Comparison of the effect of Nigella sativa and Menstrogol ® and Mefenamic acid on postpartum pain in women with after-pain
Design
Triple-blind randomized parallel clinical trial with two intervention and one control groups.
Settings and conduct
This three-blind study will be performed on women who refer to Valiasr Hospital in Birjand for delivery. Individuals will be assigned to three groups of placebo, monstrogel, and black seed if they meet the inclusion criteria with random blocking. Their postpartum pain will be measured with a numerical pain rating scale over 24 hours.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Satisfaction to participate in research
Literacy for reading and writing
Gestational age 37 to 42 weeks
Spontaneous exit of pairs and curtains
Having a moderate to severe back pain score
Having a healthy and single baby
Mother age 15-44 years
Spontaneous vaginal delivery
Iranian
Start and perform breastfeeding successfully
exclusion criteria:
Having serious postpartum complications, not breastfeeding, smoking and using drugs, having medical illness, not taking drugs during labor, having grade 3 and 4 tears, taking painkillers during the last 4 hours, allergy to herbal medicines, Use of epidural and spinal anesthesia during labor, a history of cesarean section and abdominal surgery
Intervention groups
Intervention group 1: One 500 mg capsule of Nigella sativa every 6 hours for 24 hours about 2 hours after delivery
Intervention group 2: One 500 mg capsule of Menstrogol every 6 hours for 24 hours about 2 hours after delivery
Control group: One 250 mg capsule of mefenamic acid every 6 hours for 24 hours about 2 hours after delivery
Main outcome variables
postpartum pain and hemorrhage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200401046914N4
Registration date:2021-10-30, 1400/08/08
Registration timing:prospective
Last update:2021-10-30, 1400/08/08
Update count:0
Registration date
2021-10-30, 1400/08/08
Registrant information
Name
Mahla Salarfard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3243 5793
Email address
salarfard.ma@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-11, 1400/08/20
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of nigella sativa and Menstrogol ® and Mefenamic acid on postpartum pain in women with after-pain
Public title
Black seed and monstrogol and mefenamic acid on postpartum pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Literacy for reading and writing
Gestational age 37 to 42 weeks
Spontaneous exit of pairs and curtains
Having a moderate to severe back pain score
Having a healthy and single baby
Mother age 15-44 years
Spontaneous vaginal delivery
Iranian
Start and perform breastfeeding successfully
Satisfaction to participate in research
Exclusion criteria:
Having serious postpartum complications
Lack of breastfeeding due to maternal and neonatal causes
Smoking and drugs
Having a medical illness
Taking drugs during labor
Having 3rd and 4th degree rupture
Taking painkillers during the last 4 hours
Allergy to herbal medicines
use epidural and spinal anesthesia during labor
Having history of cesarean section and abdominal surgery
Age
From 15 years old to 44 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation is done using three-membered blocks with a ratio of 1: 1: 1 with three members A = black seed capsule, B = monstrogel capsule C = mefenamic acid using block randomization method. To do this, first determine all possible combinations in the blocks (for example, "CBA, ABC, CAB) and then write them on the same pieces of paper and put them in a sealed envelope. The paper is randomly extracted and continues until the sample size is reached.The resulting sequence chain is used to assign participants to the groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The capsule will be given to patients with a completely similar appearance and the form of the drugs will be the same. Therefore, the patient will not know the type of intervention. The data collector will not be aware of the type of intervention. The data analyst will not know the type of intervention. Therefore, the study will be conducted in a three-way blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
committee of Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Moalem Street
City
Birjand
Province
South Khorasan
Postal code
9716813456
Approval date
2020-09-28, 1399/07/07
Ethics committee reference number
IR.BUMS.REC.1399.286
Health conditions studied
1
Description of health condition studied
postpartum pain
ICD-10 code
Z39
ICD-10 code description
Encounter for maternal postpartum care and examination
Primary outcomes
1
Description
Intensity postpartum after-pain
Timepoint
Before and one hour after the first intervention, before and one hour after the second intervention, before and one hour after the third intervention, before and one hour after the fourth intervention.
Method of measurement
Numeric pain Rating scale
2
Description
Postpartum hemorrhage
Timepoint
Before and after the intervention
Method of measurement
Higam bleeding measuring instrument
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One 500 mg capsule of Nigella sativa every 6 hours for 24 hours about 2 hours after delivery
Category
Treatment - Other
2
Description
Intervention group: One 500 mg capsule of Menstrogol every 6 hours for 24 hours about 2 hours after delivery
Category
Treatment - Other
3
Description
Control group: One 250 mg capsule of mefenamic acid every 6 hours for 24 hours about 2 hours after delivery
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital of Birjand
Full name of responsible person
Nahid Barati
Street address
Valiasr Hospital, Ghaffari St. Birjand City.
City
Birjand
Province
South Khorasan
Postal code
9717964151
Phone
+98 56 3162 2001
Email
valiasr@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemi
Street address
Deputy of Research and Technology, Third Floor of Education and Research Building ,University of Medical Sciences, Birjand
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Nahid Barati
Position
Midwife
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Valiasr Hospital, Ghaffari St. Birjand City.
City
Birjand
Province
South Khorasan
Postal code
9716813448
Phone
+98 991 577 1494
Email
Navid.fp4m@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Nahid Barati
Position
Midwife
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Valiasr Hospital, Ghaffari St, Birjand City.
City
Birjand
Province
South Khorasan
Postal code
9716813448
Phone
+98 991 577 1494
Email
Navid.fp4m@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Nahid Barati
Position
Midwife
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Valiasr Hospital, Ghaffari St. Birjand City.
City
Birjand
Province
South Khorasan
Postal code
9716813448
Phone
+98 991 577 1494
Email
Navid.fp4m@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available