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NCT03457350 Clinical Trial

Office Hysteroscopy Versus Cervical Probing for Cervical Stenosis

Hysteroscopy Clinical Trial

Official title:
Small-caliber Office Hysteroscopy Versus Blind Cervical Probing for Tight Primary Cervical Stenosis in Nulliparous Women: a Preliminary Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03457350
Other study ID # hysteroscopy versus probing
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2012
Est. completion date February 2018

Study information
Verified date April 2022
Source Woman's Health University Hospital, Egypt
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to estimate if performing a small caliber office hysteroscopic cervical negotiation would succeed to bypass tight markedly stenotic cervix in comparison to blind cervical probing done under general anesthesia. Moreover, the investigators test the impact of drawing a detailed diagram after this procedure on the success of ET in participants with failed mock or actual trials of embryo transfer (ET).

Description:

It comprises 122 nulliprous women with failed cervical sounding on vaginal examination in the office. Participants were divided into 2 groups. Group A comprised 64 cases subjected to small-caliber office hysteroscopic cervical negotiation while 58 cases were subjected to cervical probing under general anesthesia. Main outcome measures included success to bypass primary cervical stenosis and complication rate

Recruitment information / eligibility
Status Completed
Enrollment 128
Est. completion date February 2018
Est. primary completion date February 2018
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 45 Years
Eligibility Inclusion Criteria: - Nulliprous women. - Failed cervical sounding on vaginal examination in the office. Exclusion Criteria: - Previous operation on the cervix. - Use of any medication to prime the cervix (primary). - Multiparity: weather delivered vaginally or by cesarean sectrion

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• cervical negotiation
trial to bypass severe cervical stenosis

Locations
Country Name City State
Egypt Woman's Health University Hospital Assiut

Sponsors (1)
Lead Sponsor Collaborator
Woman's Health University Hospital, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary How many cases of access to the endometrial cavity overcoming cervical stenosis 20 minutes
Secondary complication rate how many cases with perforation or false passage 20 minutes
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