Objectives: To determine the effect of Rosa canina capsules on the incidence of urinary tract infection in the puerperal period in women have C-section.
Design: Two-arm, randomized, triple-blind, controlled trial (the assessor, participants, and data analyser will be unaware of the type of intervention given to every participant).
Conduct: This trial will be conducted on 400 women (200 in each group) hospitalized after cesarean delivery in Alzahra and Taleghani therapeutic and educational centers in Tabriz. After obtaining written informed consent from eligible individuals, urine samples will be taken for urine culture. If they do not have asymptomatic bacteriuria, they will be enrolled in the study. Participants will be randomly assigned to two groups of intervention (receiving Rosa canina capsules) and control (receiving placebo) using block randomization with block sizes of 4 and 6 the allocation ratio of 1:1.
Participants: Delivered women by cesarean section with a catheter in the past 48 hours.
Intervention: The intervention group will receive two capsules containing Rosa canina and the control group will receive two capsules containing starch (placebo) daily from 48 hours to 20 days after cesarean section.
The main outcome variable include incidence rate of urinary tract infection during 20 days after a cesarean section. The secondary outcome variables include the incidence rate of asymptomatic bacteriuria in 7-10 days and 20 days after cesarean section and incidence rate of cystitis and pyelonephritis during 20 days after cesarean section.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016040910324N30
Registration date:2016-08-28, 1395/06/07
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-08-28, 1395/06/07
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-09-10, 1395/06/20
Expected recruitment end date
2017-01-09, 1395/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effect of Rosa canina capsules on the incidence of urinary tract infection in the puerperium: a randomized controlled trial
Public title
Determining the effect of Rosa canina capsules on the incidence of urinary tract infection in the puerperium
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Having a cesarean section in the last 48 hours; Taking of three doses of antibiotics after surgery; Having willingness to participate in the study; Having phone number for follow-up; Not participate in other similar studies.
Exclusion criteria: Having symptoms of urinary tract infections; Specific conditions that need to take antibiotics after discharge; Using of immunosuppressive drugs and related drugs to the respiratory system; Lack of catheterization during cesarean section
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
400
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz Univercity of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East azerbaijan
City
Tabriz
Postal code
Approval date
2016-06-20, 1395/03/31
Ethics committee reference number
IR.TBZMED.REC.1395.231
Health conditions studied
1
Description of health condition studied
Urinary tract infection following delivery
ICD-10 code
O86.2
ICD-10 code description
Urinary tract infection following delivery
Primary outcomes
1
Description
The incidence of urinary tract infection (UTI)
Timepoint
7-10 and 20 days after cesarean section
Method of measurement
Urine culture and checklist of urinary infection symptoms
Secondary outcomes
1
Description
Side events
Timepoint
During the study
Method of measurement
Checklist of side events
2
Description
The incidence of pyelonephritis
Timepoint
During 20 days after cesarean
Method of measurement
Urine culture and checklist of urinary infection symptoms
3
Description
The incidence of cystitis
Timepoint
During 20 days after cesarean
Method of measurement
Urine culture and checklist of urinary infection symptoms
4
Description
The incidence of asymptomatic bacteriuria
Timepoint
7-10 days and 20 days after cesarean
Method of measurement
Urine culture
Intervention groups
1
Description
The intervention group will receive two capsules of 500 mg Rosa canina daily ½ hours after two meals (breakfast and dinner) orally with a full glass of water for 18 days.
Category
Treatment - Drugs
2
Description
The intervention group will receive two capsules of 500 mg placebo (containing starch) daily ½ hours after two meals (breakfast and dinner) orally with a full glass of water for 18 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
AlzahraTherapeutic Educational Center
Full name of responsible person
Mahdieh Seifi
Street address
Baghshmal intersection, South army street, Tabriz
City
Tabriz
2
Recruitment center
Name of recruitment center
Talegani Therapeutic Educational Center
Full name of responsible person
Mahdieh Seifi
Street address
Railway Square, 22 Bahman street, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Rashidi
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East Azerbaijan
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sciences
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
Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Mahdieh Seifi
Position
MSc Student of Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South Shariati street
City
Tabriz
Postal code
5451796499
Phone
+98 41 4422 1874
Fax
Email
seifimah@gmail.com
Web page address
http://nursing.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Mojgan Mirghafourvand
Position
Assistante Professor, PhD of Reproductive Health
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
Email
Mirghafourvandm@tbzmed.ac.ir; mirg1385@yahoo.com
Web page address
http://nursing.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursind & Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Mahdieh Seifi
Position
Msc Student of Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Postal code
5451796499
Phone
+98 41 4422 1874
Fax
Email
seifimah@gmail.com
Web page address
http://nursing.tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)