Optimal Balloon Catheter Placement During Sonohysterography

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

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Device: sonohysterography with inflated catheter in uterine cavity; Device: sonohysterography with inflated catheter in cervical cavity

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Royan Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Royan Institute
• Investigators: 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

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (ACTUAL): September 1, 2013
• Study Completion (ACTUAL): October 1, 2013

Study Registration Dates

• First Submitted: August 25, 2013
• First Submitted That Met QC Criteria: September 1, 2013
• First Posted (ESTIMATE): September 5, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): May 6, 2014
• Last Update Submitted That Met QC Criteria: May 4, 2014
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: vasovagal reaction; Sonohysterography; catheter placement; pain magnitude
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: Royan-Emb-016