Office Hysteroscopy Versus Cervical Probing for Cervical Stenosis

NCT ID: NCT03457350

Last Updated: 2022-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-01
• Study Completion Date: 2018-02-28

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

Conditions

Hysteroscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

cervical negotiation

Intervention Type: PROCEDURE

trial to bypass severe cervical stenosis

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.

Group Type: EXPERIMENTAL

cervical negotiation

Intervention Type: PROCEDURE

trial to bypass severe cervical stenosis

Interventions

cervical negotiation

trial to bypass severe cervical stenosis

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Woman's Health University Hospital, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Professor Atef Darwish

Professor Dr Atef Darwish MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Atef Darwish

Role: PRINCIPAL_INVESTIGATOR

Woman's |Health University Hospital

Locations

Woman's Health University Hospital

Asyut, , Egypt

Countries

Egypt

Other Identifiers

hysteroscopy versus probing

Identifier Type: -

Identifier Source: org_study_id