Postpartum Uterine Regression

NCT00341848 | Completed

• 2 other identifiers: 99990207502-E-N075
• Study Type: observational
• Target: 374
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uterine Leiomyoma

Keywords

Apoptosis; Environment; Infection; Inflammation; Leiomyoma; Uterine Leiomyoma; Uterus

Outcome Measures

Primary Outcomes (1)

• Monitor fibroids

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (1)

NIEHS, Research Triangle Park

Research Triangle Park, North Carolina, 27709, United States

Location

Related 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. doi: 10.1089/jwh.1997.6.309.

  PMID: 9201665 BACKGROUND

• Cramer SF, Patel A. The frequency of uterine leiomyomas. Am J Clin Pathol. 1990 Oct;94(4):435-8. doi: 10.1093/ajcp/94.4.435.

  PMID: 2220671 BACKGROUND

• 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. doi: 10.1093/aje/153.1.20.

  PMID: 11159141 BACKGROUND

MeSH Terms

Conditions

Myofibroma; Infections; Inflammation; Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Muscle Tissue

Study Officials

• Donna D Baird, Ph.D.

  National Institute of Environmental Health Sciences (NIEHS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: December 6, 2001
• Study Completion: June 13, 2019
• Last Updated: June 17, 2019

Record last verified: 2019-06-13

Locations

US (1)