Clinical trial NCT01805115: Misoprostol Administration Before Operative Hysteroscopy
Official title: A Randomized Comparison of Oral, Sublingual and Vaginal Misoprostol Administration in Premenopausal Women Before Operative Hysteroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Endometrial Disorder
Keywords: hysteroscopy
misoprostol
Lead sponsor: CHA University
Sponsor class: OTHER
First posted: 2013-03-06
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 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.

Primary outcomes:
measure: the preoperative cervical width
timeFrame: just before the operation (From finish of anesthesic induction to introduction of a rigid resectoscope with 10-mm outer sheath diameter in uterine cavity)
Secondary outcomes:
measure: misoprostol-associated side effects
timeFrame: before the procedures
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: CHA Gangnam Medical Center
Study officials:
affiliation: Department of Obstetrics and Gynecology, CHA Gangnam Medical Center, CHA University, Seoul, Korea
name: Taejong Song, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Song T, Kim MK, Kim ML, Jung YW, Yoon BS, Seong SJ. Effectiveness of different routes of misoprostol administration before operative hysteroscopy: a randomized, controlled trial. Fertil Steril. 2014 Aug;102(2):519-24. doi: 10.1016/j.fertnstert.2014.04.040. Epub 2014 May 23.