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Information about ongoing health services research and public health projects
| Medicine or surgery? (MS?).
(Archived Project) |
|
|---|---|
| Investigator (PI): | Hulley, Stephen B |
| Performing Organization (PO): |
(Current): University of California, San Francisco, School of Medicine, Center for Health and Community |
| Supporting Agency (SA): | Agency for Healthcare Research and Quality (AHRQ) || National Institutes of Health (NIH), National Institute on Aging (NIA) |
| Initial Year: | 1996 |
| Final Year: | 2003 |
| Record Source/Award ID: | CRISP/U01HS09478 |
| Funding: | Total Award Amount: $7,852,990 |
| Award Type: | Grant |
| Award Information: | Reports resulting from this project |
| Abstract: | DESCRIPTION: The proposed study is a randomized clinical trial comparing the effects of enhanced medical therapy vs. hysterectomy on functioning and well-being in premenopausal women with abnormal uterine bleeding who do not respond adequately after three months of initial medical management. A second randomized trial will compare the effects of supracervical vs. total hysterectomy on function and well-being in women who undergo abdominal hysterectomy. Group differences in quality-of-life, clinical, sexual function, and economic outcomes will be examined. Four clinical centers will recruit and screen approximately 3000 premenopausal women, over age 30 with abnormal uterine bleeding, over a two-year period. For this study, abnormal bleeding is defined as more than eight days of menstrual flow per month or anemia (hematocrit <32 percent) in women with heavy flow and no other cause for anemia. Criteria for exclusion include: pregnancy, genital tract or breast malignancy, other indications for hysterectomy or adnexal removal, contraindications to progestins, oral contraceptive pills, or prostaglandin inhibitors, inability to comply with medical regimen or study follow-up, GnRH agonist therapy within 6 months of study entry, and rapid uterine enlargement (doubling over 6 months). Initially, three months of traditional progestin therapy will be administered. Several assumptions are then made to arrive at a sample size of 300 patients, who will be randomized to either medical therapy (oral contraceptive pills and prostaglandin inhibitors) or hysterectomy (abdominal or vaginal, based on clinical judgment of the gynecologist in consultation with the woman). For those patients scheduled to undergo abdominal hysterectomy, a second level of randomization will take place to have either a supracervical or a total hysterectomy. Patients will be followed for two years. |
| MeSH Terms: |
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| Keywords: |
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| Country: | United States |
| State: | California |
| Zip Code: | 94105 |
| UI: | 97102750 |
| Project Status: | Archived |
| Record History: | ('1997-2000: NIA contributed funding.',) |
