Hydroxyurea Exposure Limiting Pregnancy and Follow-Up Lactation

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT04093986
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Dec 22, 2019
Status verified
Jul 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Teresa Latham
[email protected]
513-803-7922
Rebecca Geer
[email protected]

Find similar trials in Cincinnati, OH

By condition
Sickle cell disease
By research site
Cincinnati Children's Hospital Medical Center· Cincinnati, OH

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