Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT00232713 |
Other study ID # |
AFB04-101 |
Secondary ID |
|
Status |
Terminated |
Phase |
|
First received |
|
Last updated |
|
Start date |
December 2005 |
Est. completion date |
December 2005 |
Study information
Verified date |
June 2021 |
Source |
Syneos Health |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The Uterine Fibroid Pregnancy Registry is a USA and European-based registry designed to
monitor pregnancies in women with uterine fibroids in order to
1. estimate the risk ratio of birth defects in women with uterine fibroids who were treated
or untreated during pregnancy and
2. detect any pattern of birth defects among pregnancies in specific treatment groups.
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.
Description:
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:
- Health care provider contact information
- Eligibility criteria
- Uterine fibroid treatment (30 days prior to conception and during pregnancy and includes
non-steroidal anti-inflammatory drugs, oral contraceptive pills, progestational agents,
gonadotropin-releasing hormone (GnRH) agonists, and other oral agents)
- Pregnancy/Birth outcome
- Maternal information
- Prenatal tests
- Uterine fibroid classification
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.