Optimal Timing of Dinoprostone Administration Prior to Office Hysteroscopy

Phase 3

Completed

• Conditions: Dinoprostone Timing
• Interventions: Drug: short interval dinoprostone; Drug: long interval dinoprostone

• Registration Number: NCT04085757
• Lead Sponsor: Cairo University

Brief Summary

The aim of this study is to determine whether dinoprostone administered 10 hours before office hysteroscopy can relieve pain more effectively compared with dinoprostone administered 3 hours before office hysteroscopy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-07
• Study First Submitted QC: 2019-09-07
• Study First Posted: 2019-09-11
• Study Start: 2019-09-15
• Primary Completion: 2019-12-15
• Study Completion: 2020-01-01
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-05
• Last Update Posted: 2021-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

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, allergy to dinoprostone

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
short interval dinoprostone	short interval dinoprostone	A small envelope including two labeled plastic bags (A\& B) (each bag containing either 1 dinoprostone tablets(3 mg) or 1 identically appearing placebo tablet) will be packaged in sequentially numbered sealed envelopes. In short interval dinoprostone group, bag (A) contains placebo tablet and bag (B) contains dinoprostone tablet. 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.
long interval dinoprostone	long interval dinoprostone	A small envelope including two labeled plastic bags (A \& B) (each bag containing either 1 dinoprostone tablet(3mg) or 1 identically appearing placebo tablet) will be packaged in sequentially numbered sealed envelopes. In long interval dinoprostone group, bag (A) contains dinoprostone tablet and bag (B) contains placebo tablet. 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	intraoperative	Intensity of pain by visual analog scale from 0(no pain) to 100 mm(worst pain imaginable)

Trial Locations

Locations (2)

Tertiary referral hospital; 🇪🇬 Giza, Egypt

faculty of medicine Cairo university; 🇪🇬 Giza, Egypt