Comparison of early and immediate oral hydration on post-cesarean section outcome
Design
This single-blind randomized clinical trial with parallel groups (Third phase) will be performed on 26 women undergoing cesarean section with spinal anesthesia. In this study, block randomization method will be used. Random allocation software is also used to generate a random sequence of blocks. In the intervention group, oral fluid therapy for patients will begin during the first two hours after surgery. In the control group, oral feeding will be started within six hours after surgery.
Settings and conduct
This single-blind randomized clinical trial study with parallel groups will be performed on 26 women undergoing cesarean section with spinal anesthesia in Zanjan academic hospital. In this study, data collectors, outcome assessors, and manuscript writers will be completely unaware of the drug prescribing protocol. In the intervention group, oral fluid therapy for patients will begin during the first two hours after surgery. In the control group, oral feeding will be started within six hours after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria include pregnant women undergoing cesarean section under spinal anesthesia. Patients with a history of HTN, heart disease, body mass index more than 30 and people with preeclampsia will be excluded.
Intervention groups
In the intervention group, oral fluid therapy for patients will begin during the first two hours after surgery.
Main outcome variables
hospital stay length
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220517054893N1
Registration date:2022-05-25, 1401/03/04
Registration timing:prospective
Last update:2022-05-25, 1401/03/04
Update count:0
Registration date
2022-05-25, 1401/03/04
Registrant information
Name
Aida Rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3335 3053
Email address
aida.rezaei@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-02, 1401/04/11
Expected recruitment end date
2023-01-01, 1401/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of early and immediate oral hydration on post-cesarean section outcome
Public title
Comparison of early and immediate oral hydration on post-cesarean section outcome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women undergoing cesarean section by spinal anesthesia
Exclusion criteria:
Hypertention
Body mass index more than 30
Preeclampsia
Heart disease
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the block randomization method. The size of all blocks is equal. Random allocation software is also used to generate a random sequence of blocks.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, data collectors, outcome assessors, and manuscript writers will be completely unaware of the prescribing protocol.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Jomhori BLV. Azadi Squ. Zanjan
City
zanjan
Province
Zanjan
Postal code
1435689752
Approval date
2022-05-10, 1401/02/20
Ethics committee reference number
IR.ZUMS.REC.1401.052
Health conditions studied
1
Description of health condition studied
Hospital stay length
ICD-10 code
O75.82
ICD-10 code description
Onset (spontaneous) of labor after 37 completed weeks of gestation but before 39 completed weeks gestation, with delivery by (planned) cesarean section
Primary outcomes
1
Description
Hospital stay length
Timepoint
Days of hospitalization after surgery
Method of measurement
Based on day
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, oral fluid therapy for patients will begin during the first two hours after surgery.
Category
Treatment - Drugs
2
Description
Control group: In the control group, oral fluid therapy for patients will begin during the six hours after surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital in Zanjan
Full name of responsible person
Aida Rezaei
Street address
Ayatollah Mousavi Hospital, Gavazang Road, Zanjan
City
Zanjan
Province
Zanjan
Postal code
1425678922
Phone
+98 21 8806 4148
Email
aida.rezaei@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Samad Nadri
Street address
Zanjan University of Medical Sciences Campus, Dr. Yousef Sabouti Blvd., Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3301 8100
Email
riasat@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Aida Rezaei
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ayatollah Mousavi Hospital, Gavazang Road, Zanjan
City
Zanjan
Province
Zanjan
Postal code
1425678922
Phone
+98 21 8806 4148
Email
aida.rezaei@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Aida Rezaei
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ayatollah Mousavi Hospital, Gavazang Road, Zanjan
City
Zanjan
Province
Zanjan
Postal code
1425678922
Phone
+98 21 8806 4148
Email
aida.rezaei@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Aida Rezaei
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ayatollah Mousavi Hospital, Gavazang Road, Zanjan
City
Zanjan
Province
Zanjan
Postal code
1425678922
Phone
+98 21 8806 4148
Email
aida.rezaei@zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data including the main and secondary outcomes can be shared.
When the data will become available and for how long
Access period starts from 2023
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Raw data is not available to individuals and upon request, the results of the requested statistical analysis will be available to individuals.
From where data/document is obtainable
Contact Dr. Aida Rezaei (aida.rezaei@zums.ac.ir) at Zanjan University to receive the required documents or data.
What processes are involved for a request to access data/document
To submit a request, it is enough to contact the mentioned expert and send a written and signed request to her.