Optimal Balloon Catheter Placement During Sonohysterography

Study Overview
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Brief Summary
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Saline infusion sonohysterography and other intrauterine investigations methods may cause uterine cramping, pain and vasovagal reactions. According to few of previous studies the position of catheter placement can affect the magnitude of pain and amount of saline required during the sonohysterography. The purpose of this double blind control trial study is to assess whether the location of the balloon catheter either the uterus or cervix during sonohysterography can affect the magnitude of pain and the rate of vasovagal reaction.

Detailed Description
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The proposal of study approved by the investigators institutional review boards and institution's ethical committee, and all participants will sign a written consent before enter to study. A total of 300 infertile women undergoing sonohysterography will be randomized to intrauterine or intracervical balloon catheter placement. The examination is scheduled in the early follicular phase of menstrual cycle, immediately after cessation of menstrual flow and before day 10. After preparation of patient, a 2 lumen 6-French flexible catheter is introduced into the cervical canal and balloon at the catheter tip is placed in the lower uterine segment or 1 cm into cervical canal and inflated with 1 mL of sterile saline solution. Under sonographic guidance, sterile normal saline solution (10-50 mL) is slowly introduced into the cavity until an adequate distention of the uterine cavity is obtained. Three-dimensional ultrasound scanned volumes are recorded. Patients are asked to assess their level of pain at the time of the balloon inflation and deflation using a 10-point visual analog pain scale. Patients are checked for the sign and symptoms of vasovagal reaction during and 30 minutes after procedure. Outcome measures will be assessed based on the intent-to-treat principle.

Official Title
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Pain Perception and Side Effects During Sonohysterography With Balloon Catheters: a Randomized Comparative Study of Cervical With Uterine Catheter Placement

Conditions
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Infertility

Intervention / Treatment
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* Device: sonohysterography with inflated catheter in uterine cavity
* Device: sonohysterography with inflated catheter in cervical cavity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infertile patients who will be referred to Royan institute for sonohysterography to evaluate the internal structure of uterine cavity (acquired & congenital abnormalities) are included in this prospective comparative study. Exclusion Criteria: Exclusion Criteria: Symptoms of active pelvic infection Abnormal uterine bleeding Women with cervical stenosis Women with each lesions which disrupts catheterization such as large myoma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with intrauterine balloon catheter placement<br>In this group, during the procedure of sonohysterography balloon catheter is inflated in the uterine cavity | Device: sonohysterography with inflated catheter in uterine cavity<br>* during the procedure of sonohysterography balloon catheter is inflated in the uterine cavity<br>|
| Active Comparator: patients with intracervical balloon catheter placement<br>During the procedure of sonohysterography balloon catheter is inflated in the cervical canal | Device: sonohysterography with inflated catheter in cervical cavity<br>* During the procedure of sonohysterography balloon catheter is inflated in the cervical canal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perceived Pain | inflation of the balloon & deflation of the balloon by a 10-point visual analog pain scale | during sonohysterography | 
| Vasovagal reactions | Evaluation the vasovagal reactions (Hypotension, vomiting, syncope)in patients During procedure . | During sonohysterography | 
| vasovagal reaction | Evaluation the vasovagal reactions (Hypotension, vomiting, syncope)in patients 30 minutes after procedure . | 30 minutes after sonohysterography | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Saline volume | Evaluation the saline volume that is required for sonohisterography | during sonohysterography | 
| time of procedure | Evaluation the total time that is needed for sonohysterography. | during sonohysterography | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sonohysterography, catheter placement, pain magnitude, vasovagal reaction