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Sponsored by: |
Kendle International |
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Information provided by: | Kendle International |
ClinicalTrials.gov Identifier: | NCT00232713 |
The Uterine Fibroid Pregnancy Registry is a USA and European-based registry designed to monitor pregnancies in women with uterine fibroids in order to
Those pregnant women exposed to various therapies used to treat uterine fibroids will be compared with those not exposed to treatment in order to detect any potential increase in the risk of major birth defects.
Study Type: | Observational |
Study Design: | Natural History, Longitudinal, Defined Population, Prospective Study |
Estimated Enrollment: | 2360 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | December 2005 |
This is a prospective, observational, registration and follow-up study of patients with uterine fibroids who become pregnant and their offspring. Those who are exposed to treatment at any time during pregnancy or within one month of conception will be compared with those not exposed to treatment.
Enrollment of patients into the Registry may be initiated by health care providers and/or pregnant patients. Health care providers provide all information related to the pregnancy and the outcome.
During the study, data will be collected on uterine fibroids, exposure to treatment for uterine fibroids, potential confounding factors, and pregnancy outcome. Reported cases will be reviewed and classified according to type of birth defects. Registry enrollment is voluntary and should occur as early in pregnancy as possible, preferably before any prenatal testing. Midway between enrollment and the expected date of delivery, the Registry conducts a short interim follow-up with the health care provider to supplement registration data. Near the estimated date of delivery, the Registry prompts the health care provider to provide pregnancy outcome data. The data elements requested include:
If a live birth is reported, the Registry conducts the follow-up with the infant's health care provider within 2 months of birth, and at 12 months of age. If a birth defect is indicated, the Registry will request additional targeted follow-up information from the health care provider. Data on any adverse event will be forwarded to the Sponsors.
Ages Eligible for Study: | 20 Years to 55 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Study ID Numbers: | AFB04-101 |
Study First Received: | October 3, 2005 |
Last Updated: | August 29, 2006 |
ClinicalTrials.gov Identifier: | NCT00232713 History of Changes |
Health Authority: | United States: Institutional Review Board |
Birth Defects Pregnancy Uterine Fibroids Fibroids |
Neoplasms, Connective and Soft Tissue Myofibroma Connective Tissue Diseases Congenital Abnormalities Leiomyoma |
Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Neoplasms Myofibroma Neoplasms by Histologic Type |
Connective Tissue Diseases Neoplasms, Connective Tissue Congenital Abnormalities Leiomyoma |