Tracking growth, puberty, fertility, and pregnancy in people with sickle cell anemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a long-term, international observational cohort that follows people with documented sickle cell anemia over time to record development and reproductive outcomes. Participants attend clinic visits every few months for clinical assessments and blood tests, with post-menarche girls having pregnancy tests every six months and boys optionally providing semen samples. The cohort will include people who are and are not taking hydroxyurea, allowing comparison of outcomes by medication exposure while collecting regular self-reported and clinical data. Enrollment generally requires being at least 8 years old and already enrolled in the EXTEND or SACRED studies, with informed consent obtained for ongoing follow-up.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with documented sickle cell anemia (SCA).
* At least 8 years of age at the time of enrollment.
* Enrolled on the EXTEND or SACRED study.
* Provide informed consent.
* Able to take part in all parts of the study, including treatments, check-ups, and follow-up visits.

Exclusion Criteria:

* Currently taking part in another treatment study (not EXTEND or SACRED).
* Has received other treatments for sickle cell disease in the past 6 months.

Where it's running

• Centro de Obstetricia y Ginecologia
  Santo Domingo, Dominican Republic Recruiting
• Caribbean Institute for Health Research, University of West Indies
  Kingston, Jamaica Recruiting
• Buganda Medical Centre
  Mwanza, Tanzania Recruiting

Study contacts

• Principal investigator: Russell E Ware, MD, PhD — Children's Hospital Medical Center, Cincinnati
• Study coordinator: Teresa Latham, DrPh
• Email: Teresa.Latham@cchmc.org
• Phone: 513-803-7822

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.