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Effect of early-start nutrition (after 2hr) versus delayed-start nutrition (after 8hr) on gastrointestinal complications and patients satisfaction after cesarean surgery

Protocol summary

Summary
Two hundred pregnant women who undergo Cesarean section will be recruited and divided in two groups. This study and its probable complications will be explained for all eligible women and inform consent will be taken. Type of anesthesia in 2 groups is the same (Both are spinal anesthesia). In early-start nutrition group, liquids will be begun after 2 hours, and if they tolerate, semi-solid & solid diet will be continued. In delayed-Start nutrition group, liquid will be started 8 hours after operation and if they tolerate, semi-solid & solid diet will be continued. Finally, incidence of vomiting, time of intestinal sound establishment (hr) ,time of gas ejection (hr), time of stool ejection , beginning of normal diet (hr), duration of admission to discharge and also patient satisfaction will be determined by themselves in both groups. The points that we should note in questionnaire consist of : demographic data such as age, BMI, pregnancy age, type of section(transvers or vertical), duration of operation, adhesion amount and urinary output.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138712211760N1
Registration date: 2009-09-09, 1388/06/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2009-09-09, 1388/06/18
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Expected recruitment start date
2009-04-21, 1388/02/01
Expected recruitment end date
2009-12-22, 1388/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of early-start nutrition (after 2hr) versus delayed-start nutrition (after 8hr) on gastrointestinal complications and patients satisfaction after cesarean surgery
Public title
Effect of early-start nutrition (after 2hr) versus delayed-start nutrition (after 8hr) on gastrointestinal complications and patients satisfaction after cesarean surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women that will undego Cesarean section and aged 18-40 yr. Exclusion criteria: history of gastrointestinal disease such as: intestine occlusion, stomach surgery, intestinal surgery, adhesion and intestinal manipulation repair; Obstetrics complications such as: pregnancy fat liver, placenta abruption, chorioamnionitis, preeclamcia; surgery complications such as: server hemorrhage.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The ethics committee of Babol University of Medical sciences
Street address
Gangafroz Avenue
City
Babol
Postal code
4717641367
Approval date
2008-03-08, 1386/12/18
Ethics committee reference number
RV/11

Health conditions studied

1

Description of health condition studied
Cesarean section surgery complication
ICD-10 code
O94
ICD-10 code description
Sequelae of complication of pregnancy, childbirth and the puerperium

2

Description of health condition studied
Nutrition after Cesarean section
ICD-10 code
O99
ICD-10 code description
Other maternal diseases classifiable elsewhere but complicating pregnancy, childbirth and the puerperium

Primary outcomes

1

Description
borborygmi time
Timepoint
the hours after the nutrition
Method of measurement
physical exam

2

Description
vomiting, gas passing time, defication time, time of start of normal diet
Timepoint
the hours after the nutrition
Method of measurement
question

3

Description
Patient satisfaction
Timepoint
release time
Method of measurement
visual analog scale [from zero ( nonsatisfaction ) to 100 ( full satisfaction)]

4

Description
duration of admission
Timepoint
release time
Method of measurement
hours

Secondary outcomes

1

Description
urinary output
Timepoint
from nutrition time up to 24 hr (every 4 hr)
Method of measurement
millilitre

Intervention groups

1

Description
delayed-start nutrition (after 8hr ) as control group
Category
Other

2

Description
early-start nutrition (after 2hr) as intervention group
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Yahyanejad Hospital
Full name of responsible person
Dr. seddigheh esmaeilzadeh
Street address
Yahyanejad Hospital, Babol
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Full name of responsible person
Ali bijani
Street address
Gangafroz Avenue
City
Babol
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 and Technology, Babol 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
Fatemehzahra Fertility & reproductive Health Reseach Center
Full name of responsible person
Nargess Gholizadeh Pasha
Position
M.A/responsible of Reseach Center
Other areas of specialty/work
Street address
Fatemehzahra Fertility & reproductive Health Reseach Center - noshirvani street
City
Babol
Postal code
4719173716
Phone
+98 71112274881
Fax
+98 11 1227 4880
Email
ngh_pa@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Fatemehzahra Fertility & reproductive Health Reseach Center
Full name of responsible person
Seddigheh esmaeilzadeh
Position
responsible of fatemehzahra Fertility & reproductive Health Reseach Center/Gynecologist
Other areas of specialty/work
Street address
Fatemehzahra Fertility & reproductive Health Reseach Center - noshirvani steert
City
Babol
Postal code
4719173716
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
sesmael@yahoo.com
Web page address
www.fatemehzahra.ir

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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