Clinical trial NCT01024270: Cervical Priming With Misoprostol Prior to Operative Hysteroscopy
Official title: Cervical Priming With Misoprostol Prior to Operative Hysteroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Ripening
Keywords: endometrial pathology of uterus
operative hysteroscopy
efficacy of misoprostol per different routes
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2009-12-02
Enrollment: 141
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED

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.


Eligibility 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.

Primary outcomes:
measure: The primary outcome measure in this study was the preoperative cervical width after misoprostol administration.
timeFrame: 1 year
Secondary outcomes:
measure: Duration of cervical dilatation, up to Hegar number 10.
timeFrame: 1 year
measure: Complications during cervical dilation.
timeFrame: 1 year
measure: Misoprostol associated side effects.
timeFrame: 1 year
measure: Complications during the hysteroscopy.
timeFrame: 1
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Duk Soo Bae, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1093/humrep/deq083. Epub 2010 Jun 11.