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Cervical Priming With Misoprostol Prior to Operative Hysteroscopy

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ClinicalTrials.gov Identifier: NCT01024270
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : December 2, 2009
Sponsor:
Information provided by:
Samsung Medical Center

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
Cervical Ripening Drug: Misoprostol Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Randomized
Masking: Single (Care Provider)
Official Title: Cervical Priming With Misoprostol Prior to Operative Hysteroscopy
Study Start Date : July 2008
Primary Completion Date : July 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol
U.S. FDA Resources

Arm Intervention/treatment
Experimental: sublingual, oral and vaginal administration of misoprostol Drug: Misoprostol



Primary Outcome Measures :
  1. The primary outcome measure in this study was the preoperative cervical width after misoprostol administration. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Duration of cervical dilatation, up to Hegar number 10. [ Time Frame: 1 year ]
  2. Complications during cervical dilation. [ Time Frame: 1 year ]
  3. Misoprostol associated side effects. [ Time Frame: 1 year ]
  4. Complications during the hysteroscopy. [ Time Frame: 1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: December 2, 2009
Last Verified: July 2009

Keywords provided by Samsung Medical Center:
endometrial pathology of uterus
operative hysteroscopy
efficacy of misoprostol per different routes

Additional relevant MeSH terms:
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics