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

Phase 3
18 Years
55 Years
Open (Enrolling)
Endometrial Disorder

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Trial Information

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

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.

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.

Type of Study:


Study Design:

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

Outcome Measure:

the preoperative cervical width

Outcome Description:

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.

Outcome 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)

Safety Issue:


Principal Investigator

Taejong Song, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Obstetrics and Gynecology, CHA Gangnam Medical Center, CHA University, Seoul, Korea


Korea: Food and Drug Administration

Study ID:




Start Date:

March 2013

Completion Date:

July 2014

Related Keywords:

  • Endometrial Disorder
  • hysteroscopy
  • misoprostol
  • Endometriosis
  • Endometritis
  • Adenoma