Pharmacological Preparation of the Cervix for Hysteroscopy

Not Applicable

Completed

• Conditions: Endometrium; Senility; Uterine Bleeding; Uterine Polyp
• Interventions: Drug: estradiol; Drug: Hyaluronic acid

• Registration Number: NCT05783479
• Lead Sponsor: Jagiellonian University

Brief Summary

Pain accompanying office hysteroscopy is the most common reason for its discontinuation. Urogenital atrophy may cause technical difficulties in passage through the cervical canal, further increasing the pain. The aim was to evaluate the effectiveness of vaginal estradiol and hyaluronic acid to facilitate diagnostic hysteroscopy in peri- and postmenopausal women.

Detailed Description

A prospective cohort tertiary-center study includes women over 45 years of age subjected to office hysteroscopy in 2021-2022. Women who consent are assigned to three study arms: i) estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure, ii) hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure, iii) no treatment (control). The following endpoints are compared: need for cervical dilation, incidence of severe urogenital atrophy and vaso-vagal reaction, time of cervical passage, cervical canal diameter, pain during and after the procedure in the Numeric Rating Scale (NRS).

Study Timeline

• Study Start: 2022-06-01
• Primary Completion: 2022-12-30
• Study Completion: 2023-01-31
• Status Verified: 2023-03
• Study First Submitted: 2023-03-11
• Study First Submitted QC: 2023-03-23
• Last Update Submitted: 2023-03-23
• Study First Posted: 2023-03-24
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 96

Inclusion Criteria

• age 45-90 years
• uterine cavity focal lesion, abnormal uterine bleeding

Exclusion Criteria

• drug allergy
• no consent to the procedure or participation in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 (estradiol)	estradiol	estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure
2 (hyaluronic acid)	Hyaluronic acid	hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure

Primary Outcome Measures

Name	Time	Method
The need of cervical dilation	up to 6 months	The need for cervical dilation (yes/no) to penetrate the cervix and enter the uterine cavity
Intensification of pain during and after the procedure	up to 6 months	Intensity of pain in Numeric Rating Scale (NRS: 0-10)

Secondary Outcome Measures

Name	Time	Method
Cervical passage time	up to 6 months	Cervical penetration time (minutes) from visualization of the external cervical os to reaching the uterine cavity
Occurrence of severe urogenital atrophy (paleness and thinning of the vaginal epithelium, petechiae and shallow ulcers, bleeding and contact)	up to 6 months	Clinical evaluation of the occurrence of symptoms of urogenital atrophy
Occurrence of a vasovagal reaction	up to 6 months	the occurrence of a vasovagal reaction (fall in blood pressure, bradycardia, syncope)

Trial Locations

Locations (1)

Jagiellonian University Medical College, Department of Gynecology and Obstetrics; 🇵🇱 Kraków, Poland