Thin Catheter for Hysterosalpigography

Hysterosalpigography Using a Thin Catheter and Closing the Cervix With the Vaginal Speculum to Reduce the Pain

Hysterosalpingography is usually painful and the use of thin catheters of IUI could be an attractive alternative . we conducted a randomised controlled trial to compare the standard metal cannula to the thin catheter originally manufactured for intrauterine insemination. Pain assessment was done using visual analogue scale

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Device: HSG cannula

Detailed Description

HSG is widely practiced in our country, however, for cost effective reasons, the standard metal cannula is the only method used at our hospital. It is painful procedure because it requires grasping the cervix with a tenaculum and inducing some cervical dilatation during introduction of the cannula. The aim of this pilot study was to modify the technique of HSG using a thinner than normal catheter, and without grasping the cervix with a tenaculum. Leakage of the dye through the cervix was prevented by pressing on the portiovaginalis of the cervix using the vaginal speculum.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• infertile women seeking evaluation of fallopian tubes

Exclusion Criteria:

• any woman with allergy to the iodine dye or condition contraindicating pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: infertile women; infertile women undergoing hysterosalpingography for evaluating fallopian tubes

Device: HSG cannula; a thin catheter originally designed for IUI was introduced through the cervical canal into the lower part of the uterine cavity. After introducing the catheter, the screw of the vaginal speculum was loosened to allow the two valves of the speculum to press on the portiovaginalis of the cervix to prevent leakage of the dye. Then the dye was injected slowly and the procedure was watched on the screen and x-ray films were taken.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the level of pain using a visual analogue scale (VAS)	pain score will be assessed during introduction of catheter and during the injection of dye	8 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visualising uterus and tubes	the efficiency of the new technique in filling the uterine cavity with the dye and studying fallopian tubes.	8 month

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: July 11, 2011
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (Actual): February 1, 2019

Study Record Updates

• Last Update Posted (Actual): February 1, 2019
• Last Update Submitted That Met QC Criteria: January 30, 2019
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Keywords: hysterosalpingography, catheter, pain, visual analogue scale
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 1-Mansour