After pain is a complication occurring during postpartum, which requires an appropriate analgesic to relieve the pain. This is a single-blind clinical trial study that compares the effects of fennel and mefenamic acid on post partum after pain in women. Sample size is containing 90 postpartum women in two groups, the fennel as case and Mefenamic acid as the control group. Inclusion criteria: normal vaginal delivery;gestational age:37 to 42 weeks; post partum women with after pain;literate women; woman's with infant weight range about 2500-4000 g.
When women complains of moderate or high levels of pain, first, their pain will measure with a ruler and randomly use Mefenamic acid or fennel capsules for them.then before and 1 hour after each intervention Pain will measure with a ruler. In addition, during the research, if the pain continues despite of these drugs , using of any sedative drugs for mothers are permitted.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014020515338N2
Registration date:2014-05-20, 1393/02/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-05-20, 1393/02/30
Registrant information
Name
Shahnaz Golian Tehrani
Name of organization / entity
Nursing and Midwifery faculity
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 4090
Email address
golian@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Sponsor 1 : Tehran University of Medical Science research
Expected recruitment start date
2014-06-05, 1393/03/15
Expected recruitment end date
2014-08-06, 1393/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of Fennel and Mefenamic Acid effects on post partum after pain
Public title
Evaluation of fennel effect on post partum after pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- normal vaginal delivery; 2-gestational age:37 to 42 weeks; 3-post partum women with after pain; 4- literate women; 5- woman's with infant weight range about 2500-4000 g; 6- women without difficult or prolonged labor;7-No addiction; 8- No herbal allergy history; 9- No cesarean section and abdominal surgery history; 10- No postpartum hemorrhage history; 11- No underlying disease. Exclusion criteria: if drugs could not sedate the mother and other interventions was necessary; history of ulcers or gastrointestinal bleeding.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz Boulevard,Ghods St.Central Organization of University,The Sixth Floor
City
Tehran
Postal code
Approval date
2014-03-15, 1392/12/24
Ethics committee reference number
92/د/3021/130
Health conditions studied
1
Description of health condition studied
postpartum after pain
ICD-10 code
Z39
ICD-10 code description
Postpartum care and examination
Primary outcomes
1
Description
The intensity of after pain
Timepoint
Before intervention &and1 hour after intervention
Method of measurement
Visual pain scale
Secondary outcomes
1
Description
side effect
Timepoint
After the last dose
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group1: Fennel, capsule30mg oral- per 6 hours for 24hours, brand name : Fennelin Manufacturer :barijessence
Category
Treatment - Drugs
2
Description
Mefenamic Acid, oral Capsule, 250 mg, per 6 hours for 24hours, brand name: Ponstan , Manufacturer:Razak
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Beharlu Hospital
Full name of responsible person
ashraf soltani moghaddam
Street address
Rahahan Square;Behdari; Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Science research
Full name of responsible person
Dr Fotoohi Akbar
Street address
Keshavarz BLD, Ghods street, Central building of Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Science research
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
Tehran University of Medical Science
Full name of responsible person
Shahnaz g\Golian tehrani
Position
Faculty member,Master of Midwifery
Other areas of specialty/work
Street address
Tohid Square-faculty of Nursing & Midwifery tehran university of medical science Tehran
City
Tehran
Postal code
Phone
+98 21 6693 7120
Fax
+98 21 6690 4252
Email
Golian2005@yahoo.comgolian@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Golian tehrani Shahnaz
Position
Faculty member,Master of Midwifery
Other areas of specialty/work
Street address
Tohid Square-faculty of Nursing & Midwifery tehran university of medical science
City
Tehran
Postal code
Phone
+98 21 6693 7120
Fax
+98 21 6690 4252
Email
golian@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Soltani moghadam Ashraf
Position
Graduate student Midwifery
Other areas of specialty/work
Street address
Tohid Square-faculty of Nursing & Midwifery tehran university of medical science
City
Tehran
Postal code
Phone
+98 21 6693 7120
Fax
+98 21 6690 4252
Email
ashraf_soltani_88@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)