Sickle Cell Disease Trial, Recruiting NCT04093986 Sponsor: Children's Hospital Medical Center, Cincinnati Condition: Sickle Cell Disease
Back to Sickle Cell Disease

Sickle Cell Disease Trial, Recruiting

NCT04093986
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People whose medical records from before June 20, 2019 show they were pregnant and had sickle cell disease (a blood disorder), including those whose pregnancy ended in miscarriage, stillbirth, or delivery at any stage of pregnancy, and who were exposed to a medication called hydroxyurea at any point during the pregnancy or while breastfeeding.
  • People whose medical records from before June 20, 2019 include information about pregnancy and breastfeeding outcomes — both for babies who were exposed to hydroxyurea and for other babies born to the same women.

Who may not be able to join:

  • People whose medical records are unavailable or do not contain enough information about whether hydroxyurea was used during pregnancy or breastfeeding.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Russell Ware, MD, Children's Hospital Medical Center, Cincinnati

Phone: 513-803-7922

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
22 December 2019
Est. completion
31 December 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

How long pregnant women with Sickle Cell Disease (SCD) were exposed to Hydroxyurea.; Dose of hydroxyurea taken during pregnancy.; How long infants were exposed to Hydroxyurea.; Dose of hydroxyurea exposure in infants.; Health outcomes of infants exposed to Hydroxyurea.; Pregnancy in Sickle Cell Disease (SCD).; Comparative analysis of congenital malformations or medical conditions in infants

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov