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Office Hysteroscopy Versus Cervical Probing for Cervical Stenosis

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ClinicalTrials.gov Identifier: NCT03457350
Recruitment Status : Completed
First Posted : March 7, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Professor Atef Darwish, Woman's Health University Hospital, Egypt

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, we test the impact of drawing a detailed diagram after this procedure on the success of ET in patients with failed mock or actual trials of embryo transfer (ET).

Condition or disease Intervention/treatment Phase
Hysteroscopy Procedure: cervical negotiation Not Applicable

Detailed Description:
It comprises 122 nulliprous women with failed cervical sounding on vaginal examination in the office. Women 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 Type : Interventional  (Clinical Trial)
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 : January 1, 2012
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

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




Primary Outcome Measures :
  1. How many cases of access to the endometrial cavity [ Time Frame: 20 minutes ]
    overcoming cervical stenosis


Secondary Outcome Measures :
  1. complication rate [ Time Frame: 20 minutes ]
    how many cases with perforation or false passage



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • nulliprous women with failed cervical sounding on vaginal examination in the office.

Exclusion Criteria:

  • There shouldn't be any previous operation on the cervix nor use of any medication to prime the cervix (primary). Multiparity is an exclusion criterion to eliminate any bias due to previous cervical dilatation, even multiparous women delivered by cesarean section were excluded to exclude patient heterogeneity.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03457350


Locations
Egypt
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

Responsible Party: Professor Atef Darwish, Professor Dr Atef Darwish MD PhD, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier: NCT03457350     History of Changes
Other Study ID Numbers: hysteroscopy versus probing
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Professor Atef Darwish, Woman's Health University Hospital, Egypt:
hysteroscopy
cervical stenosis
probing

Additional relevant MeSH terms:
Constriction, Pathologic
Pathological Conditions, Anatomical