This is a clinical trial study that compares the effects of Anethum graveolens extract and mefenamic acid on pain after delivery. Sample size are containing 108 patients in two groups, the Anethum graveolens extract as intervention and mefenamic acid as the control group. Inclusion criteria: people who have normal vaginal delivery; people who are multipar; term pregnancy; Cephalic presentation; single fetus; people who have after delivery pain; infant weight range is 2500-4000 g. When patients are arguing about moderate or high levels of pain, first, their pain measured with a ruler and randomly use mefenamic acid capsule or Anethum graveolens extract. Pain before and half hour after each intervention is measured with a ruler. Patients are asked about how many minutes does it take pain killer affect after each intervention. During this time, any abnormal bleeding in both groups are measured based on the number of pads used. If there was any necessity, next procedures will be done. In addition, during the research, if the pain not being controlled, using of any painkiller drugs for mothers are permitted.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015070623102N1
Registration date:2015-07-27, 1394/05/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-27, 1394/05/05
Registrant information
Name
Fatemeh Kheiriyat
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 5283 9421
Email address
f.kheiriyat@gmail.com
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-07-20, 1394/04/29
Expected recruitment end date
2015-10-21, 1394/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Anethum graveolens extract and mefenamic acid on after pain
Public title
The effect of Anethum graveolens extract on after pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: people who have normal vaginal delivery; people who are multipar; people who have term pregnancy; people who have after delivery pain; infant weight range is 2500-4000 g; Possible drug orally. Exclusion criteria: if drugs could not sedate the mother and other interventions was necessary; Dystocia and prolonged labor; those have history of c/s or other abdominal surgery; those have any history of postpartum hemorrhage; those have history underlying disease.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahwaz Ethics committee of Jundishapur University of Medical Sciences, Ahwaz, Iran
Street address
Ahwaz Jundishapur University of Medical Sciences, Golestan street, Ahwaz, Iran
City
Ahwaz
Postal code
Approval date
2015-06-20, 1394/03/30
Ethics committee reference number
IR.AJUMS.REC.1394.187
Health conditions studied
1
Description of health condition studied
after pain
ICD-10 code
z39
ICD-10 code description
Postpartum care and examination
Primary outcomes
1
Description
The duration of pain
Timepoint
Four times in one day
Method of measurement
Per minute
2
Description
The frequency of abnormal bleeding
Timepoint
Four times in one day
Method of measurement
The number of pads used
3
Description
The intensity of after pain
Timepoint
Four times in one day
Method of measurement
Visual pain scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 2, Mefenamic Acid, oral Capsule, 250 mg, per 6 hours for 24 hours, brand name: Ponstan, Manufacturer: Razak
Category
Treatment - Drugs
2
Description
intervention1: 1.5 mg Anethum graveolens extract per kg of body weight of within 24 hours, every 6 hours to 4 dose, manufacturer Baryj Essence
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital in Ahwaz
Full name of responsible person
Fatemeh Kheiriyat, Master student
Street address
Razi Hospital, Saat plaza, Amaniyeh
City
Ahwaz
2
Recruitment center
Name of recruitment center
Imam Khomeini Hospital in Ahwaz
Full name of responsible person
Fatemeh Kheiriyat
Street address
Imam Khomeini Hospital in Ahwaz, Sharifzadeh street
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahwaz JundiShapur University of Medical Sciences
Full name of responsible person
Dr.Seyed Ahmad Hosseini
Street address
Opposite the central building, Ahwaz Jundishapur University of Medical Sciences, Vice Chancellor for Research, Ahwaz University of Medical Sciences
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahwaz JundiShapur 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
Ahwaz Jundishapur University of Medical Sciences, Ahwaz, Iran
Full name of responsible person
Fatemeh Kheiriyat
Position
Master Student Midwifery
Other areas of specialty/work
Street address
Ahwaz Jundishapur University of Medical Sciences, Golestan street, Ahwaz, Iran
City
Ahwaz
Postal code
6361865834
Phone
+98 61 5283 9421
Fax
Email
F.Kheiriyat@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Mitra Tadayon Najafabadi
Position
Master of Midwifery
Other areas of specialty/work
Street address
Ahwaz Jundishapur University of Medical Sciences, Golestan street, Ahwaz, Iran
City
Ahwaz
Postal code
Phone
+98 61 5283 9421
Fax
Email
Mitratadayon@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Fatemeh Kheiriyat
Position
Midwifery Master student
Other areas of specialty/work
Street address
Ahwaz Jundishapur University of Medical Sciences, Golestan street
City
Ahwaz
Postal code
Phone
+98 61 5283 9421
Fax
Email
F.Kheiriyat@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)