1. Home
  2. Approved trials
  3. » فارسی

The effect of hospitalization time after elective cesarean section on maternal complications

Protocol summary

Study aim
Determining the effect of hospitalization time after elective cesarean section on maternal complications
Design
This study is a randomized clinical trial that will be performed on 294 women who undergo elective cesarean section surgery in the Gynecology ward of Imam Sajjad Hospital in Yasuj, Iran during 2018-2019.
Settings and conduct
Group A (hospitalization after cesarean for 24 hours) and group B (hospitalization after cesarean section for 48 hours). In both groups, during the first 24 hours, an intravenous antibiotic of cefazolin and pethidine intake will be prescribed at the time of pain. Patients will be discharged from the hospital with the hematinic and mefenamic acid.
Participants/Inclusion and exclusion criteria
Age less than 35, elective cesarean in previous pregnancy, non-underlying diseases such as immune system, diabetes, high blood pressure, heart disease, pulmonary and blood diseases, severe non-hemorrhage during surgery, no specific drug, single pregnancy , maternal BMI according weight before pregnancy under 30.
Intervention groups
Hospitalization after cesarean delivery for 24 hours compared to 48 hours.
Main outcome variables
cesarean site infection, separation of incision, endometritis, urinary tract infection, digestive complications, lactation, pain and satisfaction of the patient after surgery.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160524028038N3
Registration date: 2019-05-30, 1398/03/09
Registration timing: registered_while_recruiting

Last update: 2019-05-30, 1398/03/09
Update count: 0
Registration date
2019-05-30, 1398/03/09
Registrant information
Name
Fatemeh Bazarganipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3366 6367
Email address
bazarganipour@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-19, 1397/11/30
Expected recruitment end date
2019-07-21, 1398/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hospitalization time after elective cesarean section on maternal complications
Public title
The effect of hospitalization time after elective cesarean section on maternal complications
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age less than 35 Elective cesarean section in previous pregnancy Non-underlying diseases such as immune deficiency, diabetes, high blood pressure, heart disease, pulmonary and blood disorders Severe non-hemorrhage during surgery Non-use of special drug Single pregnancy Maternal BMI according to weight before pregnancy below 30
Exclusion criteria:
Lack of follow-up Unwillingness to participate in the study
Age
To 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 294
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple. The sealed envelopes were used.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
• No. 7916839319, Shahid Jalil Ave., Yasuj Town, kohgiluyeh and boyer-ahmad
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Approval date
2019-01-05, 1397/10/15
Ethics committee reference number
IR.YUMS.REC.1397.134

Health conditions studied

1

Description of health condition studied
cesarean section
ICD-10 code
O82.8
ICD-10 code description
Other single delivery by caesarean section

Primary outcomes

1

Description
incision infection
Timepoint
one and six weeks after discharge
Method of measurement
questionnaire

2

Description
separation of incision
Timepoint
one and six weeks after discharge
Method of measurement
questionnaire

3

Description
Endometritis
Timepoint
one and six weeks after discharge
Method of measurement
questionnaire

4

Description
urinary tract infection
Timepoint
one and six weeks after discharge
Method of measurement
questionnaire

5

Description
Digestive complications
Timepoint
one and six weeks after discharge
Method of measurement
questionnaire

6

Description
Lactation
Timepoint
one and six weeks after discharge
Method of measurement
questionnaire

7

Description
Postoperative pain
Timepoint
one and six weeks after discharge
Method of measurement
questionnaire

8

Description
postoperative satisfaction
Timepoint
one and six weeks after discharge
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Hospitalization after cesarean section for 24 hours
Category
Treatment - Other

2

Description
Control group: Hospitalization after cesarean section for 48 hours
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Yasuj University of Medical Sciences
Full name of responsible person
Leila Jamali
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
leilajml1389@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Hossein Mari-Oriad
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
leilajml1389@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Leila Jamali
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
leilajml1389@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Leila Jamali
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
leilajml1389@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Leila Jamali
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
leilajml1389@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...