Optimal Timing of Dinoprostone Administration Prior to Office Hysteroscopy

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT04085757

Collaborator

(none)

180

Enrollment

Locations

Arms

3.5

Actual Duration (Months)

Patients Per Site

25.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dinoprostone Timing	Drug: long interval dinoprostone Drug: short interval dinoprostone	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Determining the Optimal Time Interval Between Vaginal Dinoprostone Administration and Diagnostic Office Hysteroscopy in Nulliparous Women: A Randomized Double-Blind Trial

Actual Study Start Date :

Sep 15, 2019

Actual Primary Completion Date :

Dec 15, 2019

Actual Study Completion Date :

Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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.
Active Comparator: 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.	Drug: short interval dinoprostone 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.

Arm

Intervention/Treatment

Experimental: 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.

Drug: long interval dinoprostone

Active Comparator: 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.

Drug: short interval dinoprostone

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	faculty of medicine Cairo university	Giza		Egypt	11231
2	Tertiary referral hospital	Giza		Egypt

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: AHMED SAMY, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Samy aly ashour, assistant professor, Cairo University

ClinicalTrials.gov Identifier:

NCT04085757

Other Study ID Numbers:

dinoprostone timing

First Posted:

Sep 11, 2019

Last Update Posted:

May 7, 2021

Last Verified:

May 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dinoprostone

Study Results

No Results Posted as of May 7, 2021