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CompletedNCT01024270Updated Dec 2, 2009

Cervical Priming With Misoprostol Prior to Operative Hysteroscopy

A Phase 3 interventional study of Misoprostol in Cervical Ripening, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to female participants aged 20 Years to 55 Years. Per ClinicalTrials.gov, last updated 2009-12-02.

Sponsored by Samsung Medical Center · Phase 3 and Interventional

Phase
Phase 3
Study type
Interventional
Enrollment
141
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Cervical Ripening

Keywords

  • endometrial pathology of uterus
  • operative hysteroscopy
  • efficacy of misoprostol per different routes
03

In context

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 3
Allocation
Randomized
Masking
Single (Care provider)
Enrollment
141 participants (actual)

Study arms

  • Experimental
    sublingual, oral and vaginal administration of misoprostol

    Drug: Misoprostol

Interventions

  • DrugMisoprostol
06

What researchers measure

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

  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

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, 135-710, Korea, Republic of
08

References and documents

Publications

  • 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. PubMed 20542898 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01024270
Lead sponsor
Samsung Medical Center
First posted
Dec 2, 2009
Start date
Jul 2008
Primary completion
Jul 2009
Completion
Jul 2009
Last update
Dec 2, 2009

Study contacts

Duk Soo Bae, M.D.
principal investigator · Samsung Medical Center
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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