Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03683914
• Collaborator: (none)
• Enrollment: 102
• Location: 1
• Arms: 2
• Actual Duration (Months): 5
• Patients Per Site Per Month: 20.6

Study Details

Study Description

Brief Summary

To compare the effectiveness of vaginal dinoprostone with placebo in minimising 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 3Mg Vaginal Tablet; Drug: placebo vaginal tablet	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) analogue that is frequently administered in off-label use in obstetrics and gynaecology for medical abortion, labor induction, endometrial biopsy, dilatation and curettage, intrauterine device insertion, myomectomy, postpartum haemorrhage, 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: 102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients: A Randomized Double-Blind Placebo-Controlled Trial
• Actual Study Start Date: Sep 30, 2018
• Actual Primary Completion Date: Jan 30, 2019
• Actual Study Completion Date: Feb 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: dinoprostone arm 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 3Mg Vaginal Tablet; 1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office diagnostic hysteroscopy.
Placebo Comparator: placebo one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.	Drug: placebo vaginal tablet; 1 vaginal tablet of placebo inserted by the patient 12 hours before the scheduled office diagnostic hysteroscopy.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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: No

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 therapy (asthma, liver, kidney, or heart disease).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine Cairo University	Cairo		Egypt	11231

Sponsors and Collaborators

• Cairo University

Investigators

• Principal Investigator: AHMED SAMY, MD, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Samy aly ashour, lecturer in obstetrics and gynecology, Cairo University
• ClinicalTrials.gov Identifier: NCT03683914
• Other Study ID Numbers: vaginal dinoprostone
• First Posted: Sep 25, 2018
• Last Update Posted: Mar 26, 2019
• Last Verified: Mar 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dinoprostone

Study Results

No Results Posted as of Mar 26, 2019