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
  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

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • The primary outcome measure in this study was the preoperative cervical width after misoprostol administration. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024270

Locations
Korea, Republic of
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
  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 April 14, 2014