Optimum Misoprostol Dose Prior to Office Hysteroscopy

NCT ID: NCT01612065

Last Updated: 2013-04-11

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

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-04-30

Brief Summary

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Misoprostol is an effective agent for cervical priming before office hysteroscopy, vaginal route is the best, optimum dose not yet known.

Detailed Description

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The investigators will compare between 2 different doses of vaginal misoprostol, group (1) 200 ug, group (2) 400 ug, 3hours prior to office hysteroscopy , Infertile patient, patients with abnormal bleeding and patient with recurrent abortion Outcome measure: pain score, easiness of the procedure, procedure time, complications

Conditions

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Infertility Abnormal Uterine and Vaginal Bleeding, Unspecified Recurrent Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Misoprostol vaginally, 200 ug

200 ug misoprostol in the posterior vaginal fornix

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

200 ug

Misoprostol vaginally, 400ug

Misoprostol in the posterior vaginal fornix

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

Misoprostol vaginally, 400 ug

Interventions

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Misoprostol

200 ug

Intervention Type DRUG

Misoprostol

Misoprostol vaginally, 400 ug

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female patient pre- or postmenopausal undergo office hysteroscopy.
* Age: from 20 to 60.
* BMI between 18 and 30.

Exclusion Criteria

* PID or
* Heavy uterine bleeding
* Cervical malignancy.
* Symptoms suggestive of endometriosis .
* Any cervical abnormality such as pinhole cervix that would obviate passage of a catheter through the cervix.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Waleed El-khayat

Assistant professor of obstetrics and gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Waleed El-khayat, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Kasr alainy hospital, faculty of medicine , Cairo university

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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2752012

Identifier Type: -

Identifier Source: org_study_id

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