Status:

COMPLETED

Misoprostol Administration Before Operative Hysteroscopy

Lead Sponsor:

CHA University

Conditions:

Endometrial Disorder

Eligibility:

FEMALE

18-55 years

Phase:

PHASE3

Brief Summary

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

Detailed Description

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 l...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

March 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2014

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT01805115

Start Date

March 1 2013

End Date

February 1 2014

Last Update

December 25 2014

Active Locations (1)

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CHA Gangnam Medical Center

Seoul, South Korea, 135-081