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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00341848
Other study ID # 999902075
Secondary ID 02-E-N075
Status Completed
Phase
First received
Last updated
Start date December 6, 2001
Est. completion date June 13, 2019

Study information

Verified date June 13, 2019
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Uterine leiomyomas are the leading cause of hysterectomy in the United States, accounting for over 200,000 procedures each year. Most epidemiologic studies of uterine leiomyoma show that parity has a protective association with leiomyoma, but the mechanism is not known. Both epidemiologic data and data from an animal model indicate that the protective association is not an artifact resulting from reduced fertility among women with fibroids. We hypothesize that the process of uterine regression following delivery results in loss of small fibroids due to selective apoptosis of transformed cells and the extensive remodeling of the entire uterus.


Description:

Background: Uterine leiomyomas are the leading cause of hysterectomy in the United States, accounting for over 200,000 procedures each year. Most epidemiologic studies of uterine leiomyoma show that parity has a protective association with leiomyoma, but the mechanism is not known. Both epidemiologic data and data from an animal model indicate that the protective association is not an artifact resulting from reduced fertility among women with fibroids. We hypothesize that the process of uterine regression following delivery results in loss of small fibroids due to selective apoptosis of transformed cells and the extensive remodeling of the entire uterus.

Study Objectives: Monitor fibroids during pregnancy and after postpartum uterine regression to assess any loss of fibroids and change in size of fibroids.

Methods: Add a postpartum ultrasound examination to an existing epidemiologic study of pregnant women. The parent study documents fibroid number, size, and location with a 7 week ultrasound examination. With the additional postpartum ultrasound proposed here, data on fibroid number, size, and location through pregnancy and postpartum uterine regression will be collected on approximately 400 women. A subsample of 30 women will also have an MRI after their postpartum ultrasound in order to evaluate the sensitivity of ultrasound imaging.

Significance: This study will provide the first data on fibroid change with parturition/postpartum uterine regression for a large sample of women. If small fibroids disappear during this time, it will document a process that results in "natural regression" of these tumors in premenopausal women. Insights from the biology of this process may be useful in developing treatment that could be used by nonpregnant women with fibroids to induce tumor regression.


Recruitment information / eligibility

Status Completed
Enrollment 374
Est. completion date June 13, 2019
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility - INCLUSION CRITERIA:

Participants in the Right From The Start Study must be 18 years old or older, pregnant, enrolled by 10 weeks of gestation, planning to carry pregnancy to term, no plans to move before delivery, and English speaking. Those who are found to have fibroids at either their 7-week, or 22-week ultrasound examination are eligible for this further postpregnancy study.

A small substudy of 30 women having MRIs to evaluate the sensitivity of the ultrasound imaging will include only participants with a single fibroid found at the early pregnancy ultrasound.

EXCLUSION CRITERIA FOR MRI:

Exclusion criteria for the MRI are weight greater than 250 pounds, currently pregnant, metal of specific types in the body (an artificial hip, a clip for brain aneurysm, a medical implant in the ear, metal fragment in the eye, or a pacemaker), history of claustrophobia, previous severe reaction to MRI contrast, and chronic kidney disease. A severe reaction would consist of bronchospasm (shortness of breath/difficulty breathing) or shock (sudden loss of blood pressure). Risk is less than 1/100,000 with Gd based contrast material. Any potential subject with a history of kidney disease will be excluded from the study.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States NIEHS, Research Triangle Park Research Triangle Park North Carolina

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Brett KM, Marsh JV, Madans JH. Epidemiology of hysterectomy in the United States: demographic and reproductive factors in a nationally representative sample. J Womens Health. 1997 Jun;6(3):309-16. — View Citation

Chen CR, Buck GM, Courey NG, Perez KM, Wactawski-Wende J. Risk factors for uterine fibroids among women undergoing tubal sterilization. Am J Epidemiol. 2001 Jan 1;153(1):20-6. — View Citation

Cramer SF, Patel A. The frequency of uterine leiomyomas. Am J Clin Pathol. 1990 Oct;94(4):435-8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Monitor fibroids
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