Vaginal Dinoprostone Versus Vaginal Misoprostol Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT04044079

Collaborator

(none)

150

Enrollment

Location

Arms

5.7

Actual Duration (Months)

26.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare the effectiveness of vaginal dinoprostone and vaginal misoprostol with placebo in minimizing the pain experienced by postmenopausal patients during diagnostic ofﬁce hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopist.

Condition or Disease	Intervention/Treatment	Phase
Office Hysteroscopy	Drug: Dinoprostone Drug: Misoprostol Drug: Placebo	Phase 4

Detailed Description

hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as polyps, ﬁbroids, septa, and adhesions, and in the presence of abnormal bleeding and during the removal of an intrauterine device or foreign body. Cervical ripening is made possible by the use of medication through different routes. The most commonly used agent is misoprostol, a synthetic prostaglandin E1 (PGE1) analog that is frequently administered in off-label use in obstetrics and gynecology for medical abortion, labor induction, endometrial biopsy, dilatation and curettage, intrauterine device insertion, myomectomy, postpartum hemorrhage, and cervical ripening. In contrast, dinoprostone, a natural PGE2, is mostly used in obstetrics for cervical ripening and the stimulation of uterine contractions to induce labor.

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

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

Primary Purpose:

Treatment

Official Title:

Vaginal Dinoprostone Versus Vaginal Misoprostol Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients: a Randomized Controlled Trial

Actual Study Start Date :

Aug 20, 2019

Actual Primary Completion Date :

Jan 10, 2020

Actual Study Completion Date :

Feb 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: dinoprostone 1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.	Drug: Dinoprostone 1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.
Active Comparator: misoprostol Misoprostol (200µg) will be administered vaginally 12 hours before office hysteroscopy.	Drug: Misoprostol Misoprostol (200µg) will be administered vaginally 12 hours before office hysteroscopy.
Placebo Comparator: placebo one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.	Drug: Placebo one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.

Arm

Intervention/Treatment

Experimental: dinoprostone

1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.

Drug: Dinoprostone

1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.

Active Comparator: misoprostol

Misoprostol (200µg) will be administered vaginally 12 hours before office hysteroscopy.

Drug: Misoprostol

Misoprostol (200µg) will be administered vaginally 12 hours before office hysteroscopy.

Placebo Comparator: placebo

one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.

Drug: Placebo

one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.

Outcome Measures

Primary Outcome Measures

Intensity of pain [an expected average of 10 minutes]
Pain intensity will be assessed by visual analogue scale during the procedure.visual analogue scale ranging from 0 to 10

Secondary Outcome Measures

Intensity of pain [30 minutes after the procedure]
Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10
Operative time [an expected average 10 minutes]
From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Menopausal patients with an indication for ofﬁce hysteroscopy (postmenopausal bleeding or abnormal ultrasound ﬁndings)

Exclusion Criteria:

Nulliparous patients
patients with cervical pathology
retroverted uterus (detected by transvaginal ultrasound)
previous cervical surgery
patients with severe vaginal bleeding
allergy or contraindications to dinoprostone or misoprostol therapy (asthma, liver, kidney, or heart disease).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmed Samy	Giza		Egypt	11231

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:

NCT04044079

Other Study ID Numbers:

dinoprostone misoprostol

First Posted:

Aug 2, 2019

Last Update Posted:

Sep 1, 2020

Last Verified:

Aug 1, 2020

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

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

Additional relevant MeSH terms:

Misoprostol

Dinoprostone

Study Results

No Results Posted as of Sep 1, 2020