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Effect of gum chewing and coffee consumption on intestinal motility in caesarean sections

Protocol summary

Study aim
Due to contradictory evidence in reducing the duration of Ileus after cesarean section, this study was designed to determine the effect of chewing gum and coffee and compare the two dimensions after cesarean section.
Design
Clinical trial with control group, parallel groups, double-blind, randomized with color card, on 150 patients.
Settings and conduct
The research will be performance in Alavi Hospital in Ardabil. In the three groups studied, the time of feeling the bowel movements and the time of passage of the first gas and excretion between the groups will be compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: primiparous, age between 35-38 years, BMI in the normal range, gestational age between 37-42, elective cesarean section, without use of specific drugs and without history of chronic systemic diseases Exclusion criteria: preterm delivery, multiple pregnancies, premature rupture of membranes, emergency cesarean section, body temperature above 38 degrees, severe anemia, history of surgery Abdominal other than cesarean section, allergic reaction to the materials used and inability to chew gum
Intervention groups
Patients were randomly divided into 3 groups based on the card color in the pocket: group 1 (women received turpentine gum 4 hours after surgery until the first defecation) 50 women, the second group (women 100 ml of coffee is given at 4-hour intervals starting from the second hour after surgery to the first bowel movement 3 times a day) 50 people and group 3 (control group) 50 people.
Main outcome variables
Time of first passage of the first gas of gut, Time of first passage of the first defecation, Time of first passage of the first the first gut sound

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210113050028N1
Registration date: 2021-02-12, 1399/11/24
Registration timing: prospective

Last update: 2021-02-12, 1399/11/24
Update count: 0
Registration date
2021-02-12, 1399/11/24
Registrant information
Name
Noushin Mobaraki-asl
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3323 5861
Email address
n.mobaraki@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-17, 1399/11/29
Expected recruitment end date
2021-04-18, 1400/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of gum chewing and coffee consumption on intestinal motility in caesarean sections
Public title
Effect of gum chewing and coffee consumption on intestinal motility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
BMI in normal range gestational age 37-42 Elective Cesarean section Do not use any special medicine No history of chronic systemic diseases
Exclusion criteria:
Preterm labour Multiple pregnancy premature rupture of memberan Emergency cesarean section (due to placental problems, chorioamnionitis, fetal distress, placental abnormalities, vaginal bleeding, etc.) Body temperature above 38 degrees Severe anemia History of abdominal surgery other than cesarean section Allergic reaction to the used materials Inability to chew gum
Age
From 13 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to eliminate the bias caused by the patient's knowledge and the clinical caregiver and evaluator, the patient is selected for the type of intervention and its possible impact on the research result of the study is done in a double-blind method.Given that the patient's choice and method of intervention is done using a color card, it is natural that the patient and the clinical caregiver and analyst will not interfere in choosing the type of intervention
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
Gynecology department, alavi hospital, Mogadas Ardabili Avenue,
City
Ardabil
Province
Ardabil
Postal code
5613974156
Approval date
2020-09-26, 1399/07/05
Ethics committee reference number
IR.ARUMS.REC.1399.420

Health conditions studied

1

Description of health condition studied
Intestinal motility and ileus in caesarean sections
ICD-10 code
O99
ICD-10 code description
Other maternal diseases classifiable elsewhere but complicating pregnancy, childbirth and the puerperium

Primary outcomes

1

Description
Intestinal motility
Timepoint
Patients will be visited every hour
Method of measurement
The time of the first bowel movements, the time of the first expulsion of gas, defecation and gut sound will be recorded.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1 : Chewing gum group: This group will chew 2 pieces of turpentine chewing gum 3 times a day (at least 3 hours, morning, noon, night) for a period of 15 minutes from 2 hours after surgery until defecation.
Category
Treatment - Other

2

Description
Intervention group 2 : Group 2 will be given 100 ml of coffee - 2 g (1 teaspoon) of decaffeinated coffee, without supplement (milk, sugar) - three times in day for at least 4 hours intervals until defecation after the start of the diet.
Category
Treatment - Other

3

Description
Control group: This group will not receive any intervention, only routine care.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Alavi Hospital
Full name of responsible person
Nooshin Mobaraki_asl
Street address
Varzesh Square, Mogadas ardabili Avenue
City
Ardabil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3323 5861
Email
n.mobaraki@arums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Farhad Pourfarzi
Street address
Varzesh square, Mogadas ardabili avenue
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 45 3353 4790
Email
n.mobaraki@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Ardabil University of Medical Sciences assistance of Research
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
Ardabil University of Medical Sciences
Full name of responsible person
Jinous Gamissi
Position
Research expert, midwifery teacher
Latest degree
Master
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Varzesh square, alavi hospital
City
Ardabil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3326 1714
Fax
Email
gamissijinous@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Noushin Mobaraki-asl
Position
Assistant professor of Oncology
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Varzesh square, alavi hospital, 5613974156
City
Ardabil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3323 5861
Fax
Email
n.mobaraki@arums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Jinous Gamissi
Position
midwife, midwifery teacher
Latest degree
Master
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Varzesh square, alavi hospital
City
Ardabil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3326 1714
Fax
Email
gamissijinous@gmail.com

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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals and after the publication of the article
When the data will become available and for how long
Access period starts 12 months after the article are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
All documents and analyzes can be used only as a result of research after identifying individuals.
From where data/document is obtainable
Dr. nooshin mobaraki_asl, Ardabil University of Medical Sciences, alavi hospital, n.mobaraki@aruma.ac.ir Jinous Gamissi, Ardabil University of Medical Sciences, alavi hospital, gamissijinous@gmail.com
What processes are involved for a request to access data/document
After receiving the email, depending on the volume and type of data request will be sent
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