Cervical Priming With Misoprostol Prior to Operative Hysteroscopy
Study Details
Study Description
Brief Summary
The primary outcome measure in this study was the preoperative cervical width after misoprostol administration. The secondary outcomes were duration of cervical dilatation, up to Hegar number 10, complications during cervical dilation and the hysteroscopy, and misoprostol associated side effects. The cervical width was assessed by performing cervical dilatation, starting with a number 10 Hegar dilator and subsequently inserting smaller Hegar dilatators until the dilator could pass through the internal os without resistance. The largest one that could be passed was recorded as the initial cervical width.
The mean cervical diameter, after oral and vaginal misoprostol of 400 μg, has been reported to be 6.0 ± 1.5 mm and 7.3 ± 1.6 mm, respectively 4. The investigators hypothesized that equivalence was of clinical significance if the difference in the initial cervical width was less than 1 mm among groups with the standard deviation of the initial cervical width of 1.6 mm. The estimated sample size was 47 patients in each group; this would be able to detect an equivalent effect in the groups with a power of 80% and a type 1 error (a) of 0.017. Data are expressed as the mean ± SD (standard deviation) or median with range or as the number (%) of cases.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: sublingual, oral and vaginal administration of misoprostol
|
Drug: Misoprostol
|
Outcome Measures
Primary Outcome Measures
- The primary outcome measure in this study was the preoperative cervical width after misoprostol administration. [1 year]
Secondary Outcome Measures
- Duration of cervical dilatation, up to Hegar number 10. [1 year]
- Complications during cervical dilation. [1 year]
- Misoprostol associated side effects. [1 year]
- Complications during the hysteroscopy. [1]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Symptomatic patients that were suspected as having intrauterine pathology such as submucosal myoma, endometrial polyps or other endometrial pathological findings based on the transvaginal ultrasound were enrolled.
-
women who are more than 20 years of age with having sexual contact history
-
women whose last menstrual period are within the last two months.
Exclusion Criteria:
-
Post menopausal women
-
any evidence of a contraindication or allergy to PGs
-
any sign of genital infection, history of cervical surgery, endometrial lesions with suspected endo- or exocervical lesions that could affect the cervical resistance or patients that were not candidates for surgery.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Samsung Medical Center | Seoul | Korea, Republic of | 135-710 |
Sponsors and Collaborators
- Samsung Medical Center
Investigators
- Principal Investigator: Duk Soo Bae, M.D., Samsung Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2008-06-035