Uterine Fibroid Pregnancy Registry

This study has been terminated.
Sponsor:
Information provided by:
INC Research
ClinicalTrials.gov Identifier:
NCT00232713
First received: October 3, 2005
Last updated: August 29, 2006
Last verified: February 2006
  Purpose

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.


Condition Phase
Birth Defects
Pregnancy
Uterine Fibroids
Phase 4

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal

Further study details as provided by INC Research:

Estimated Enrollment: 2360
Study Start Date: December 2005
Estimated Study Completion Date: December 2005
Detailed 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, 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.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient is currently pregnant or report is a retrospective defect
  • Patient was diagnosed with uterine fibroids prior to becoming pregnant
  • Patient is between the ages of 20 and 55
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232713

Sponsors and Collaborators
INC Research
Investigators
Study Director: Susan S Roberts, PhD INC Research
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00232713     History of Changes
Other Study ID Numbers: AFB04-101
Study First Received: October 3, 2005
Last Updated: August 29, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by INC Research:
Birth Defects
Pregnancy
Uterine Fibroids
Fibroids

Additional relevant MeSH terms:
Congenital Abnormalities
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on July 26, 2014