RecruitingNCT04093986

Hydroxyurea Exposure Limiting Pregnancy and Follow-Up Lactation


Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

200 participants

Start Date

Dec 22, 2019

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Inclusion Criteria2

  • 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 Criteria1

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

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Interventions

OTHERChart 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.

OTHERSurvey

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.


Locations(1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

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NCT04093986


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