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Office Hysteroscopy Versus Cervical Probing for Cervical Stenosis

Primary Purpose

Hysteroscopy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
cervical negotiation
Sponsored by
Woman's Health University Hospital, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hysteroscopy focused on measuring hysteroscopy, cervical stenosis, probing

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Woman's Health University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

office hysteroscopy

blind cervical probing

Arm Description

Office hysteroscopy 30 degrees 2.6 mm telescope with an outer sheath of 3.2 mm (Storz Co., Tutlingen, Germany). Hysteroscopy is performed as usual by proper examination of the vagina and the ectocervix for any abnormality followed by introduction of the hysteroscope into the cervical canal. At this step, the hysteroscopist waits for a while until the distending fluid forms a micro-cavity. At this point, the telescope is advanced with necessary rotatory movements of the 30 degrees telescope guided by the vision of the dark spot which is the internal os. If it is reached, again waiting for some time to allow fluid distension of the internal os area.

Cervical probing is started with a 2 mm probe after grasping the cervix with a multi-tooth tenaculum put anteriorly or posteriorly according to prior transabdominal or transvaginal sonographic examination of the cervical canal. If the probe succeedes to bypass the internal os, a higher caliber probe is used. Thereafter, a uterine sound (4mm = 1.33 Fr) is introduced into the endometrial cavity. Lastly, gentle cervical dilatation up to Hegar's 8 is performed as usual with classic leaving each dilator for 30 seconds inside the internal os. If probes couldn't bypass the internal os, the procedure is considered failed. If the probe enters a cavity other than endometrial cavity, a false passage is considered.

Outcomes

Primary Outcome Measures

How many cases of access to the endometrial cavity
overcoming cervical stenosis

Secondary Outcome Measures

complication rate
how many cases with perforation or false passage

Full Information

First Posted
February 22, 2018
Last Updated
April 26, 2022
Sponsor
Woman's Health University Hospital, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT03457350
Brief Title
Office Hysteroscopy Versus Cervical Probing for Cervical Stenosis
Official Title
Small-caliber Office Hysteroscopy Versus Blind Cervical Probing for Tight Primary Cervical Stenosis in Nulliparous Women: a Preliminary Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2012 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Woman's Health University Hospital, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hysteroscopy
Keywords
hysteroscopy, cervical stenosis, probing

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
office hysteroscopy
Arm Type
Experimental
Arm Description
Office hysteroscopy 30 degrees 2.6 mm telescope with an outer sheath of 3.2 mm (Storz Co., Tutlingen, Germany). Hysteroscopy is performed as usual by proper examination of the vagina and the ectocervix for any abnormality followed by introduction of the hysteroscope into the cervical canal. At this step, the hysteroscopist waits for a while until the distending fluid forms a micro-cavity. At this point, the telescope is advanced with necessary rotatory movements of the 30 degrees telescope guided by the vision of the dark spot which is the internal os. If it is reached, again waiting for some time to allow fluid distension of the internal os area.
Arm Title
blind cervical probing
Arm Type
Experimental
Arm Description
Cervical probing is started with a 2 mm probe after grasping the cervix with a multi-tooth tenaculum put anteriorly or posteriorly according to prior transabdominal or transvaginal sonographic examination of the cervical canal. If the probe succeedes to bypass the internal os, a higher caliber probe is used. Thereafter, a uterine sound (4mm = 1.33 Fr) is introduced into the endometrial cavity. Lastly, gentle cervical dilatation up to Hegar's 8 is performed as usual with classic leaving each dilator for 30 seconds inside the internal os. If probes couldn't bypass the internal os, the procedure is considered failed. If the probe enters a cavity other than endometrial cavity, a false passage is considered.
Intervention Type
Procedure
Intervention Name(s)
cervical negotiation
Intervention Description
trial to bypass severe cervical stenosis
Primary Outcome Measure Information:
Title
How many cases of access to the endometrial cavity
Description
overcoming cervical stenosis
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
complication rate
Description
how many cases with perforation or false passage
Time Frame
20 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atef Darwish
Organizational Affiliation
Woman's |Health University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Woman's Health University Hospital
City
Assiut
ZIP/Postal Code
71111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Office Hysteroscopy Versus Cervical Probing for Cervical Stenosis

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