Cervical Priming With Misoprostol Prior to Operative Hysteroscopy

Cervical Ripening Clinical Trial

Official title:

Cervical Priming With Misoprostol Prior to Operative Hysteroscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01024270
• Other study ID #: 2008-06-035
• Status: Completed
• Phase: Phase 3
• First received: November 12, 2009
• Last updated: November 30, 2009
• Start date: July 2008
• Est. completion date: July 2009

Study information

• Verified date: July 2009
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Single Blind (Caregiver)

Related Conditions & MeSH terms

• Cervical Ripening

Intervention

Drug:
• Misoprostol

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure in this study was the preoperative cervical width after misoprostol administration.		1 year	No
Secondary	Duration of cervical dilatation, up to Hegar number 10.		1 year	No
Secondary	Complications during cervical dilation.		1 year	No
Secondary	Misoprostol associated side effects.		1 year	No
Secondary	Complications during the hysteroscopy.		1	No