Misoprostol Administration Before Operative Hysteroscopy

Phase 3

Completed

• Conditions: Endometrial Disorder
• Interventions: Drug: Sublingual misoprostol; Drug: Oral misoprostol; Drug: Control; Drug: Vaginal misoprostol

• Registration Number: NCT01805115
• Lead Sponsor: CHA University

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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-04
• Study First Submitted QC: 2013-03-04
• Study First Posted: 2013-03-06
• Primary Completion: 2014-01
• Study Completion: 2014-02
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-24
• Last Update Posted: 2014-12-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sublingual misoprostol	Sublingual misoprostol	The sublingual group (misoprostol 400 ug) self-administered the medications sublingually 8-10 h before surgery.
Oral misoprostol	Oral misoprostol	The oral group (misoprostol 400 ug) self-administered the medications orally 8-10 h before surgery.
Control	Control	The no-misoprostol group did not administer the medication of misoprostol before the procedure
Vaginal misoprostol	Vaginal misoprostol	The vaginal group (misoprostol 400 ug) self-administered the medications vaginally 8-10 h before surgery.

Primary Outcome Measures

Name	Time	Method
the preoperative cervical width	just before the operation (From finish of anesthesic induction to introduction of a rigid resectoscope with 10-mm outer sheath diameter in uterine cavity)	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.

Secondary Outcome Measures

Name	Time	Method
misoprostol-associated side effects	before the procedures

Trial Locations

Locations (1)

CHA Gangnam Medical Center; 🇰🇷 Seoul, Korea, Republic of