Hydroxyurea Exposure Limiting Pregnancy and Follow-Up Lactation

NCT04093986 | Recruiting

• 1 other identifier: HELPFUL
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

Hydroxyurea

Outcome Measures

Primary Outcomes (7)

• How long pregnant women with Sickle Cell Disease (SCD) were exposed to Hydroxyurea.

  Obtain data on length of time women with SCD were exposed to Hydroxyurea prior to pregnancy, during pregnancy, and after pregnancy.

  Through completion of pregnancy, an average of 2 years

• Dose of hydroxyurea taken during pregnancy.

  Obtain data on the dose of Hydroxyurea taken prior to conception, during and after pregnancy.

  Through completion of pregnancy, an average of 2 years

• How long infants were exposed to Hydroxyurea.

  Obtain data on length of time infants were exposed to Hydroxyurea during gestation and while breastfeeding.

  Through study completion, an average of 2 years

• Dose of hydroxyurea exposure in infants.

  Obtain data on the dose of Hydroxyurea taken by mother during gestation and while breastfeeding infant.

  Through study completion, an average of 2 years

• Health outcomes of infants exposed to Hydroxyurea.

  Obtain data on the health of infant after exposure to Hydroxyurea during gestation and while breastfeeding including any complications of mother's pregnancy or delivery as well as any congenital malformations or medical conditions in infancy.

  Through study completion, an average of 2 years

• Pregnancy in Sickle Cell Disease (SCD).

  Compare pregnancy and delivery complications in women with SCD exposed to Hydroxyurea to pregnancy and delivery complications in women with SCD without Hydroxyurea exposure.

  Start of pregnancy until June 2019

• Comparative analysis of congenital malformations or medical conditions in infants

  Compare the rate of congenital malformations and/or medical conditions in infants exposed to hydroxyurea during gestation and breastfeeding to the rate of these events in infants without hydroxyurea exposure, with data collected descriptively by self-report or chart review as applicable.

  Through study completion, an average of 2 years

Study Arms (2)

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.

Other: Chart Review

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.

Other: Chart Review; Other: Survey

Interventions

Chart Review OTHER

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.

Participant Survey and Retrospective Chart Review; Retrospective Chart Review

Survey OTHER

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.

Participant Survey and Retrospective Chart Review

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clinical and laboratory data on up to 200 women with SCD with hydroxyurea exposure during either gestation or lactation.

You may qualify if:

• 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.

You may not qualify if:

• Unavailable medical records or lack of information about hydroxyurea exposure.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• University of Connecticut: collaborator
• University of Colorado, Denver: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• Duke University: collaborator
• Children's Hospital of Philadelphia: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Russell Ware, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Teresa Latham

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: September 18, 2019
• Study Start: December 22, 2019
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Locations

US (1)