Hydroxyurea Exposure Limiting Pregnancy and Follow-Up Lactation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorChildren's Hospital Medical Center, Cincinnati
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Unavailable medical records or lack of information about hydroxyurea exposure.
Trial population
Clinical and laboratory data on up to 200 women with SCD with hydroxyurea exposure during either gestation or lactation.
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
Chart Review
Other interventionMedical 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 interventionWomen 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Retrospective Chart Review1 intervention
Group B: Participant Survey and Retrospective Chart Review2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Through completion of pregnancy, an average of 2 years2
Dose of hydroxyurea taken during pregnancy.
Obtain data on the dose of Hydroxyurea taken prior to conception, during and after pregnancy.
Time frame
Through completion of pregnancy, an average of 2 years3
How long infants were exposed to Hydroxyurea.
Obtain data on length of time infants were exposed to Hydroxyurea during gestation and while breastfeeding.
Time frame
Through study completion, an average of 2 years4
Dose of hydroxyurea exposure in infants.
Obtain data on the dose of Hydroxyurea taken by mother during gestation and while breastfeeding infant.
Time frame
Through study completion, an average of 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital Medical Center, Cincinnati
Lead sponsor
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
Source ClinicalTrials.gov