Office Hysteroscopy Versus Cervical Probing for Cervical Stenosis

Sponsor

Woman's Health University Hospital, Egypt (Other)

Overall Status

Completed

CT.gov ID

NCT03457350

Collaborator

(none)

128

Enrollment

Location

Arms

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Hysteroscopy	Procedure: cervical negotiation	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Feb 1, 2018

Actual Study Completion Date :

Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: office hysteroscopy 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.	Procedure: cervical negotiation trial to bypass severe cervical stenosis
Experimental: blind cervical probing 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.	Procedure: cervical negotiation trial to bypass severe cervical stenosis

Arm

Intervention/Treatment

Experimental: office hysteroscopy

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.

Procedure: cervical negotiation

trial to bypass severe cervical stenosis

Experimental: blind cervical probing

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.

Procedure: cervical negotiation

trial to bypass severe cervical stenosis

Outcome Measures

Primary Outcome Measures

How many cases of access to the endometrial cavity [20 minutes]
overcoming cervical stenosis

Secondary Outcome Measures

complication rate [20 minutes]
how many cases with perforation or false passage

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Woman's Health University Hospital	Assiut		Egypt	71111

Sponsors and Collaborators

Woman's Health University Hospital, Egypt

Investigators

Principal Investigator: Atef Darwish, Woman's |Health University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Professor Atef Darwish, Professor Dr Atef Darwish MD PhD, Woman's Health University Hospital, Egypt

ClinicalTrials.gov Identifier:

NCT03457350

Other Study ID Numbers:

hysteroscopy versus probing

First Posted:

Mar 7, 2018

Last Update Posted:

May 3, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Professor Atef Darwish, Professor Dr Atef Darwish MD PhD, Woman's Health University Hospital, Egypt

hysteroscopy

cervical stenosis

probing

Additional relevant MeSH terms:

Constriction, Pathologic

Study Results

No Results Posted as of May 3, 2022