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Study on the effect of wheat germ on postpartum after pain in women that referred to Mahdieh hospital in Tehran

Protocol summary

Study aim
Determination and Comparison of the Effect of wheat germ on postpartum pain
Design
Clinical trials with control group, with parallel groups,double blind, randomized
Settings and conduct
This study is a randomized double blind control trial with Placebo to determine the effect of the wheat germ capsule on the After pain in women referring to Mahdieh Hospital in Tehran in 1397. If samples have a score of 4 or more, they will enter the study.The samples size is 90 person , each group consisting of 45 person.In the case group, two hours after delivery a wheat germ capsule will be given every six hours for 48 hours and in the control group,two hours after delivery a placebo capsule will be given every six hours for 48 hours and one hour after each intervention,the severity of pain is recorded by the pain ruler as a self-report of the samples and if the pain does not relief,Mefnamic Acid capsule will be given and their number will be recorded
Participants/Inclusion and exclusion criteria
Inclusion criteria : Vaginal Delivery,Be Complained of Moderate or Severe pain after Delivery,No Maternal History of Herbal Drugs Allergy,Mother age between 18-35 years ,Deliver a Singleton and Healthy Baby.exclusion criteria:Maternal History of Herbal Drugs Allergy,Maternal History of Chronic Disease,The mother has no history of cesarean section or abdominal or pelvic surgery
Intervention groups
In the case group, two hours after delivery one wheat germ capsule containing 500 mg of powder will be given every six hours for 48 hours and in the control group,two hours after delivery one placebo capsule containing 500 mg of starch will be given every six hours for 48 hours . In both groups, one hour after each intervention, if the pain does not relief,one Mefnamic Acid 250 mg capsule will be given as routine treatment and their number will be recorded.
Main outcome variables
Severity of after pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200211046452N1
Registration date: 2020-04-01, 1399/01/13
Registration timing: retrospective

Last update: 2020-04-01, 1399/01/13
Update count: 0
Registration date
2020-04-01, 1399/01/13
Registrant information
Name
Samira Mehravar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3843 4085
Email address
samiramehravar@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-22, 1398/06/31
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
2019-10-01, 1398/07/09
Actual recruitment end date
2020-01-04, 1398/10/14
Trial completion date
2020-01-06, 1398/10/16
Scientific title
Study on the effect of wheat germ on postpartum after pain in women that referred to Mahdieh hospital in Tehran
Public title
Study on the effect of wheat germ on postpartum after pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Be Iranian Speak Persian Lives with her husband The mother had vaginal delivery Single and healthy baby Gestational age between 37 to 42 weeks The mother has the ability to breast-feed The baby has the ability to breast-feed The mother is satisfied to participate in the study The mother suffers from moderate to severe postpartum pain Delivery whit out devices The mother has no history of cesarean section and abdominal and pelvic surgery Not used of epidural or spinal anesthesia Non-smoking and drug abuse The mother does not have a chronic disease (Hypertension, diabetes, heart disease) Has no history of allergy to wheat germ or other herbal drugs
Exclusion criteria:
Use other herbal or chemical drugs except Mefenamic Acid during the study to relieve pain The mother is suffering from serious complications after delivery (postpartum bleeding, temperature over 39 ° C,blood pressure higher than 140/90) Breast feeding may not be possible for maternal or neonatal reasons The mother is not willing to continue her participation in the study for any reason Sensitivity to wheat germ happen during study
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 90
Actual sample size reached: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method and description of each method: In the custody In randomization unit: Individual Randomization tool: Random number function, opaque and closed envelopes How to create random sequence: Generate random number function in Excel software.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the allocation, the pills will be divided into the opaque A and B packets and numbered by the pharmaceutical consultant .Participant, researcher and outcome checker will be unaware of the type of intervention
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee Of Shahid Beheshti University Of Medical Sciences
Street address
Nursing And Midwifery College Of Shahid Beheshti University Of Medical Sciences, In Front Of Shahid Rajaee Heart Hospital, Niayesh Intersection, Valiasr Avenue
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-02-25, 1397/12/06
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1397.262

Health conditions studied

1

Description of health condition studied
After Pain
ICD-10 code
O85-O92
ICD-10 code description
Complications predominantly related to the puerperium

Primary outcomes

1

Description
Severity of after pain
Timepoint
Before intervention and 1 hour after it
Method of measurement
The Mc Gill Pain Ruler

Secondary outcomes

1

Description
Side effects of the drug
Timepoint
After the intervention
Method of measurement
Side Effects Questionnaire

Intervention groups

1

Description
Intervention group: Two hours after delivery one wheat germ capsule containing 500 mg of powder will be given every six hours for 48 hours and one hour after each intervention, if the pain does not relief,one Mefnamic Acid 250 mg capsule will be given as routine treatment and their number will be recorded.
Category
Treatment - Drugs

2

Description
Control group: Two hours after delivery one placebo capsule containing 500 mg of starch will be given every six hours for 48 hours and one hour after each intervention, if the pain does not relief,one Mefnamic Acid 250 mg capsule will be given as routine treatment and their number will be recorded.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Mahdieh Hospital
Full name of responsible person
Zahra Esmi
Street address
Shishe Gar khaneh Alley, Fadaian Islam Ave, Shoosh Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
11858- 17311
Phone
+98 21 5506 2628
Fax
+98 21 5506 2627
Email
mahdiyeh_hospital@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Nursing And Midwifery College Of Shahid Beheshti University Of Medical Sciences, In Front Of Shahid Rajaee Heart Hospital, NiayeshIntersection, Valiasr Avenue
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2512
Fax
+98 21 8820 2512
Email
padideh.janati@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sedighe Amir Ali Akbari
Position
Educator
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Vali Asr Ave, Niayesh Cross Road, school of Nursing & Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
asa_akbari@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sedighe Amir Ali Akbari
Position
Educator
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Vali Asr Ave, Niayesh Cross Road, school of Nursing & Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
asa_akbari@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sedighe Amir Ali Akbari
Position
Educator
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Vali Asr Ave, Niayesh Cross Road, School of Nursing & Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
asa_akbari@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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