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Comparison of the Effect of Chamomila Matricaria and Mefnamic Acid capsules on post partum pain and hemorrhage

Protocol summary

Summary
This is a double-blind clinical trial study that compares the effects of chamomila matricaria and mefenamic acid on post partum pain and hemorrhage .Sample size are70 multiparous women that delivery in the Ommolbanin hospital in Mashhad city. The samples are divided randomaly into two groups A and B. Inclusion criteria: normal vaginal delivery,live birth, gestational age:37 to 42, multiparity, neonatal weight is 2500-4000 gr, singleton,having moderate or sever afterpain based on a visual scale . bleeding measure after completion of Third labour until the intervention time and 6 hours after the intervention per hour with weight of pad and cotton sheet. Using the visual analogue scale, after pain determine during two to four hours after delivery if their pain is moderate or sever they are taking a chamomila capsual 1000mg or a mefnamic acid capsual 250mg. Intensity of pain and bleeding are measured and Recorded before Medication and one, two, three, four, five, six after medication .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015050322053N1
Registration date: 2015-06-25, 1394/04/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-06-25, 1394/04/04
Registrant information
Name
Maliheh Rezvanifard
Name of organization / entity
Mashhad University of Medical Sciencess
Country
Iran (Islamic Republic of)
Phone
+98 51 3840 2926
Email address
rezvanifardm911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2015-01-12, 1393/10/22
Expected recruitment end date
2015-06-12, 1394/03/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Chamomila Matricaria and Mefnamic Acid capsules on post partum pain and hemorrhage
Public title
Comparison of the Effect of Chamomila Matricaria and Mefnamic Acid capsules on post partum pain and hemorrhage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age :18- 35 years, normal vaginal delivery,live birth, gestational age:37 to 42, multiyparity, cephalic presentation, neonatal weight is 2500-4000 gr, singleton,having moderate or sever afterpain based on a visual scale, no consumption of benzodiazepine , barbiturates, narcotics, alcohol, aspirin, warfarin and heparin 11, no sensitive to Chamomila, no history of medical illness, no cesariansection history, no sever bleeding, No rupture of the cervix and uterus, no history of postpartum hemorreage, no addiction of mother to drugs and alcohol, no high risk pregnancy, no rupture of membranes more than 12 hours. Exclusion criteria: mother's unwillingness to continue to participate In study, sever bleeding
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
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
Mashhad University of Medical Sciences
Street address
Doctora intersection. Ibn Sina Street
City
mashhad
Postal code
Approval date
2014-11-18, 1393/08/27
Ethics committee reference number
930272

Health conditions studied

1

Description of health condition studied
after pain
ICD-10 code
Z39
ICD-10 code description
Postpartum care and examination

2

Description of health condition studied
post partum hemorreage
ICD-10 code
O72.1
ICD-10 code description
Haemorrhage following delivery of placenta

Primary outcomes

1

Description
The intensity of after pain
Timepoint
Two to four hours after delivery Up to six hours of intervention per hour
Method of measurement
visual analog scale

2

Description
postpartum hemorreage
Timepoint
after completion of the third stage of labor uo to Six hours after the intervention per hour
Method of measurement
weight pad and cotton sheets

Secondary outcomes

empty

Intervention groups

1

Description
Intervention 1: An Chamomila Matricaria capsules 1000mg 2 to 4 hours after birth
Category
Treatment - Drugs

2

Description
Intervention 2: Mefenamic Acid capsule 250mg 2 to 4 hours after birth
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Omolbanin Hospital
Full name of responsible person
Maliheh Rezvanifard
Street address
Mashhad University of Medical Sciences
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen tafaghodiy
Street address
University Avenu, Central Organization of Mashhad University of Medical Sciences
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Maliheh Rezvanifard
Position
Graduate Student Midwives
Other areas of specialty/work
Street address
Doctora intersection, Ibn Sina Street
City
Mashhad
Postal code
Phone
+98 518591511
Fax
Email
Rezvanifardm911@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Abedian
Position
Master of Midwifery
Other areas of specialty/work
Street address
Doctoora intersection, Ibn Sina Street
City
Mashhad
Postal code
Phone
+98 518591511
Fax
Email
Abedianz@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maliheh
Position
Graduate Student Midwives
Other areas of specialty/work
Street address
Doctora intersection, Ibn Sina Street
City
Mashhad
Postal code
Phone
+98 518591511
Fax
Email
Rezvanifardm911@mums.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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