Optimal Balloon Catheter Placement During Sonohysterography

Sponsor

Royan Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01936116

Collaborator

(none)

300

Enrollment

Location

Arms

Duration (Months)

17.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Device: sonohysterography with inflated catheter in uterine cavity Device: sonohysterography with inflated catheter in cervical cavity	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: patients with intrauterine balloon catheter placement

In this group, during the procedure of sonohysterography balloon catheter is inflated in the uterine cavity

Device: sonohysterography with inflated catheter in uterine cavity

during the procedure of sonohysterography balloon catheter is inflated in the uterine cavity

Active Comparator: patients with intracervical balloon catheter placement

During the procedure of sonohysterography balloon catheter is inflated in the cervical canal

Device: sonohysterography with inflated catheter in cervical cavity

During the procedure of sonohysterography balloon catheter is inflated in the cervical canal

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Saline volume [during sonohysterography]
Evaluation the saline volume that is required for sonohisterography
time of procedure [during sonohysterography]
Evaluation the total time that is needed for sonohysterography.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royan Institute	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

Royan Institute

Investigators

Study Chair: Hamid Gourabi, PhD, Head of Royan Institute
Study Director: Fatemeh Zafarani, MSc, Department of Reproductive Imaging at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine
Principal Investigator: Firoozeh Ahmadi, MD, Department of Reproductive Imaging at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine