Trial record 6 of 12 for:    Open Studies | "Pelvic Inflammatory Disease"

Misoprostol Administration Before Operative Hysteroscopy

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by CHA University
Sponsor:
Information provided by (Responsible Party):
Taejong Song, CHA University
ClinicalTrials.gov Identifier:
NCT01805115
First received: March 4, 2013
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

The objective of this study is to compare the efficacy of oral, sublingual, vaginal, and no misoprostol prior to operative hysteroscopy in premenopausal women.


Condition Intervention Phase
Endometrial Disorder
Drug: Oral misoprostol
Drug: Sublingual misoprostol
Drug: Vaginal misoprostol
Drug: Control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Oral, Sublingual and Vaginal Misoprostol Administration in Premenopausal Women Before Operative Hysteroscopy

Resource links provided by NLM:


Further study details as provided by CHA University:

Primary Outcome Measures:
  • the preoperative cervical width [ 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) ] [ Designated as safety issue: No ]
    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:
  • misoprostol-associated side effects [ Time Frame: before the procedures ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: March 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral misoprostol
The oral group (misoprostol 400 ug) self-administered the medications orally 8-10 h before surgery.
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
Other Name: two tablets of Cytotec (200 μg)
Experimental: Sublingual misoprostol
The sublingual group (misoprostol 400 ug) self-administered the medications sublingually 8-10 h before surgery.
Drug: 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
Other Name: two tablets of Cytotec (200 μg)
Experimental: Vaginal misoprostol
The vaginal group (misoprostol 400 ug) self-administered the medications vaginally 8-10 h before surgery.
Drug: 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
Other Name: two tablets of Cytotec (200 μg)
Experimental: Control
The no-misoprostol group did not administer the medication of misoprostol before the procedure
Drug: Control
The control group was not given any cervical priming agents or placebo.

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01805115

Contacts
Contact: Taejong Song, MD +82-2-3468-3032 taejong.song@gmail.com

Locations
Korea, Republic of
CHA Gangnam Medical Center Recruiting
Seoul, Korea, Republic of, 135-081
Contact: Taejong Song, MD    +82-2-3468-3032    taejong.song@gmail.com   
Principal Investigator: Taejong Song, MD         
Sponsors and Collaborators
CHA University
Investigators
Principal Investigator: Taejong Song, MD Department of Obstetrics and Gynecology, CHA Gangnam Medical Center, CHA University, Seoul, Korea
  More Information

No publications provided

Responsible Party: Taejong Song, Professor, CHA University
ClinicalTrials.gov Identifier: NCT01805115     History of Changes
Other Study ID Numbers: KNC13-005
Study First Received: March 4, 2013
Last Updated: November 21, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by CHA University:
hysteroscopy
misoprostol

Additional relevant MeSH terms:
Pelvic Inflammatory Disease
Endometriosis
Endometritis
Genital Diseases, Female
Adnexal Diseases
Uterine Diseases
Misoprostol
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on July 22, 2014