Effect of hydro-alcoholic extract of Capsella bursa Pastoris on postpartum pain
Design
Randomized triple blinded clinical trial with parallel groups
Settings and conduct
In a randomized, triple-blind, randomized clinical trial women who fulfill the inclusion criteria and reported postpartum pain score more than four will be enrolled in study. The intervention group will receive mefenamic acid capsule 50 mg, every 6 hours for a maximum of 4 doses for 24 hours plus 10 sublingual drops of hydroalcoholic extract of Capsella bursa Pastoris containing 500 mg of the extract. Control group will receive mefenamic acid capsule 250 mg, every 6 hours for a maximum of 4 doses for 24 hours plus 10 drops placebo (distilled water) sublingually.
Participants/Inclusion and exclusion criteria
Mothers of normal vaginal delivery and gestational age of 42-37 weeks, with a single live infant who borned with cephalic presentation, weight of 2500-4000gr will be enrolled in study. Mothers with prolonged labor or assisted or analgesic delivery and severe bleeding, drug addiction, or with systemic disease, as well as patients with grade 3 and 4 perineal rupture will be excluded from the study.
Intervention groups
Intervention group (sublingual drops of hydro-alcoholic extract of Capsella bursa Pastoris and mefenamic acid capsule 250mg)
Control group (recipient of sublingual placebo drop and mefenamic acid capsule 250mg)
Main outcome variables
Severity of postpartum pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191002044948N1
Registration date:2020-02-04, 1398/11/15
Registration timing:retrospective
Last update:2020-02-04, 1398/11/15
Update count:0
Registration date
2020-02-04, 1398/11/15
Registrant information
Name
Maryam Keshavarzinejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3522 5663
Email address
maryam.keshavarzinejad1369@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-06, 1398/04/15
Expected recruitment end date
2019-12-06, 1398/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of hydro-alcoholic extract of Capsella bursa Pastoris on postpartum pain
Public title
Effect of hydro-alcoholic extract of Capsella bursa Pastoris on postpartum pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Normal Delivery
The gestational age is 37-42 weeks
Live single baby with cephalic presentation
The fetal weight is 2500-4000
Moderate or severe pain based on Pain Ruler
Exclusion criteria:
Any problems that require emergency action such as maternal bleeding
Severe bleeding
Difficult and prolonged childbirth and use of tools
analgesics for childbirth
Drug addiction or psychotropic drugs
Systemic disease
Perineal ruptures grade 3 and 4
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization perform by an independent trial center. If a patient fulfill the inclusion criteria and has signs informed consent, the researcher contacts the trial center. A quadratic permutation block method used. Subjects in blocks 1, 3 and 5 entered into the control group and subjects in blocks 2, 4 and 6 entered into the intervention group and simple randomized table used to select blocks. To assign patients to study groups the random assignment sheet will be used by trained personnel.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The placebo is similar to the drug regarding shape of container, color, and volume and the researcher and patient will not aware of the type of extract or placebo. The outcome assessor do not know the types of the patient's intervention and only has the patient's specific code. In addition, statistician will not aware of the study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
University Square.,Nilufar Ave.,Maryam Street., Damqan Town.,Plaque21
City
Damqan
Province
Semnan
Postal code
3671639846
Approval date
2017-07-01, 1396/04/10
Ethics committee reference number
IRSBMU.PHNM.1396.746
Health conditions studied
1
Description of health condition studied
postpartum pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Severity of pain
Timepoint
Every 1 hour up to six hours after intervention and then every 6 hours up to 24 hours after intervention
Method of measurement
Pain Ruler
Secondary outcomes
1
Description
Duration of pain
Timepoint
One hour after taking the drug
Method of measurement
In hours and minutes
Intervention groups
1
Description
The intervention group received mefenamic acid capsule 250 mg, every 6 hours for a maximum of 4 doses for 24 hours plus 10 sublingual drops of hydroalcoholic extract of Capsella bursa Pastoris containing 500 mg of the extract.
Category
Treatment - Drugs
2
Description
Control group received mefenamic acid capsule 250 mg, every 6 hours for a maximum of 4 doses for 24 hours plus 10 drops placebo (distilled water) sublingually.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat Hospital
Full name of responsible person
Maryam keshavarzinejad
Street address
University Square.,Nilufar Ave.,Maryam Street., Damqan Town.,Plaque21
City
Damqan
Province
Semnan
Postal code
3671639846
Phone
+98 23 3522 5663
Email
maryam.keshavarzinejad1369@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Research Assistant, School of Nursing and Midwifery
Street address
Vice-Chancellor for Research, Midwifery Nursing and Midwifery, Third floor, Vice chancellor for research, Shahid Rajaee Heart Hospital
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2517
Fax
+98 21 8820 2517
Email
n_kariman@yahoo.com
Web page address
https://www.sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Nour sadat Kariman
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Vice-Chancellor for Research, Midwifery Nursing and Midwifery, Third floor, Vice chancellor for research, Shahid Rajaee Heart Hospital
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2516
Fax
+98 21 8820 2516
Email
n_kariman@yahoo.com
Web page address
https://www.sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Noursadat Kariman
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Vice chancellor for research, Third floor, Vice chancellor for research, Nursing and Midwifery Faculty, Valiasr Ave.
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8820 2516
Fax
+98 21 8820 2516
Email
n_kariman@yahoo.com
Web page address
https://www.sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam keshavarzinejad
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
University Square.,Nilufar Ave.,Maryam Street., Damqan Town.,Plaque21
City
Damqan
Province
Semnan
Postal code
3671639846
Phone
+98 23 3522 5663
Email
maryam.keshavarzinejad1369@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data can be shared after unidentifiable people
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
researchers
Under which criteria data/document could be used
Correspondence
From where data/document is obtainable
Mailing address to researcher
What processes are involved for a request to access data/document