Optimal Timing of Misoprostol Administration Prior to Office Hysteroscopy

Phase 2

Completed

• Conditions: Pain
• Interventions: Drug: Long interval misoprostol; Drug: Short interval misoprostol

• Registration Number: NCT02316301
• Lead Sponsor: Cairo University

Brief Summary

The aim of this study was to determine whether misoprostol administered 12 hours before office hysteroscopy can relieve pain more effectively compared with misoprostol administered 3 hours before office hysteroscopy.

Detailed Description

The interval between misoprostol administration and office hysteroscopy may have an influence on its effectiveness in pain reduction. There are limited data on the optimal interval from administration of misoprostol and office hysteroscopy. In previous studies, time interval from administration of misoprostol and office hysteroscopy ranged between 2 hours and 24 hours.

Till now no studies have yet investigated the optimal timing of misoprostol administration prior to office hysteroscopy or operative hysteroscopy. The aim of this study was to determine whether misoprostol administered 12 hours before office hysteroscopy can relieve pain more effectively compared with misoprostol administered 3 hours before office hysteroscopy

Study Timeline

• Study First Submitted: 2014-12-10
• Study First Submitted QC: 2014-12-11
• Study First Posted: 2014-12-12
• Study Start: 2015-01
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-26
• Last Update Posted: 2016-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• Nulliparous patients who have an indication for office hysteroscopy

Exclusion Criteria

• Parous patients, menopausal patients and patients with cervical pathology, and previous cervical surgery will be excluded from the study. Moreover, patients with severe vaginal bleeding, acute pelvic inflammatory disease, glaucoma, allergy to misoprostol, cardiac, liver or kidney diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Long interval misoprostol	Long interval misoprostol	A small envelope including two labeled plastic bags (A \& B) (each bag containing either 2 misoprostol tablets(400µg) or 2 identically appearing placebo tablets) will be packaged in sequentially numbered sealed envelopes. In long interval misoprostol group, bag (A) contains misoprostol tablets and bag (B) contains placebo tablets. After signing the informed consent, the sequentially numbered sealed envelopes will be opened (according to the sequence of attendance of the patient) by the study nurse. Tablets in bag (A) will be inserted 12 hours before office hysteroscopy and tablets in bag (B) will be inserted 3 hours before office hysteroscopy.
Short interval misoprostol	Short interval misoprostol	A small envelope including two labeled plastic bags (A\& B) (each bag containing either 2 misoprostol tablets(400µg) or 2 identically appearing placebo tablets) will be packaged in sequentially numbered sealed envelopes. In short interval misoprostol group, bag (A) contains placebo tablets and bag (B) contains misoprostol tablets. After signing the informed consent, the sequentially numbered sealed envelopes will be opened (according to the sequence of attendance of the patient) by the study nurse. Tablets in bag (A) will be inserted 12 hours before office hysteroscopy and tablets in bag (B) will be inserted 3 hours before office hysteroscopy.

Primary Outcome Measures

Name	Time	Method
Intensity of pain	up to 30 minutes

Secondary Outcome Measures

Name	Time	Method
Duration of procedure	intraoperative

Trial Locations

Locations (1)

Obstetrics and Gynecology Department,Cairo university; 🇪🇬 Cairo, Egypt