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Misoprostol Administration Before Operative Hysteroscopy

NCT ID: NCT01805115

Last Updated: 2014-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-02-28

Brief Summary

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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

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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.

Conditions

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Endometrial Disorder

Keywords

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hysteroscopy misoprostol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Oral misoprostol

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

Group Type EXPERIMENTAL

Oral misoprostol

Intervention Type 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

Sublingual misoprostol

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

Group Type EXPERIMENTAL

Sublingual misoprostol

Intervention Type 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

Vaginal misoprostol

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

Group Type EXPERIMENTAL

Vaginal misoprostol

Intervention Type 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

Control

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

Group Type EXPERIMENTAL

Control

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Control

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

Intervention Type DRUG

Other Intervention Names

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two tablets of Cytotec (200 μg) two tablets of Cytotec (200 μg) two tablets of Cytotec (200 μg)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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CHA University

OTHER

Sponsor Role lead

Responsible Party

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Taejong Song

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Taejong Song, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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CHA Gangnam Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 24856464 (View on PubMed)

Other Identifiers

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KNC13-005

Identifier Type: -

Identifier Source: org_study_id