Cervical Priming With Misoprostol Prior to Operative Hysteroscopy

Phase 3

Completed

• Conditions: Cervical Ripening
• Interventions: Drug: Misoprostol

• Registration Number: NCT01024270
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Status Verified: 2009-07
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Study First Submitted: 2009-11-12
• Study First Submitted QC: 2009-11-30
• Last Update Submitted: 2009-11-30
• Study First Posted: 2009-12-02
• Last Update Posted: 2009-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 141

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
sublingual, oral and vaginal administration of misoprostol	Misoprostol	-

Primary Outcome Measures

Name	Time	Method
The primary outcome measure in this study was the preoperative cervical width after misoprostol administration.	1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of