MedTrace Logo

Hydroxyurea Exposure Limiting Pregnancy and Follow-Up Lactation

NCT04093986 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-07-17

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Chart 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.

OTHER

Survey

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.

Sponsors & Collaborators

  • University of Connecticut

    collaborator OTHER

  • University of Colorado, Denver

    collaborator OTHER

  • Guy's and St Thomas' NHS Foundation Trust

    collaborator OTHER

  • Duke University

    collaborator OTHER

  • Children's Hospital of Philadelphia

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Russell Ware, MD · Children's Hospital Medical Center, Cincinnati

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-22
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04093986 on ClinicalTrials.gov