Uterine Fibroid Pregnancy Registry

June 29, 2021 updated by: Syneos Health

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.

Study Overview

Status

Terminated

Conditions

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, 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.

Study Type

Observational

Enrollment

2360

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Syneos Health

Investigators

  • Study Director: Susan S Roberts, PhD, Syneos Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

October 3, 2005

First Submitted That Met QC Criteria

October 3, 2005

First Posted (Estimate)

October 5, 2005

Study Record Updates

Last Update Posted (Actual)

July 1, 2021

Last Update Submitted That Met QC Criteria

June 29, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFB04-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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