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Phase 4
20 Years
55 Years
Not Enrolling
Birth Defects, Pregnancy, Uterine Fibroids

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Trial Information

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.

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

Type of Study:


Study Design:

Observational Model: Defined Population, Observational Model: Natural History, Time Perspective: Longitudinal, Time Perspective: Prospective

Principal Investigator

Susan S Roberts, PhD

Investigator Role:

Study Director

Investigator Affiliation:

INC Research


United States: Institutional Review Board

Study ID:




Start Date:

December 2005

Completion Date:

December 2005

Related Keywords:

  • Birth Defects
  • Pregnancy
  • Uterine Fibroids
  • Birth Defects
  • Pregnancy
  • Uterine Fibroids
  • Fibroids
  • Congenital Abnormalities
  • Leiomyoma
  • Myofibroma