Misoprostol Administration Before Operative Hysteroscopy

Endometrial Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01805115
• Other study ID #: KNC13-005
• Status: Completed
• Phase: Phase 3
• First received: March 4, 2013
• Last updated: December 24, 2014
• Start date: March 2013
• Est. completion date: February 2014

Study information

• Verified date: December 2014
• Source: CHA University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Endometrial Disorder

Intervention

Drug:
• Oral misoprostol
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
• Sublingual misoprostol
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
• Vaginal misoprostol
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
• Control
The control group was not given any cervical priming agents or placebo.

Locations

Country	Name	City	State
Korea, Republic of	CHA Gangnam Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
CHA University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	misoprostol-associated side effects		before the procedures	Yes