NCT04093986 · Children's Hospital Medical Center, Cincinnati
Hydroxyurea Exposure Limiting Pregnancy and Follow-Up Lactation
(HELPFUL)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
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.
OTHER
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 measures
How long pregnant women with Sickle Cell Disease (SCD) were exposed to Hydroxyurea.
Time frame: Through completion of pregnancy, an average of 2 years
Obtain data on length of time women with SCD were exposed to Hydroxyurea prior to pregnancy, during pregnancy, and after pregnancy.
Dose of hydroxyurea taken during pregnancy.
Time frame: Through completion of pregnancy, an average of 2 years
Obtain data on the dose of Hydroxyurea taken prior to conception, during and after pregnancy.
How long infants were exposed to Hydroxyurea.
Time frame: Through study completion, an average of 2 years
Obtain data on length of time infants were exposed to Hydroxyurea during gestation and while breastfeeding.
Dose of hydroxyurea exposure in infants.
Time frame: Through study completion, an average of 2 years
Obtain data on the dose of Hydroxyurea taken by mother during gestation and while breastfeeding infant.
Health outcomes of infants exposed to Hydroxyurea.
Time frame: Through study completion, an average of 2 years
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.
Pregnancy in Sickle Cell Disease (SCD).
Time frame: Start of pregnancy until June 2019
Compare pregnancy and delivery complications in women with SCD exposed to Hydroxyurea to pregnancy and delivery complications in women with SCD without Hydroxyurea exposure.
Comparative analysis of congenital malformations or medical conditions in infants
Time frame: Through study completion, an average of 2 years
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Cincinnati, Ohio
Collaborators
University of Connecticut, University of Colorado, Denver, Guy's and St Thomas' NHS Foundation Trust, Duke University, Children's Hospital of Philadelphia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 18, 2026 · Source of record for eligibility and locations