Protocol summary

Summary
Cesarean section, one of the most common surgeries, has complications such as flatulence, nausea, belching and flatus. we used cumin and supermint in the current study. The study population comprised all pregnant women undergoing cesarean section with the following inclusion criteria: no history of gastrointestinal diseases, no adhesion observed during surgery….). The sample size was 83 people. Interventions began the day after the surgery simultaneous with drinking tea and before having a meal for 3 times with a 20-min interval. Each group (1, 2 and 3) that were randomly selected received 40 drops of cumin and supermint in 30 ml of water and 30 ml of syrup respectively. Twenty minutes and 120 minutes after the first intervention, the questionnaire was completed. In fact, the third group (milk of magnesia) received the routine medication of the hospital and were considered the control group. For each medicine group, the intended medicine was poured into graduated containers by an assistant and the researcher was blinded to the contents and gave the patients the form of double-blind trial. All participants in the study were matched in terms of cesarean section period and normal BMI (26-19). ). After taking the first dose of the medicine, at the end of 20 min the questionnaire was filled out and questions about all variables (nausea, vomiting, etc.) were asked of the patients step by step and were marked on the questionnaire.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014062918280N1
Registration date: 2014-08-15, 1393/05/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-08-15, 1393/05/24
Registrant information
Name
Maryam Tofighi Niaki
Name of organization / entity
Islamic Azad University Sari Brabch
Country
Iran (Islamic Republic of)
Phone
+98 11 3303 3857
Email address
maryamtofighi@iausari.ac.ir
Recruitment status
Recruitment complete
Funding source
Chancellor for research Of Islamic Azad University Sari Branch
Expected recruitment start date
2012-08-21, 1391/05/31
Expected recruitment end date
2014-01-20, 1392/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Cumin and Supermint (Peppermint Oil) and Milk of Magnesia on Gastrointestinal Complications after Caesarean Section
Public title
The effect of drugs on gastrointestinal complications after caesarean
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: uneventful transects ; Singleton infant;Term pregnancy(38-42); No blood transfusion;Second repeat cesarean;normal BMI(19-26); With general anesthesia. Exclusion Criteria:History of surgical adhesions;fever;Gastrointestinal disorders (colitis, Cron,IBS);Gastritis drugs;Spinal anesthesia
Age
From 22 years old to 32 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 83
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
Ethics Committee of The Islamic Azad University Sari Branch
Street address
Phyrozkandeh ,Darya Street, Sari
City
Sari
Postal code
4816119318
Approval date
2012-05-07, 1391/02/18
Ethics committee reference number
03

Health conditions studied

1

Description of health condition studied
Pregnancy, childbirth and the puerperium
ICD-10 code
O85,O92
ICD-10 code description
Complications predominantly related to the puerperium

Primary outcomes

1

Description
Defecation
Timepoint
every 20 min and 120 min after the end of the firrst intervention
Method of measurement
Questionnaire to yes/No

2

Description
Bloating
Timepoint
every 20 min and 120 min after the end of the firrst intervention
Method of measurement
Questionnaire to yes/No

Secondary outcomes

1

Description
Nausea
Timepoint
every 20 min and 120 min after the end of the first intervention
Method of measurement
Questionnaire to yes/no

2

Description
Heart burn
Timepoint
every 20 min and 120 min after the end of the first intervention
Method of measurement
Questionnaire to yes/no

3

Description
Belching
Timepoint
every 20 min and 120 min after the end of the first intervention
Method of measurement
Questionnaire to yes/no

4

Description
Flatus
Timepoint
every 20 min and 120 min after the end of the first intervention
Method of measurement
Questionnaire to yes/no

5

Description
vomiting
Timepoint
every 20 min and 120 min after the end of the first intervention
Method of measurement
Questionnaire to yes/no

Intervention groups

1

Description
The intervention group: cumin: 40 drops in 30 cc municipal tap water 3 times with 20-minute intervals
Category
Treatment - Drugs

2

Description
The intervention group: peppermint essential oil : 40 drops in 30 cc municipal tap water 3 times with 20-minute intervals
Category
Treatment - Drugs

3

Description
The Control group: milk of magnesia: 30 cc ، 3 times with 20-minute intervals
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Tahereh Asadi
Street address
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The Islamic Azad University Sari Branch
Full name of responsible person
Hamed Samadi
Street address
Phyrozkandeh ,Darya Street
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Islamic Azad University Sari Branch
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
The Islamic Azad University Sari Branch
Full name of responsible person
Maryam Tofighi Niaki
Position
Msc/Faculty Member
Other areas of specialty/work
Street address
Phyrozkandeh, Darya Street
City
Sari
Postal code
4816119318
Phone
+98 11 3303 3857
Fax
Email
maryamtofighi@iausari.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University Sari Branch
Full name of responsible person
Maryam Tofighi Niaki
Position
Msc/Faculty Member
Other areas of specialty/work
Street address
Phyrozkandeh ,Darya Street
City
Sari
Postal code
Phone
+98 11 3303 3857
Fax
Email
maryamtofighi@iausari.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University Sari Branch
Full name of responsible person
Maryam Tofighi Niaki
Position
Msc/Faculty Member
Other areas of specialty/work
Street address
Phyrozkandeh, Darya Street
City
Sari
Postal code
Phone
00
Fax
Email
maryamtofighi@iausari.ac.ir
Web page address

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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