Cervical Priming With Misoprostol Prior to Operative Hysteroscopy
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Cervical Ripening |
Drug: Misoprostol |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Masking: Single Blind (Caregiver) |
| Official Title: | Cervical Priming With Misoprostol Prior to Operative Hysteroscopy |
- The primary outcome measure in this study was the preoperative cervical width after misoprostol administration. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Duration of cervical dilatation, up to Hegar number 10. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Complications during cervical dilation. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Misoprostol associated side effects. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Complications during the hysteroscopy. [ Time Frame: 1 ] [ Designated as safety issue: No ]
| Enrollment: | 141 |
| Study Start Date: | July 2008 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: sublingual, oral and vaginal administration of misoprostol | Drug: Misoprostol |
Eligibility| Ages Eligible for Study: | 20 Years to 55 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
More Information
No publications provided by Samsung Medical Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Duk Soo Bae/Chairman of Dept. of Ob. & Gyn, Samsung Medical Center |
| ClinicalTrials.gov Identifier: | NCT01024270 History of Changes |
| Other Study ID Numbers: | 2008-06-035 |
| Study First Received: | November 12, 2009 |
| Last Updated: | November 30, 2009 |
| Health Authority: | South Korea: Institutional Review Board |
Keywords provided by Samsung Medical Center:
|
endometrial pathology of uterus operative hysteroscopy efficacy of misoprostol per different routes |
Additional relevant MeSH terms:
|
Misoprostol Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
Oxytocics Reproductive Control Agents Physiological Effects of Drugs Abortifacient Agents, Nonsteroidal Abortifacient Agents |
ClinicalTrials.gov processed this record on May 23, 2013