Cervical Priming With Misoprostol Prior to Operative Hysteroscopy

NCT01024270 | Completed Phase 3

• 1 other identifier: 2008-06-035
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Ripening

Keywords

endometrial pathology of uterus; operative hysteroscopy; efficacy of misoprostol per different routes

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure in this study was the preoperative cervical width after misoprostol administration.

  1 year

Secondary Outcomes (4)

• 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

Study Arms (1)

sublingual, oral and vaginal administration of misoprostol

EXPERIMENTAL

Drug: Misoprostol

Interventions

Misoprostol DRUG

sublingual, oral and vaginal administration of misoprostol

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

• Lee YY, Kim TJ, Kang H, Choi CH, Lee JW, Kim BG, Bae DS. The use of misoprostol before hysteroscopic surgery in non-pregnant premenopausal women: a randomized comparison of sublingual, oral and vaginal administrations. Hum Reprod. 2010 Aug;25(8):1942-8. doi: 10.1093/humrep/deq083. Epub 2010 Jun 11.

  PMID: 20542898 DERIVED

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Duk Soo Bae, M.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 12, 2009
• First Posted: December 2, 2009
• Study Start: July 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: December 2, 2009

Record last verified: 2009-07

Locations

KR (1)