Pharmacological Preparation of the Cervix for Hysteroscopy

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

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.

Study Overview

• Status: Completed
• Conditions: Uterine Bleeding; Endometrium; Senility; Uterine Polyp
• Intervention / Treatment: Drug: estradiol; Drug: Hyaluronic acid

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 Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Kraków, Poland, 31-501
    • Jagiellonian University Medical College, Department of Gynecology and Obstetrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1 (estradiol); estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure	Drug: estradiol; estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure
Active Comparator: 2 (hyaluronic acid); hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure	Drug: Hyaluronic acid; hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure
No Intervention: 3 (control); no preparation of the cervix - arm without medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensification of pain during and after the procedure	Intensity of pain in Numeric Rating Scale (NRS: 0-10)	up to 6 months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervical passage time	Cervical penetration time (minutes) from visualization of the external cervical os to reaching the uterine cavity	up to 6 months
Occurrence of a vasovagal reaction	the occurrence of a vasovagal reaction (fall in blood pressure, bradycardia, syncope)	up to 6 months
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

Collaborators and Investigators

• Sponsor: Jagiellonian University
• Investigators: Study Chair: Robert Jach, Prof., Jagiellonian University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: March 11, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Uterine Hemorrhage; Physiological Effects of Drugs; Immunologic Factors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protective Agents; Estrogens; Adjuvants, Immunologic; Viscosupplements; Estradiol; Hyaluronic Acid
• Other Study ID Numbers: 1072.6120.128.2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No