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Completed

NCT Number: NCT01024270

Cervical Priming With Misoprostol Prior to Operative Hysteroscopy

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.

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Key information

Conditions

Age range

20 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Misoprostol

Drug

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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 2, 2009
Registry last updated
Dec 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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