Pharmacological Preparation of the Cervix for Hysteroscopy

NCT ID: NCT05783479

Last Updated: 2023-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-01-31

Brief Summary

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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

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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).

Conditions

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Uterine Polyp Uterine Bleeding Endometrium; Senility

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Comparison of endpoints in 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).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1 (estradiol)

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

Group Type ACTIVE_COMPARATOR

estradiol

Intervention Type DRUG

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

2 (hyaluronic acid)

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

Group Type ACTIVE_COMPARATOR

Hyaluronic acid

Intervention Type DRUG

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

3 (control)

no preparation of the cervix - arm without medication

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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estradiol

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

Intervention Type DRUG

Hyaluronic acid

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Jagiellonian University

OTHER

Sponsor Role lead

Responsible Party

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Iwona Magdalena Gawron

Ph.D., Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Jach, Prof.

Role: STUDY_CHAIR

Jagiellonian University

Locations

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Jagiellonian University Medical College, Department of Gynecology and Obstetrics

Krakow, , Poland

Site Status

Countries

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Poland

Other Identifiers

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1072.6120.128.2021

Identifier Type: -

Identifier Source: org_study_id

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