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Completed

NCT Number: NCT01805115

Misoprostol Administration Before Operative Hysteroscopy

The objective of this study is to compare the efficacy of oral, sublingual, vaginal, and no misoprostol prior to operative hysteroscopy in premenopausal women.

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

CHA Gangnam Medical Center

Seoul, 135-081, South Korea

About this study

The route of administration of misoprostol for cervical dilatation prior to operative hysteroscopy can be oral, vaginal, or sublingual. However, it is still unclear which route is more effective and less harmful for cervical dilation prior to operative hysteroscopy in premenopausal women. Furthermore, there have been no studies comparing among oral, sublingual, and vaginal misoprostol, no medication (control) in these women. The objective of this study is to compare the efficacy and safety of oral, sublingual, vaginal, and no misoprostol prior to operative hysteroscopy in premenopausal women.

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 polyp or other endometrial pathological findings based on the transvaginal ultrasound, were enrolled.

Inclusion criteria

were as follows: women who were of reproductive age (i.e., were premenopausal) and were not pregnant at the time of presentation (i.e., negative for urine pregnancy test or last menstrual period within the last 4 weeks). -

Exclusion criteria

Exclusion criteria

included any evidence of a contraindication to prostaglandins (history of severe asthma, glaucoma, preexisting severe cardiac disease, or renal failure), or allergy to prostaglandins, any sign of genital infection, presence of significant uterovaginal prolapse that could affect administration of vaginal tablets, history of cervical surgery, presence of space occupying lesions in endocervical canal, and treatment of GnRH agonist.

Treatment and study plan

Oral misoprostol

Drug

Patients were randomly allocated at the outpatient department into 4 groups with a ratio of 1:1:1:1: the oral, sublingual, vaginal, and no misoprostol group received all 400 μg of misoprostol (two tablets of Cytotec; 200 μg). All misoprostol tablets were identical and patients were blinded to group allocation

Other names: two tablets of Cytotec (200 μg)

Sublingual misoprostol

Drug

Patients were randomly allocated at the outpatient department into 4 groups with a ratio of 1:1:1:1: the oral, sublingual, vaginal, and no misoprostol group received all 400 μg of misoprostol (two tablets of Cytotec; 200 μg). All misoprostol tablets were identical and patients were blinded to group allocation

Other names: two tablets of Cytotec (200 μg)

Vaginal Misoprostol

Drug

Patients were randomly allocated at the outpatient department into 4 groups with a ratio of 1:1:1:1: the oral, sublingual, vaginal, and no misoprostol group received all 400 μg of misoprostol (two tablets of Cytotec; 200 μg). All misoprostol tablets were identical and patients were blinded to group allocation

Other names: two tablets of Cytotec (200 μg)

Control

Drug

The control group was not given any cervical priming agents or placebo.

Primary outcomes

  1. the preoperative cervical width

    Time frame: just before the operation (From finish of anesthesic induction to introduction of a rigid resectoscope with 10-mm outer sheath diameter in uterine cavity)

    The primary outcome measure was the preoperative cervical width at the time of operation. The cervical width was assessed by performing cervical dilation, starting with a number 10 Hegar dilator and subsequently inserting smaller Hegar dilators until dilator could pass through the internal os without resistance. The largest one that could be passed was recorded as the initial cervical width.

Secondary outcomes

  1. misoprostol-associated side effects

    Time frame: before the procedures

Sponsors and collaborators

Lead sponsor

CHA University

Other

Registry information

Official study title

A Randomized Comparison of Oral, Sublingual and Vaginal Misoprostol Administration in Premenopausal Women Before Operative Hysteroscopy

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 6, 2013
Registry last updated
Dec 25, 2014

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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