Vaginal Dinoprostone Versus Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04500496

Enrollment

200

Registered

2020-08-05

Start date

2020-09-01

Completion date

2022-01-30

Last updated

2021-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopausal Bleeding

Brief 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.

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.

Interventions

DRUGINH

3 tablet of INH inserted by the patient 12 hours before the scheduled office hysteroscopy

DRUGdinoprostone

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Masking description

open label randomized controlled study

Intervention model description

open label randomized controlled study

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 60 Years

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 INH therapy

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Egypt

Contacts

Primary Contacthany f Sallam, md

hany.farouk@aswu.edu.eg+20102435461

Backup Contactnahla w Shady, md

hanygyne@yahoo.com+201022336052

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026