Vaginal Dinoprostone Versus Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy

NCT04500496 — Not applicable, Unknown, 200 participants, Aswan University Hospital

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

Registry	NCT04500496
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	200 (Estimated)
Sponsor	Aswan University Hospital (Other)
Conditions	Postmenopausal Bleeding
Interventions	INH, dinoprostone (Drug)
Dates	start 2020-09-01, primary completion 2021-12-30 (estimated), completion 2022-01-30 (estimated), first posted 2020-08-05, last updated 2021-09-29
Locations	1 site in Egypt

-Summary

To compare the effectiveness of vaginal dinoprostone and vaginal Isonicotinic acid hydrazide 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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
INH	Experimental	Drug: INH	3 tablet of INH 900 mg inserted by the patient 12 hours before the scheduled office hysteroscopy.
dinoprostone	Active comparator	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.

INH (Drug), also known as Isonicotinic acid hydrazide: 3 tablet of INH inserted by the patient 12 hours before the scheduled office hysteroscopy
dinoprostone (Drug), also known as prostin: 1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.

+Outcome measures

Primary outcomes

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

Secondary outcomes

Operative time [15 minutes]: From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination
Pain intensity will be assessed by visual analogue scale [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

+Eligibility

Sex: Female, ages: 45 Years to 60 Years

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 INH therapy

+Locations (1)

Facility	City	Country	Status
Aswan University Hospital	Aswān	Egypt	Recruiting

+Investigators

nahla w Shady, md, Study chair, Aswan universirty

My Notes

Public

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