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. The purpose of this single blind control trial study was to assess whether the location of the balloon catheter either the uterus or cervix during sonohysterography could affect the magnitude of pain and the rate of vasovagal reaction. The proposal of study approved by our institutional review boards and institution’s ethical committee, and all participants sign a written consent before enter to study. A total of 300 infertile women aged, 18- 45 years, undergoing sonohysterography were randomized to intrauterine or intracervical balloon catheter placement. The examinations were scheduled in the early follicular phase of menstrual cycle after cessation of menstrual flow and before day 10. After introduction of a 2 lumen 6-French balloon catheter, under sonographic guidance, sterile normal saline solution (10-50 mL) was slowly introduced into the cavity until an adequate distention of the uterine cavity was obtained. Three-dimensional ultrasound scanned volumes were recorded. Scanned volumes were evaluated in multiplanar 3D and Multi-slice view mode, with slice interval of 0.5 mm. Visual analogue scales were used to assess the degree of pain experienced.Outcome measures were assessed based on the intent-to-treat principle.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201309053553N1
Registration date:2013-10-30, 1392/08/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-10-30, 1392/08/08
Registrant information
Name
Fatemeh Zafarani
Name of organization / entity
Royan institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2356 2446
Email address
fzafarani@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Royan Institute
Expected recruitment start date
2012-04-30, 1391/02/11
Expected recruitment end date
2013-09-30, 1392/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Pain perception and side effects during sonohysterography with balloon catheters: a randomized comparative study of cervical with uterine catheter placement
Public title
Optimal catheter placement during sonohysterography
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Infertile patients who are referred to Royan Institute and undergoing sonohysterography for evaluation of the internal structure of uterine cavity (acquired & congenital abnormalities).
Exclusion criteria: Symptoms or signs of active pelvic infection, Abnormal uterine bleeding ,Women with cervical stenosis, Women with each lesions which disrupts catheterization such as large myoma, Risk factors for endometrial cancer
from inflation of balloon catheter till 30 minutes after deflation
Method of measurement
touching of pulse , sphygmomanometer, observation of respiration , Termometer
Secondary outcomes
1
Description
Total time required to perform of sonohysterography
Timepoint
During of sonohysterography
Method of measurement
Recording of total time of sonohysterography
2
Description
Spontaneous catheter expulsion rate
Timepoint
During of sonohysterography
Method of measurement
Re-Catheter placement rate
3
Description
volume of media required to perform procedure
Timepoint
During of sonohysterography
Method of measurement
Measuring of volume of injected media during sonohysterography
Intervention groups
1
Description
Intervention group: In this group after introduction of speculum, balloon catheter was inflated in the uterine cavity. Then under sonographic guidance, sterile normal saline (10-50 mL) was slowly introduced into the cavity.When optimal distention of the uterine cavity was obtained, three-dimenstional volume sweep of the sagital, transverse and cronal coronal planes of the uterus were performed.
Category
Diagnosis
2
Description
Control group: In this group after introduction of speculum, balloon catheter was inflated in the cervical canal. Then under sonographic guidance, sterile normal saline (10-50 mL) was slowly introduced into the cavity.When optimal distention of the uterine cavity was obtained, three-dimenstional volume sweep of the sagital, transverse and cronal coronal planes of the uterus were performed.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Royan Institute
Full name of responsible person
Fatemeh Zafarani , Midwife, M.Sc. Academic staff of Reproductive Imaging Department
Street address
Department of Reproductive Imaging at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, ACECR [ P.O.Box: 1935-4644, No.12, Eastern Hafez Avenue, Banihashem Street, Resalat Highway]
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Royan Institute
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Royan institute
Full name of responsible person
Firoozeh Ahmadi
Position
Radiologist- Head of Department of Reproductive Imaging
Other areas of specialty/work
Street address
Department of Reproductive Imaging at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR [ P.O.Box: 1935-4644, No.12, Eastern Hafez Avenue, Banihashem Street, Resalat Highway]
City
Tehran
Postal code
1665659711
Phone
+98 21 2356 2446
Fax
+98 21 2356 2172
Email
dr.ahmadi1390@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Fatemeh Zafarani
Position
Midwife, M.Sc.,Scientific staff of Department of Reproductive imaging
Other areas of specialty/work
Street address
Department of Reproductive Imaging at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR [P.O.Box: 1935-4644,No.12, Eastern Hafez Avenue, Bani Hashem Street, Resalat Highway]
City
Tehran
Postal code
1665659711
Phone
+98 21 2356 2446
Fax
+98 21 2356 2172
Email
fzafarani@royaninstitute.org;f_zafarani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Saeed Hesam
Position
Biostatistics , M.Sc.
Other areas of specialty/work
Street address
Department of Epidemiology and Reproductive Health at Reproductive Epidemiology Research Center, Royan Institute for Reproductive Biomedicine, ACECR [ P.O.Box: 1935-4644, No.12, Eastern Hafez Avenue, Banihashem Street, Resalat Highway]
City
Tehran
Postal code
1665659711
Phone
+98 21 2356 2683
Fax
+98 21 2356 2172
Email
saeed_hesam65@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)