Optimal Balloon Catheter Placement During Sonohysterography
- Conditions
- Infertility
- Interventions
- Device: sonohysterography with inflated catheter in uterine cavityDevice: sonohysterography with inflated catheter in cervical cavity
- Registration Number
- NCT01936116
- Lead Sponsor
- Royan Institute
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 300
- 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.
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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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description patients with intrauterine balloon catheter placement sonohysterography with inflated catheter in uterine cavity In this group, during the procedure of sonohysterography balloon catheter is inflated in the uterine cavity patients with intracervical balloon catheter placement sonohysterography with inflated catheter in cervical cavity During the procedure of sonohysterography balloon catheter is inflated in the cervical canal
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (1)
Royan Institute
🇮🇷Tehran, Iran, Islamic Republic of