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Misoprostol Administration Before Operative Hysteroscopy

Information source: CHA University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Endometrial Disorder

Intervention: Oral misoprostol (Drug); Sublingual misoprostol (Drug); Vaginal misoprostol (Drug); Control (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: CHA University

Official(s) and/or principal investigator(s):
Taejong Song, MD, Principal Investigator, Affiliation: Department of Obstetrics and Gynecology, CHA Gangnam Medical Center, CHA University, Seoul, Korea

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: the preoperative cervical width

Secondary outcome: misoprostol-associated side effects

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 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.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Female.

Criteria:

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.

Locations and Contacts

CHA Gangnam Medical Center, Seoul 135-081, Korea, Republic of
Additional Information

Starting date: March 2013
Last updated: December 24, 2014

Page last updated: August 23, 2015

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