Clinical trial NCT01936116: Optimal Balloon Catheter Placement During Sonohysterography
Official title: Pain Perception and Side Effects During Sonohysterography With Balloon Catheters: a Randomized Comparative Study of Cervical With Uterine Catheter Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Keywords: Sonohysterography
catheter placement
pain magnitude
vasovagal reaction
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2013-09-05
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: perceived Pain
timeFrame: during sonohysterography
measure: Vasovagal reactions
timeFrame: During sonohysterography
measure: vasovagal reaction
timeFrame: 30 minutes after sonohysterography
Secondary outcomes:
measure: Saline volume
timeFrame: during sonohysterography
measure: time of procedure
timeFrame: during sonohysterography
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Department of Reproductive Imaging at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine
name: Fatemeh Zafarani, MSc
role: STUDY_DIRECTOR
affiliation: Department of Reproductive Imaging at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine
name: Firoozeh Ahmadi, MD
role: PRINCIPAL_INVESTIGATOR
References: