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
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