Global Study of Women's Health

NCT00849173 | Completed

• 2 other identifiers: 09008509-CH-0085
• Study Type: observational
• Target: 1,459
• Locations: 1 country
• Sites: 1

Brief Summary

Endometriosis, a condition in which the lining of the uterus grows on nearby tissues, is a common condition that affects women of reproductive age worldwide. The diagnosis of endometriosis is usually made at surgery. The most common symptom is pelvic pain. This pain may occur at the same time as menstrual bleeding, at other times of the cycle, or during or after sexual intercourse. Previous studies reveal the diagnosis of endometriosis is often delayed between 8 and 12 years after the first symptoms. Women with chronic pelvic pain report a lower quality of life. No studies, however, have been conducted to assess whether women with endometriosis-related pelvic pain are affected differently than those with pelvic pain from other or no identifiable causes. This large-scale study is designed to gather prospective epidemiological data on the impact of and risk factors for endometriosis across countries worldwide. A study of this scale and scope has never been performed; it is anticipated that the study will provide novel insights into the effects of the condition and associated symptoms on women s lives across different countries, as well as explore differences in the effects of various potential risk factors. This is an international study conducted at more than 20 sites worldwide and coordinated by Oxford University in the United Kingdom. At the National Institutes of Health, 250 premenopausal women between 18 and 45 years of age who are having their first diagnostic laparoscopy or laparoscopy for tubal sterilization will participate. None will have had a prior diagnosis of endometriosis through surgery. Women will be informed about the study when their laparoscopy is scheduled. Procedures

• Patient completion of an online questionnaire before scheduled surgery. The following will be assessed by the questionnaire:
• Quality of life
• General gynecologic and medical history
• Family history
• General information
• Use of health care services
• Risk factors
• Surgeon completion of questionnaire about surgical findings.
• Follow-up: Women who consent will be contacted every 1 2 years.

Conditions

Endometriosis; Infertility; Chronic Pelvic Pain; Tubal Ligation

Keywords

Endometriosis; Infertility; Tubal Ligation; Chronic Pelvic Pain; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Impact of endometriosis among women worldwide

Secondary Outcomes (1)

• Provide a frame-work for future studies of women diagnosed with endometriosis which collect long term quality of life issues as well as personal and economic costs of endometriosis.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A patient who meets all of the following criteria is eligible for the study:
• Premenopausal female 18 to 45 years of age
• Attending for her first diagnostic laparoscopy or for laparoscopy for tubal sterilisation
• Has no previous history of endometriosis diagnosis through surgery

You may not qualify if:

• A patient who meets any of the following criteria is ineligible for the study:
• Already has a surgically-confirmed diagnosis of endometriosis
• Aged less than18 or greater than 45
• Aged 18-45 but post-menopausal

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Endometriosis; Infertility

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Pamela Stratton, M.D.

  Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 20, 2009
• First Posted: February 23, 2009
• Study Start: February 17, 2009
• Study Completion: November 26, 2012
• Last Updated: April 5, 2018

Record last verified: 2012-11-26

Locations

US (1)