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| Name | Class |
|---|---|
| The University of The West Indies | OTHER |
| Centro de Obstetricia y Ginecologia Recruiting Santo Domingo, Dominican Republic | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sickle Cell Anemia | Those with sickle cell anemia (SCA). |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcomes | The number of people who experience serious health events like pregnancy, stroke, cancer, or death. | From enrollment up to 10 years after enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Female Reproductive Potential and Outcomes | Female fertility potential will be measured using serum anti-mullerian hormone (physiologic parameter) | From enrollment up to 10 years after enrollment. |
| Female Reproductive Potential and Outcomes |
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Inclusion Criteria:
Exclusion Criteria:
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People with sickle cell anemia who are at least 8 years old and seen in Jamaica and Dominican Republic.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Teresa Latham, DrPh | Contact | 513-803-7822 | Teresa.Latham@cchmc.org | |
| Russell E Ware, MD, PhD | Contact | 513-803-4597 | Russell.Ware@cchmc.org |
| Name | Affiliation | Role |
|---|---|---|
| Russell E Ware, MD, PhD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Obstetricia y Ginecologia | Recruiting | Santo Domingo | Dominican Republic |
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| Label | URL |
|---|---|
| SACRED ClinicalTrials.gov Posting | View source |
| EXTEND ClinicalTrials.gov Posting | View source |
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Study data will be collected and managed using REDCapâ„¢ electronic data capture tools. REDCapâ„¢ is a secure, web-based application designed to support data capture for research studies, providing: 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources. The REDCapâ„¢ system is available for use through institutions participating in the REDCapâ„¢ consortium. Cincinnati Children's Hospital Medical Center serves as the home institution to allow the REDCapâ„¢ system for de-identified data collection in the SAFE study.
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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Whole blood and FTA dried blood spots.
Female ability to conceive will be assessed using incidence of pregnancy (questionnaire)
| 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) | 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) | 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) | 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) | From enrollment up to 10 years after enrollment. |
| Male Reproductive Potential and Outcomes | Male fertility potential will be measured using sperm analysis (physiologic parameter) | 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) | 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) | 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) | 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) | 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) | From enrollment up to 10 years after enrollment. |
| Caribbean Institute for Health Research, University of West Indies | Recruiting | Kingston | Jamaica |
|
| Buganda Medical Centre | Recruiting | Mwanza | Tanzania |
|
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |