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.
Hydroxyurea is a medicine that helps people with sickle cell anemia (SCA), a serious blood disease. It works by increasing a special type of hemoglobin (called fetal hemoglobin) that helps prevent sickle cell problems. This medicine is especially helpful in places where it's hard to get safe blood transfusions. Studies from around the world have shown that hydroxyurea is safe and can reduce serious health problems caused by SCA (like pain, strokes, and lung issues). It can also help people with SCA live longer, healthier lives. However, the investigators still don't know everything about how hydroxyurea affects long-term growth, puberty, fertility, or pregnancy; especially in areas with fewer medical resources. To learn more, researchers are planning a large international study. They will follow people with SCA over time to see how hydroxyurea affects their development, ability to have children, and pregnancy outcomes. Participants will visit the clinic every few months for check-ups, blood tests, and other health assessments. Girls who have started their periods will take pregnancy tests every six months, and boys may be asked to provide a semen sample if they agree. Everyone will also answer questions about their health and fertility regularly.
Study Type
OBSERVATIONAL
Enrollment
250
Centro de Obstetricia y Ginecologia
Santo Domingo, Dominican Republic
RECRUITINGCaribbean Institute for Health Research, University of West Indies
Kingston, Jamaica
RECRUITINGBuganda Medical Centre
Mwanza, Tanzania
RECRUITINGClinical 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.
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.
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.
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.
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.
Female Reproductive Potential and Outcomes
Prematurity of infant will be categorized as premature or full term (questionnaire)
Time frame: From enrollment up to 10 years after enrollment.
Female Reproductive Potential and Outcomes
Weight of infant will be categorized as normal birth weight or low birth weight (questionnaire)
Time frame: From enrollment up to 10 years after enrollment.
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Male Reproductive Potential and Outcomes
Male fertility potential will be measured using sperm analysis (physiologic parameter)
Time frame: From enrollment up to 10 years after enrollment.
Male Reproductive Potential and Outcomes
Male ability to conceive will be assessed using incidence of impregnated partner (questionnaire)
Time frame: From enrollment up to 10 years after enrollment.
Male 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.
Male 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.
Male Reproductive Potential and Outcomes
Prematurity of infant will be categorized as premature or full term (questionnaire)
Time frame: From enrollment up to 10 years after enrollment.
Male Reproductive Potential and Outcomes
Weight of infant will be categorized as normal birth weight or low birth weight (questionnaire)
Time frame: From enrollment up to 10 years after enrollment.