Comparative study of the effect of Fennel capsules and Ibuprofen on postpartum after pain in multiparous women admitted in postpartum ward of Sanandaj Beasat hospital
The purpose of the study is investigating the effect of the fennel capsules and ibuprofen tablets on the amount of labor's after pain in multiparous women admitted in postpartum ward of the Besat Hospital in Sanandaj. The kind of the study is single blind clinical trail, this means that the number of 70 patients with vaginal delivery who have got the number of 4 or more for their pain -in that case of not having an instrumental delivery, not having the tear of 3 or 4 degrees and unsatisfactorily from the cooperation -will be studied. we randomly will putting up the samples on two groups means 35 persons who will be studied with fennel capsules or ibuprofen tablets on each one of groups. demographic characteristics and obstetric history of the patients will be recorded on the information forms, then we will measure the intensity of pain every time before, after and 1 hour after the intervention, we do that for 4 times with the duration of every 6 times until 24 hours using VAS (Vaginal Analogue Scale), then we will record it in the information forms .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016100930238N1
Registration date:2017-02-10, 1395/11/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-10, 1395/11/22
Registrant information
Name
Parya Foroughi
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 3377 8405
Email address
p.foroughi@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2017-01-24, 1395/11/05
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of Fennel capsules and Ibuprofen on postpartum after pain in multiparous women admitted in postpartum ward of Sanandaj Beasat hospital
Public title
Fennel effect on pain after childbirth
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: vaginal delivery; The term gestational age (40-37 weeks); live births; singleton; fetal weight 4000-2500 g;The lack of specific diseases such as ulcers or gastrointestinal bleeding or known cardiovascular disease; higher pain score of 4 and Exclusion criteria: severe bleeding after childbirth; Perform evacuating corpus luteum or manual removal of placenta; Use the tools (vacuum, forceps),having perineal tear grade 3 and 4; The labor long and hard;sensitivity to fennel; In case of dissatisfaction with the continued cooperation in the study for any reason and at any stage of the research will be withdrawn.
Age
From 17 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Kurdistan University of Medical Sciences
Street address
Ground Floorof Kurdistan University of Medical Sciences,Paasdaaran St Sanandaj,Kurdistan,Iran
City
Sanandaj
Postal code
6617713446
Approval date
2016-06-13, 1395/03/24
Ethics committee reference number
MUK.REC.1395.85
Health conditions studied
1
Description of health condition studied
post partom after pain
ICD-10 code
O00,O99,O8
ICD-10 code description
Pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
post partom after pains
Timepoint
Every 6 hours up to 24 hours before and hour after intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group fennel capsules 30 mg orally every 6 hours for 24 hours after delivery
Category
Treatment - Drugs
2
Description
In the control group Ibuprofen 200 mg orally every 6 hours for 24 hours after delivery
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Leila Hasheminasab
Street address
Department for Midwifery, Kurdistan University of Medical Sciences, Sanandaj,Kurdistan, Iran
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kurdistan University Of Medical Sciences
Full name of responsible person
Farzin Rezaei
Street address
Kurdistan University Of Medical Sciences
City
Sanandaj
Grant name
1395.85
Grant code / Reference number
25000000
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdistan 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
Kurdistan University of Medical Sciences
Full name of responsible person
Leila Hasheminasab
Position
Master of Midwifery
Other areas of specialty/work
Street address
Department for Midwifery, Kurdistan University of Medical Sciences, Sanandaj,Kurdistan, Iran
City
Sanandaj
Postal code
Phone
+98 8709183710634
Fax
Email
hasheminasab.l.2014@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
kurdistan univercity of medical sciens
Full name of responsible person
Leila Hasheminasab
Position
Master of Midwifery
Other areas of specialty/work
Street address
Department for Midwifery, Kurdistan University of Medical Sciences, Sanandaj,Kurdistan, Iran
City
Sanadaj
Postal code
66177-13446
Phone
+98 918 371 0634
Fax
Email
hasheminasab.l.2014@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Parya Foroughi
Position
Experimental diploma
Other areas of specialty/work
Street address
Kurdistan University of Medical Sciences, Sanandaj,Kurdistan, Iran
City
Sanandaj
Postal code
6617878141
Phone
+98 87 3377 8405
Fax
Email
foroghip@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)