Pharmacological Preparation of the Cervix for Hysteroscopy

Uterine Bleeding Clinical Trial

Official title:

Estriol and Hyaluronic Acid in Cervical Preparation for Mini-hysteroscopy in Peri- and Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05783479
• Other study ID #: 1072.6120.128.2021
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: March 2023
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: January 31, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Uterine Bleeding
• Uterine Hemorrhage

Intervention

Drug:
• estradiol
estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure
• Hyaluronic acid
hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure

Locations

Country	Name	City	State
Poland	Jagiellonian University Medical College, Department of Gynecology and Obstetrics	Kraków

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensification of pain during and after the procedure	Intensity of pain in Numeric Rating Scale (NRS: 0-10)	up to 6 months
Primary	The need of cervical dilation	The need for cervical dilation (yes/no) to penetrate the cervix and enter the uterine cavity	up to 6 months
Secondary	Cervical passage time	Cervical penetration time (minutes) from visualization of the external cervical os to reaching the uterine cavity	up to 6 months
Secondary	Occurrence of a vasovagal reaction	the occurrence of a vasovagal reaction (fall in blood pressure, bradycardia, syncope)	up to 6 months
Secondary	Occurrence of severe urogenital atrophy (paleness and thinning of the vaginal epithelium, petechiae and shallow ulcers, bleeding and contact)	Clinical evaluation of the occurrence of symptoms of urogenital atrophy	up to 6 months