Recruiting

Hydroxyurea

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT04093986

Conditions

Sickle Cell Disease

Sickle Cell Anemia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Chart Review

Survey

Study Details

Brief 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

Sickle Cell Disease

Sickle Cell Anemia

Study ID

NCT04093986

Start date

Dec 22, 2019

Status verified date

Jun, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Retrospective Chart Review

Medical record chart review of women seen previously for clinical care prior to June 20, 2019 at participating institutions with SCD and hydroxyurea exposure during gestation or lactation will be identified by healthcare providers.

Participant Survey and Retrospective Chart Review

Participants providing their medical records without the assistance of a health care provider will be asked to complete a questionnaire through REDCap and will have the option to upload their deidentified medical records if they are available.

Interventions

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.

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.

Primary outcome measure

  • How long pregnant women with Sickle Cell Disease (SCD) were exposed to Hydroxyurea. [ Time Frame: Through completion of pregnancy, an average of 2 years ]
  • Dose of hydroxyurea taken during pregnancy. [ Time Frame: Through completion of pregnancy, an average of 2 years ]
  • How long infants were exposed to Hydroxyurea. [ Time Frame: Through study completion, an average of 2 years ]
  • Dose of hydroxyurea exposure in infants. [ Time Frame: Through study completion, an average of 2 years ]
  • Health outcomes of infants exposed to Hydroxyurea. [ Time Frame: Through study completion, an average of 2 years ]
  • Pregnancy in Sickle Cell Disease (SCD). [ Time Frame: Start of pregnancy until June 2019 ]
  • Comparative analysis of congenital malformations or medical conditions in infants [ Time Frame: Through study completion, an average of 2 years ]

Central Contacts and Locations

Central contacts

Teresa Latham

513-803-7922Teresa.Latham@cchmc.org

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Teresa Latham

513-803-7922Teresa.Latham@cchmc.org

Rebecca Geer

Rebecca.Geer@cchmc.org

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

  • Hydroxyurea

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-06-18.