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Search / Trial NCT04093986

Hydroxyurea Exposure Limiting Pregnancy and Follow-Up Lactation

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Sep 16, 2019

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Hydroxyurea

ClinConnect Summary

This clinical trial is exploring how exposure to a medication called hydroxyurea affects women with sickle cell disease (SCD) during pregnancy and breastfeeding, as well as how it impacts their babies. Hydroxyurea is often used to help manage SCD, but researchers want to gather more information about its safety and effects when taken by pregnant women or those who are nursing.

To participate in this study, women must have medical records showing their pregnancies and any hydroxyurea use before June 20, 2019. This includes women who have experienced miscarriages, stillbirths, or who have given birth at any stage of pregnancy, and it also includes their breastfeeding experiences. If you’re interested, you can expect to share your health history, which will help researchers better understand the outcomes for both mothers and their babies. The trial is currently recruiting participants of all genders and ages. Your involvement could contribute valuable information to improve care for women with SCD and their children.

Gender

ALL

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.

About Children's Hospital Medical Center, Cincinnati

Children's Hospital Medical Center in Cincinnati is a leading pediatric healthcare institution dedicated to advancing child health through innovative clinical research and comprehensive patient care. Renowned for its commitment to excellence, the center conducts a wide range of clinical trials aimed at developing and evaluating new treatments and therapies for pediatric populations. With a focus on multidisciplinary collaboration and ethical research practices, Children's Hospital Medical Center strives to improve health outcomes for children while contributing to the broader scientific understanding of pediatric medicine.

Locations

Cincinnati, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Russell Ware, MD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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