Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients

Hysteroscopy Clinical Trial

Official title:

Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients:a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04042974
• Other study ID #: dinoprostone hysteroscopy
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 10, 2019
• Est. completion date: November 20, 2019

Study information

• Verified date: July 2019
• Source: Cairo University
• Contact: AHMED SAMY, MD
• Phone: +201100681167
• Email: ahmedsamy8233[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 20, 2019
• Est. primary completion date: November 10, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 40 Years

Eligibility

Inclusion Criteria:

• nulliparous women with primary infertility requiring a diagnostic hysteroscopy as a part of an infertility diagnosis workup

Exclusion Criteria:

• • women with suspected pregnancy

• heavy vaginal bleeding

• recent pelvic infection

• those known to have hypersensitivity or contraindication to dinoprostone

• those who received analgesics prior to OH

• a concomitant neurologic disease that could affect the correct evaluation of pain

Related Conditions & MeSH terms

• Hysteroscopy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of pain	Pain intensity will be assessed by visual analogue scale during the procedure.visual analogue scale ranging from 0 to 10	an expected average of 10 minutes
Secondary	Intensity of pain	Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10	30 minutes after the procedure
Secondary	Operative time	From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination	an expected average 10 minutes