This is a double-blind clinical trial study that compares the effects of ginger and mefenamic acid on pain after delivery in multiparous women. Sample size are containing 122 patients in two groups, the ginger as intervention and mefenamic acid as the control group. Inclusion criteria: 1-people who have normal vaginal delivery; 2-people who are multipar; 3-gestational age:37 to 42 weeks; 4-people who have after delivery pain; 5- people who are not unread; 6-infant weight range is 2500-4000 g; 7-women's body mass index is 19.8-29. When patients are arguing about moderate or high levels of pain, first, their pain measured with a ruler and randomly use mefenamic acid or ginger capsule. 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 approximation by observing the value. 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:IRCT2013052613475N1
Registration date:2013-07-20, 1392/04/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-20, 1392/04/29
Registrant information
Name
Somayeh Poormaleky
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 65 2242 8788
Email address
poormaleky.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2013-05-10, 1392/02/20
Expected recruitment end date
2013-08-11, 1392/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison effect of ginger and mefenamic acid on after delivery pain in multiparous women
Public title
The effect of ginger on after delivery pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-people who have normal vaginal delivery; 2-people who are multipar; 3-gestational age:37 to 42 weeks; 4-people who have after delivery pain; 5- people who are not unread; 6-infant weight range is 2500-4000 g; 7-women's body mass index is 19.8-29; 8-Mother should not use another palliative procedure; 9- people who Have not hard labor; 10-Those people who are not addict; 11-people who have not history of allergy to ginger or other plants; 12-those have not history of c/s or other abdominal surgery; 13-those have not any history of postpartum hemorrhage;
14-No underlying disease.
Exclusion criteria: if drugs could not sedate the mother and other interventions was necessary.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
122
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
For a random sampling, mothers are randomly selected, divided by code ginger and mefenamic acid into two groups. Code selection is based on random selection of numbers, from bag with 61 ginger and 61 mefenamic acid, and the code are A and B have been determined. For the drug selection, also there are 61 bags containing 4 capsules of mefenamic acid and 61 bags containing 4 capsules of Zintoma are prepared and code A and code B are issued on them. For that reason for researchers to not to aware of prescribed medications, drugs are encoded by a midwife colleagues. Packet selection based on the code on the form is optional.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Ethics committee of Jundishapur University of Medical Sciences,Ahvaz,Iran
Street address
Golestan Street-Ahvaz Jundishapur University of Medical Sciences,Ahvaz,Iran
City
Ahvaz
Postal code
61357-15794
Approval date
2013-05-04, 1392/02/14
Ethics committee reference number
eth-737
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 intensity of after pain
Timepoint
Before intervention & 4 times after intervention.
Method of measurement
Visual pain scale
2
Description
The duration of pain
Timepoint
After intervention
Method of measurement
Per minute
3
Description
The frequency of abnormal bleeding
Timepoint
To 24 hours after delivery
Method of measurement
According to national guidelines
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1:Ginger, Capsule 250 mg oral- per 6 hours for 24hours, brand name:Zintoma, Manufacturer:Goldaru
Category
Treatment - Drugs
2
Description
Intervention 2, 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
Mashahr Hospital
Full name of responsible person
Somayeh Poormaleky
Street address
City
Mashahr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Full name of responsible person
Mostafa Feghhi
Street address
Golestan street, Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
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, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Somayeh Poormaleky
Position
Master student
Other areas of specialty/work
Street address
Golestan Street-Ahvaz Jundishapur University of Medical Sciences, Ahvaz,Iran
City
Ahvaz
Postal code
Phone
+98 65 2242 8788
Fax
Email
poormaleky.s@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur university of Medical Sciences
Full name of responsible person
Somayeh Poormaleky
Position
Master student
Other areas of specialty/work
Street address
Golestan Street,Ahvaz Jundishapur university of Medical Sciences,Ahvaz,Iran
City
Ahvaz
Postal code
Phone
+98 933 342 4185
Fax
Email
poormaleky.s@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Somayeh Poormaleky
Position
Master student
Other areas of specialty/work
Street address
Golestan Street, Ahvaz Jundishapur University of Medical Sciences,Avaz,Iran
City
Ahvaz
Postal code
Phone
00
Fax
Email
poormaleky.s@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)