Determining the effect of sumac capsule on postpartum hemorrhage in women at risk of bleeding
Design
Clinical trial with control group, parallel groups, triple blind, randomized.
Settings and conduct
The present study is a triple-blind clinical trial (research unit, researcher, statistical analyst) which is performed on 72 eligible mothers who referred to Torbat Heydariyeh Hospital for vaginal delivery.
Eligible mothers are selected in an accessible manner, and would be randomly allocated into intervention and control groups. Sumac and placebo capsules are coded by the assistant professor of pharmacology.Bleeding is measured by weighing disposable Droschit and pads before and after using the drug and at the end of the first, second, third and fourth hours after delivery.
Participants/Inclusion and exclusion criteria
Conditions included: 15-50 years,
Tendency to have a normal delivery. Term pregnancy. No history of allergy to sumac.Absence of severe bleeding during childbirth.Conditions not included:Serious postpartum complications.The mother's unwillingness to continue participating in the study.The need for invasive actions and medication to control severe postpartum hemorrhage
Intervention groups
Intervention group: In addition to the routine oxytocin method, is given dry sumac immediately after placental abruption and 2 hours later.
Placebo group: In addition to the routine method, will be given placebo (500 mg capsule containing an inert substance (Avisel powder) immediately after placental abruption and 2 hours later.
Main outcome variables
Postpartum hemorrhage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220314054275N1
Registration date:2022-06-23, 1401/04/02
Registration timing:registered_while_recruiting
Last update:2022-06-23, 1401/04/02
Update count:0
Registration date
2022-06-23, 1401/04/02
Registrant information
Name
Mahsa Payranj
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5222 6016
Email address
payranjm982@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-20, 1401/03/30
Expected recruitment end date
2022-09-06, 1401/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sumac capsule on postpartum hemorrhage in women at risk of bleeding
Public title
The effect of sumac capsule on postpartum hemorrhage in women at risk of bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Written consent to participate in the study
Iranian and resident of Torbat Heydariyeh
Literacy
age range between 15-50
Tendency to have a normal delivery
Term pregnancy
Beginning of the active phase of labor
Achieve a score equal to or greater than 10% of the prognosis of postpartum hemorrhage
No major medical illness
No history of cesarean section or uterine surgery
lack of take Special drugs
lack of Grade 3 and 4 rupture
lack of severe bleeding during childbirth
lack of herbal or chemical drugs before childbirth and during labor and delivery
lack of rupture of cervix and uterus
lack of labor complications in the active phase of labor
lack of Temperatures greater than 38 ° C during the study
lack of rupture of fetal membranes for more than 12 hours
Lack of fast labor
Lack of prolonged labor
No history of allergy to sumac, according to the mother's report
lack of Cesarean delivery
Exclusion criteria:
Serious postpartum complications in the mother
The mother's unwillingness to continue participating in the study
Occurrence of any allergy to sumac
Leakage of urine during blood collection
Need for invasive actions and medication to control severe postpartum hemorrhage (sample will be recorded and excluded)
Age
From 15 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
To ensure an equal number of subjects in the two groups, the permutation block method will be used. For this purpose, we will use the website www.sealedenvelope.com in such a way that a number of 6 and 4 member blocks are accidentally created through the above site. Examples of blocks can be: [ABAB], [ABBAAB], [BBAABA], [BAAABB],…Sumac and placebo capsules are coded by the assistant professor of pharmacology and the researcher is unaware of which drug and which placebo. At the end of the analysis, the researcher and professor of statistics, will be revealed that which group has been drugs and placebo.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Sumac and placebo capsules are coded by the assistant professor of pharmacology and the researcher is unaware of which drug and which placebo. At the end of the analysis, the researcher and professor of statistics will be revealed that which group has been drugs or placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Qureshi Building University Street, Mashhad, Iran
City
mashhad
Province
Razavi Khorasan
Postal code
9173595199
Approval date
2022-03-15, 1400/12/24
Ethics committee reference number
IR.MUMS.NURSE.REC.1401.005
Health conditions studied
1
Description of health condition studied
Postpartum haemorrhage
ICD-10 code
JA43.0
ICD-10 code description
A condition characterised by excessive loss of blood during the third stage of labour for a vaginal delivery. This condition is caused by uterine atony, trauma, retained placenta, or coagulopathy
Primary outcomes
1
Description
The amount of postpartum hemorrhage
Timepoint
at the end of 1, 2, 3 and 4 hours after delivery
Method of measurement
Weighing blood collection bags and blood-soaked pads
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to routine method of oxytocin , intervention group will be given two oral capsules of 500 mg of dry sumac extract with a yield of 30% (equivalent to 1 gram of sumac) immediately after placental abruption and 2 hours later.
Category
Treatment - Drugs
2
Description
Control group: In addition to the routine method of oxytocin , will be given placebo (500 mg capsule containing an inert substance (Avisel powder) immediately after placental abruption and 2 hours later.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان نهم دی
Full name of responsible person
Dr. Hossein Dinpanah Khoshderegi
Street address
Khorasan Razavi - Torbat Heydariyeh - Ayatollah Kashani Street - in front of Kashani Park
City
Torbat heydariyeh
Province
Razavi Khorasan
Postal code
31166-95188
Phone
+98 51 5222 6016
Email
foad_0004@yahoo.com
Web page address
https://www.thums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Ghayyur Mobarahan
Street address
Qureshi Building University St., Vice Chancellor for Research and Technology, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
917751365
Phone
+98 51 3882 5523
Email
ghayourM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mahsa Payranj
Position
Master's degree student of reproductive health
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Crossroads Doctora, Ibne Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
0098 51 38591511-3
Email
payranjm982@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Moradi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Crossroads Doctora, Ibne Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
0098 51 3-38591511-3
Email
moradim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahsa payranj
Position
Master's degree student of reproductive health
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Crossroads Doctora, Ibne Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
0098 51 38591511-3
Email
payranjm982@mums.ac.ir
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
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
Yes - There is 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
Not applicable
Title and more details about the data/document
Publication of research results in the form of scientific article printing
When the data will become available and for how long
data will become available after publication of the article.
To whom data/document is available
The general public and all researchers
Under which criteria data/document could be used
To inform the public about the reduction of postpartum hemorrhage rate in women at risk of bleeding and scientific use based on the article.
From where data/document is obtainable
Dr. Maryam Moradi, Assistant Professor, Mashhad School of Midwifery Nursing, e-mail: moradim@mums.ac.ir
What processes are involved for a request to access data/document
Request to access data/documents would be assessed by the research team.