RecruitingNCT04093986

Hydroxyurea Exposure Limiting Pregnancy and Follow-Up Lactation

Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

200 participants

Start Date

Dec 22, 2019

Study Type

OBSERVATIONAL

Conditions

Sickle Cell Disease Sickle Cell Anemia

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

Plain Language Summary

Simplified for easier understanding

This is a records-based study looking back at the health outcomes of pregnant women with sickle cell disease (SCD) who were exposed to hydroxyurea — a medication used to treat SCD — during pregnancy or while breastfeeding. Researchers want to understand how this exposure affects mothers and their babies. You may be eligible if: - Your medical records document a pregnancy while you had SCD (including miscarriage, stillbirth, or live delivery) - You had any exposure to hydroxyurea during pregnancy or while breastfeeding before June 20, 2019 You may NOT be eligible if: - Your medical records are unavailable or do not contain information about hydroxyurea exposure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERChart Review

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.

OTHERSurvey

Women who choose to participate directly and provide information in survey format will receive a brief survey and the option to upload their medical records (if available) into Cincinnati Children's maintained REDCap database.