NCT00232713

Brief 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. 1.estimate the risk ratio of birth defects in women with uterine fibroids who were treated or untreated during pregnancy and
  2. 2.detect any pattern of birth defects among pregnancies in specific treatment groups.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2005

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

July 1, 2021

Status Verified

June 1, 2021

First QC Date

October 3, 2005

Last Update Submit

June 29, 2021

Conditions

Birth DefectsPregnancyUterine Fibroids

Keywords

Birth DefectsPregnancyUterine FibroidsFibroids

Eligibility Criteria

Age20 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Congenital AbnormalitiesLeiomyoma

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Susan S Roberts, PhD

    Syneos Health

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2005

First Posted

October 5, 2005

Study Start

December 1, 2005

Study Completion

December 1, 2005

Last Updated

July 1, 2021

Record last verified: 2021-06