Pharmacological Preparation of the Cervix for Hysteroscopy

Jagiellonian University

Status: Completed

Conditions: Uterine Bleeding; Endometrium; Senility; Uterine Polyp

Treatments: Drug: estradiol; Drug: Hyaluronic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT05783479

1072.6120.128.2021

Details and patient eligibility

About

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.

Full 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).

Enrollment: 96 patients

Sex: Female

Ages: 45 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 3 patient groups

1 (estradiol)

Active Comparator group

Description:

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

Treatment:

Drug: estradiol

2 (hyaluronic acid)

Active Comparator group

Description:

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

Treatment:

Drug: Hyaluronic acid

3 (control)

No Intervention group

Description:

no preparation of the cervix - arm without medication