Optimal Timing of Dinoprostone Administration Prior to Office Hysteroscopy

Cairo University180 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

180

Conditions

Dinoprostone Timing

Interventions

long interval dinoprostoneDRUG

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.

short interval dinoprostoneDRUG

A small envelope including two labeled plastic bags (A\& B) (each bag containing either 1 dinoprostone tablet(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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (2)

faculty of medicine Cairo university

Giza, Egypt

Tertiary referral hospital

Giza, Egypt

Outcomes

Primary Outcomes

Intensity of pain

Intensity of pain by visual analog scale from 0(no pain) to 100 mm(worst pain imaginable)

Time frame: intraoperative

Data from ClinicalTrials.gov

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