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Misoprostol Administration Before Operative Hysteroscopy

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ClinicalTrials.gov Identifier: NCT01805115
Recruitment Status : Completed
First Posted : March 6, 2013
Last Update Posted : December 25, 2014
Sponsor:
Information provided by (Responsible Party):
Taejong Song, 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.

Condition or disease Intervention/treatment Phase
Endometrial Disorder Drug: Oral misoprostol Drug: Sublingual misoprostol Drug: Vaginal misoprostol Drug: Control Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Oral, Sublingual and Vaginal Misoprostol Administration in Premenopausal Women Before Operative Hysteroscopy
Study Start Date : March 2013
Primary Completion Date : January 2014
Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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) ]
    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 :
  1. misoprostol-associated side effects [ Time Frame: before the procedures ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01805115


Locations
Korea, Republic of
CHA Gangnam Medical Center
Seoul, Korea, Republic of, 135-081
Sponsors and Collaborators
CHA University
Investigators
Principal Investigator: Taejong Song, MD Department of Obstetrics and Gynecology, CHA Gangnam Medical Center, CHA University, Seoul, Korea

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Taejong Song, Professor, CHA University
ClinicalTrials.gov Identifier: NCT01805115     History of Changes
Other Study ID Numbers: KNC13-005
First Posted: March 6, 2013    Key Record Dates
Last Update Posted: December 25, 2014
Last Verified: December 2014

Keywords provided by Taejong Song, CHA University:
hysteroscopy
misoprostol

Additional relevant MeSH terms:
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics