Hydroxyurea Exposure Limiting Pregnancy and Follow-Up Lactation
Recruiting · NCT04093986 · Observational (researchers observe without assigning treatment) · Lead sponsor: Children's Hospital Medical Center, Cincinnati
View the official record on ClinicalTrials.gov →Interventions studied
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What this trial is about
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.
Who can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
1 location listed across 1 US state.
- Cincinnati Children's Hospital Medical Center - Cincinnati, Ohio, United States