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Completed

NCT Number: NCT05783479

Pharmacological Preparation of the Cervix for Hysteroscopy

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.

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Key information

Conditions

Uterine Polyp Endometrium; Senility Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Bleeding Uterine Diseases Uterine Hemorrhage

Age range

45 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jagiellonian University Medical College, Department of Gynecology and Obstetrics

Krakow, 31-501, Poland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Estradiol

Drug

estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure

Hyaluronic acid

Drug

hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure

Primary outcomes

  1. Intensification of pain during and after the procedure

    Time frame: up to 6 months

    Intensity of pain in Numeric Rating Scale (NRS: 0-10)

  2. The need of cervical dilation

    Time frame: up to 6 months

    The need for cervical dilation (yes/no) to penetrate the cervix and enter the uterine cavity

Secondary outcomes

  1. Cervical passage time

    Time frame: up to 6 months

    Cervical penetration time (minutes) from visualization of the external cervical os to reaching the uterine cavity

  2. Occurrence of a vasovagal reaction

    Time frame: up to 6 months

    the occurrence of a vasovagal reaction (fall in blood pressure, bradycardia, syncope)

  3. Occurrence of severe urogenital atrophy (paleness and thinning of the vaginal epithelium, petechiae and shallow ulcers, bleeding and contact)

    Time frame: up to 6 months

    Clinical evaluation of the occurrence of symptoms of urogenital atrophy

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Mar 24, 2023
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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