Cervical Priming With Misoprostol Prior to Operative Hysteroscopy

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01024270
First received: November 12, 2009
Last updated: November 30, 2009
Last verified: July 2009

November 12, 2009
November 30, 2009
July 2008
July 2009   (final data collection date for primary outcome measure)
The primary outcome measure in this study was the preoperative cervical width after misoprostol administration. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01024270 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Cervical Priming With Misoprostol Prior to Operative Hysteroscopy
Cervical Priming With Misoprostol Prior to Operative Hysteroscopy

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Single Blind (Caregiver)
Cervical Ripening
Drug: Misoprostol
Experimental: sublingual, oral and vaginal administration of misoprostol
Intervention: Drug: Misoprostol
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. Epub 2010 Jun 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
141
July 2009
July 2009   (final data collection date for primary outcome measure)

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.
Female
20 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01024270
2008-06-035
Not Provided
Duk Soo Bae/Chairman of Dept. of Ob. & Gyn, Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Duk Soo Bae, M.D. Samsung Medical Center
Samsung Medical Center
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP