The aim of this study was to determine the effect of oral Bromelain on perineal pain and wound healing in primiparus women. In this double-blind clinical trial, 100 women with mediolateral episiotomy randomly received Bromelain, 100 mg (one tablet), starting at 2 hours after delivery, three times daily for six days or placebo. Episiotomy pain was measured by VAS scale at the first 24 hours, 3th, 7th, and 14th day and wound healing was measured by REEDA scale on 3th, 7th, and 14th day after delivery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810112952N1
Registration date:2010-02-27, 1388/12/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-02-27, 1388/12/08
Registrant information
Name
Samira Golozar
Name of organization / entity
Ahwaz Jondishapoor University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 935 568 6685
Email address
golezar@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jondishapur University of Medical Sciences, Ahwaz
Expected recruitment start date
2009-06-05, 1388/03/15
Expected recruitment end date
2009-10-22, 1388/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of oral Bromelain (pineapple) on episiotomy pain and wound healing in primiparus women
Public title
The effect of Bromelain on episiotomy pain and wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 18 to 35 years, Gestational age between 37 to 42 weeks, single pregnancy, cephalic presentation, Iranian nationality, residence in Ahvaz, Normal vaginal delivery, newborn Weight between 2500 to 4000 grams, medio-lateral episiotomy with 4-3 cm length, Education level at least the fifth grade, body mass index: 19/6-26, cervical dilation 3-5 cm
Exclusion criteria: Diseases affecting wound healing (diabetes, kidney disease, anemia, liver diseases, cystocele or anxiety disorders), smoking and drug abuse, consumption of drugs affecting wound healing (glucocorticoids, anti-coagulatives, immune system suppressants, antibiotics or chemotherapy agents), abortion, premature rupture of membranes, having symptoms indicative of infection, anemia, rectum and vulva lesions, abnormal bleeding after childbirth, hematoma in the perineal operation, newborn anomaly, dead baby, abnormal first, second or third delivery stage
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:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahwaz Jondishapoor University of Medical Sciences
Street address
Ahwaz Jondishapoor University of Medical Sciences, Golestan Blvd.
City
Ahwaz
Postal code
Approval date
2009-07-11, 1388/04/20
Ethics committee reference number
3/8/20/1946
Health conditions studied
1
Description of health condition studied
Episiotomy
ICD-10 code
O90
ICD-10 code description
Complications of the puerperium, not elsewhere classified
Primary outcomes
1
Description
Pain
Timepoint
2 hrs after delivery, 24 hrs after delivery, 1 hr after consumption of initial dose, 3th, 7th, and 14th day after delivery
Method of measurement
VAS scale
Secondary outcomes
1
Description
wound healing
Timepoint
3th, 7th, and 14th day after delivery
Method of measurement
REEDA scale
Intervention groups
1
Description
Bromelain, 100mg (one tablet), starting from 2 hrs after delivery, three tims daily for six days
Category
Treatment - Drugs
2
Description
Placebo, one tablet, from 2 hrs after delivery, three times daily for six days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Ms Dobahri Zadeh
Street address
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research center of Jondishapur University of Medical Sciences
Full name of responsible person
Ms Jaderi
Street address
Jondishapur University of Medical Sciences, Golestan Blvd.
City
Ahwaz
Grant name
Grant code / Reference number
u-88146
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research center of Jondishapur 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 Jondishapoor University of Medical Sciences
Full name of responsible person
Samira Golozar
Position
MSc of midwifery
Other areas of specialty/work
Street address
Tuyserkan Azad University, Hayogh nabi Square.
City
Tuyserkan
Postal code
Phone
+98 83 7222 4977
Fax
Email
golezar80@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz Jondishapoor University of Medical Sciences
Full name of responsible person
Samira Golozar
Position
MSc of midwifery
Other areas of specialty/work
Street address
Tuysekan Azad University, Hayogh nabi Square.
City
Tuyserkan
Postal code
Phone
Fax
Email
golezar@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz Jondishapoor University of Medical Sciences
Full name of responsible person
Samira Golozar
Position
MSc of midwifery
Other areas of specialty/work
Street address
Hayogh nabi square, Tuyserkan Azad University
City
Tuyserkan
Postal code
Phone
+98 83 7222 4977
Fax
Email
golezar80@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)