Optimal Balloon Catheter Placement During Sonohysterography

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01936116
• Other study ID #: Royan-Emb-016
• Status: Completed
• Phase: Phase 4
• First received: August 25, 2013
• Last updated: May 4, 2014
• Start date: May 2012
• Est. completion date: October 2013

Study information

• Verified date: February 2012
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• sonohysterography with inflated catheter in uterine cavity
during the procedure of sonohysterography balloon catheter is inflated in the uterine cavity
• sonohysterography with inflated catheter in cervical cavity
During the procedure of sonohysterography balloon catheter is inflated in the cervical canal

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	perceived Pain	inflation of the balloon & deflation of the balloon by a 10-point visual analog pain scale	during sonohysterography	Yes
Primary	Vasovagal reactions	Evaluation the vasovagal reactions (Hypotension, vomiting, syncope)in patients During procedure .	During sonohysterography	Yes
Primary	vasovagal reaction	Evaluation the vasovagal reactions (Hypotension, vomiting, syncope)in patients 30 minutes after procedure .	30 minutes after sonohysterography	Yes
Secondary	Saline volume	Evaluation the saline volume that is required for sonohisterography	during sonohysterography	Yes
Secondary	time of procedure	Evaluation the total time that is needed for sonohysterography.	during sonohysterography	Yes

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