Optimum Misoprostol Dose Prior to Office Hysteroscopy

Phase 3

Completed

• Conditions: Infertility; Abnormal Uterine and Vaginal Bleeding, Unspecified; Recurrent Abortion
• Interventions: Drug: Misoprostol

• Registration Number: NCT01612065
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2012-05-28
• Study Start: 2012-06
• Study First Submitted QC: 2012-06-04
• Study First Posted: 2012-06-05
• Primary Completion: 2013-03
• Status Verified: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2013-04-10
• Last Update Posted: 2013-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 132

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Misoprostol vaginally, 200 ug	Misoprostol	200 ug misoprostol in the posterior vaginal fornix
Misoprostol vaginally, 400ug	Misoprostol	Misoprostol in the posterior vaginal fornix

Primary Outcome Measures

Name	Time	Method
Pain score	1year	Pain score by VAS

Secondary Outcome Measures

Name	Time	Method
Easiness	1year	ease of entry of the office hysteroscopy into the cervix recorded on a 5-point Likert scale: very difficult= 1, difficult = 2, fair = 3, easy = 4, and very easy = 5;
Duration of the procedure	1year	Duration of hysteroscopy in seconds

Trial Locations

Locations (1)

Kasr alainy hospital, faculty of medicine , Cairo university; 🇪🇬 Cairo, Egypt