Misoprostol Administration Before Operative Hysteroscopy

NCT01805115 | Completed Phase 3

• 1 other identifier: KNC13-005
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Disorder

Keywords

hysteroscopy; misoprostol

Outcome Measures

Primary Outcomes (1)

• the preoperative cervical width

  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.

  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 (1)

• misoprostol-associated side effects

  before the procedures

Study Arms (4)

Oral misoprostol

EXPERIMENTAL

The oral group (misoprostol 400 ug) self-administered the medications orally 8-10 h before surgery.

Drug: Oral misoprostol

Sublingual misoprostol

EXPERIMENTAL

The sublingual group (misoprostol 400 ug) self-administered the medications sublingually 8-10 h before surgery.

Drug: Sublingual misoprostol

Vaginal misoprostol

EXPERIMENTAL

The vaginal group (misoprostol 400 ug) self-administered the medications vaginally 8-10 h before surgery.

Drug: Vaginal misoprostol

Control

EXPERIMENTAL

The no-misoprostol group did not administer the medication of misoprostol before the procedure

Drug: Control

Interventions

Oral misoprostol DRUG

Patients were randomly allocated at the outpatient department into 4 groups with a ratio of 1:1:1:1: the oral, sublingual, vaginal, and no misoprostol group received all 400 μg of misoprostol (two tablets of Cytotec; 200 μg). All misoprostol tablets were identical and patients were blinded to group allocation

Also known as: two tablets of Cytotec (200 μg)

Oral misoprostol

Sublingual misoprostol DRUG

Patients were randomly allocated at the outpatient department into 4 groups with a ratio of 1:1:1:1: the oral, sublingual, vaginal, and no misoprostol group received all 400 μg of misoprostol (two tablets of Cytotec; 200 μg). All misoprostol tablets were identical and patients were blinded to group allocation

Also known as: two tablets of Cytotec (200 μg)

Sublingual misoprostol

Vaginal misoprostol DRUG

Patients were randomly allocated at the outpatient department into 4 groups with a ratio of 1:1:1:1: the oral, sublingual, vaginal, and no misoprostol group received all 400 μg of misoprostol (two tablets of Cytotec; 200 μg). All misoprostol tablets were identical and patients were blinded to group allocation

Also known as: two tablets of Cytotec (200 μg)

Vaginal misoprostol

Control DRUG

The control group was not given any cervical priming agents or placebo.

Control

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• CHA University: lead

Study Sites (1)

CHA Gangnam Medical Center

Seoul, 135-081, South Korea

Location

Related Publications (1)

• 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.

  PMID: 24856464 DERIVED

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Taejong Song, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 4, 2013
• First Posted: March 6, 2013
• Study Start: March 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2014
• Last Updated: December 25, 2014

Record last verified: 2014-12

Locations

KR (1)