This is a one-way and Parallel single blind study. Our aim is to compare the effectiveness of tamsulosin with placebo in preventing urinary retention after cesarean section. Our study population, patients referring to Shahidan Mobinabi Hospital Sabzevar, with age criteria up to 40 years old who are electively undergoing cesarean section surgery. Patients are randomly on random blocks assigned to control and control groups. After receiving consent, patients receive three doses of tamsulosin. Three doses of placebo will be given to the control group. They are then examined within 24 hours of surgery. Information is collected on the basis of a check list prepared. In case of complaints of urinary retention, the nalton catheter would be manipulated; then urinary retention is considered if there is a urinary volume of more than 200 cc. The information obtained by the software is then analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017092036287N1
Registration date:2017-10-21, 1396/07/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-21, 1396/07/29
Registrant information
Name
Alireza Abadi
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 8000
Email address
abadia89@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Sabzevar University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Tamsulosin in prevention of post Cesarean Section urinary retention
Public title
Effect of Tamsulosin on prevention of post-operative urinary retention
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All patients under 40 years of age who are referred to Mobinin Hospital in Sabzevar for elective cesarean section
Exclusion criteria: Emergency cesarean section; Serum volume received more than 1000 cc before surgery; Pre-eclampsia; age over 40 years; history of neurological disease; history of Gynecologic surgery; preoperative urinary symptoms; Alpha blocker use before the operation
Age
From 15 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
152
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In the study, patients are randomly assigned to either intervention or control group after entering the study. It is then to be be explained to them how a medicine is procured to prevent urinary retention. The side effects of the medicine is be fully explained aftetwards. None of the patients are aware of which group they may receive and the type of medication they would receive; as a result, this is a blinded study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Savzevar University of Medical Sciences
Street address
Asad Abadi Street, Central Organization of Medical Sciences, Sabzevar
City
Sabzevar
Postal code
Approval date
2017-07-10, 1396/04/19
Ethics committee reference number
IR.MEDSAB.REC.1396.24
Health conditions studied
1
Description of health condition studied
Urinary retention
ICD-10 code
N32.0
ICD-10 code description
Bladder-neck obstruction
Primary outcomes
1
Description
Urinary retention
Timepoint
After the intervention
Method of measurement
History and volume of urine after catheterization
Secondary outcomes
1
Description
hypotension
Timepoint
24 hours after intervention
Method of measurement
In millimeters of mercury using a mercuric pressure gauge
Intervention groups
1
Description
Intervention group: Tamsulosin portal 0.4 mg, oral, 3 doses, one day, 6 hours before surgery, during surgery and 6 hours after surgery.
Category
Treatment - Drugs
2
Description
Control group: placebo, 3 doses, for a day, 6 hours before surgery, during surgery and 6 hours after surgery.