Serial Assessment of Fertility Experiences
ConditionSickle Cell Anemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8+
SponsorChildren's Hospital Medical Center, Cincinnati
About this trial
The SAFE study is a long-term research project that watches people with sickle cell anemia (SCA) over time. The main goal is to see how a medicine called hydroxyurea affects their growth, puberty, and ability to have children. A second goal is to see how hydroxyurea affects pregnancy outcomes, by comparing people who take the medicine to those who don't.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Currently taking part in another treatment study (not EXTEND or SACRED).
Has received other treatments for sickle cell disease in the past 6 months.
Trial population
People with sickle cell anemia who are at least 8 years old and seen in Jamaica and Dominican Republic.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
250 Participants
are grouped into 1 trial groupGroup A: Sickle Cell Anemia
Trial outcomes
Primary outcomes
1
Clinical Outcomes
The number of people who experience serious health events like pregnancy, stroke, cancer, or death.
Time frame
From enrollment up to 10 years after enrollment.Secondary outcomes
1
Female Reproductive Potential and Outcomes
Female fertility potential will be measured using serum anti-mullerian hormone (physiologic parameter)
Time frame
From enrollment up to 10 years after enrollment.2
Female Reproductive Potential and Outcomes
Female ability to conceive will be assessed using incidence of pregnancy (questionnaire)
Time frame
From enrollment up to 10 years after enrollment.3
Female Reproductive Potential and Outcomes
Outcomes of pregnancy will be categorized as either abortion or live birth (questionnaire)
Time frame
From enrollment up to 10 years after enrollment.4
Female Reproductive Potential and Outcomes
Mode of delivery will be categorized as vaginal or c-section (questionnaire)
Time frame
From enrollment up to 10 years after enrollment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital Medical Center, Cincinnati
Lead sponsor
The University of The West Indies
Collaborator
Centro de Obstetricia y Ginecologia Recruiting Santo Domingo, Dominican Republic
Collaborator
Source ClinicalTrials.gov