCT04093986
This study looks at how taking hydroxyurea during pregnancy and breastfeeding affects women with sickle cell disease and their babies to better understand the risks and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati (other) |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT04093986 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women with sickle cell disease who have been exposed to hydroxyurea during pregnancy or breastfeeding.
Not a fit: Patients who do not have access to medical records or lack information about hydroxyurea exposure will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide essential information to improve the management of pregnant women with sickle cell disease and enhance outcomes for both mothers and their babies.
How similar studies have performed: While there is limited data on hydroxyurea exposure during pregnancy, previous studies have documented its benefits in treating sickle cell disease, making this investigation both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cincinnati, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sickle Cell Disease, Sickle Cell Anemia, Hydroxyurea