Investigating The effect of plantago capsules on postpartum hemorrhage after normal vaginal delivery i
Design
his study is a randomized, double-blind experimental work with a control group that will be conducted in Nik Nafs maternity hospital in Rafsanjan city.
Mothers are randomly selected using a ball
Settings and conduct
This study is a double-blind clinical trial conducted in Rafsanjan city
Participants/Inclusion and exclusion criteria
nclusion criteria:
1. Gestation age 37-42 weeks
2. Number of pregnancies less than 3
3. Having a single fetus and cephalic presentation
4. Baby weight between 2500-4000 grams
5. Absence of pregnancy complications (polyhydramnios, bleeding and pregnancy blood pressure)
6. No history of cesarean section and uterine surgery or postpartum bleeding
7. Not suffering from systemic diseases (diabetes, hypothyroidism, coagulation disorders)
8. Not using magnesium sulfate during pregnancy
9. Absence of wide episiotomy (3rd and 4th degree tear) during the second stage of labor
10. The normal length of the first, second and third stages of labor
11. Not using herbal or chemical medicines before delivery and during labor and delivery
12. Occurrence of severe bleeding during childbirth (more than 500 cc) and receiving drug treatment
Exit criteria:
1. Mother's unwillingness to continue participating in the study
2. Cause any sensitivity to Barhang
3. Metritis or postpartum infections
4. Using other drugs to prevent bleeding
5. Forgetting more than 48 hours of taking capsules
Intervention groups
People will be divided into two intervention and control groups. In the intervention group (40 people), from 24 hours after delivery, two capsules of barhang and The control group (40 people) will receive placebo capsules containing corn starch powder.
Main outcome variables
Barhang capsule consumption;Bleeding score;Number of days of bleeding
Age;Level of Education;Job
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240429061586N1
Registration date:2026-01-05, 1404/10/15
Registration timing:retrospective
Last update:2026-01-05, 1404/10/15
Update count:0
Registration date
2026-01-05, 1404/10/15
Registrant information
Name
Narges Khodadadpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 2173
Email address
info@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-26, 1403/07/05
Expected recruitment end date
2025-06-01, 1404/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating The effect of plantago capsules on postpartum hemorrhage after normal vaginal delivery
Public title
Investigating The effect of plantago capsules on postpartum hemorrhage after normal vaginal delivery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestation age 37-42 weeks
Number of pregnancies less than 3
Having a single embryo and cephalic presentation
The weight of the baby is between 2500-4000 grams
Absence of pregnancy complications (polyhydramnios, bleeding and pregnancy blood pressure)
No history of cesarean section and uterine surgery or postpartum bleeding
Not suffering from systemic diseases (diabetes, hypothyroidism, coagulation disorders)
Not taking magnesium sulfate during pregnancy
Absence of a wide episiotomy (grade 3 and 4 tears) during the second stage of labor
The normal length of the first, second and third stage of labor
Not using herbal or chemical medicines before delivery and during labor and delivery
Severe bleeding during delivery (more than 500 cc) and receiving medical treatment
Exclusion criteria:
Presence of pregnancy complications (polyhydramnios, bleeding and pregnancy blood pressure)
history of cesarean section and uterine surgery or postpartum bleeding
suffering from systemic diseases (diabetes, hypothyroidism, coagulation disorders)
taking magnesium sulfate during pregnancy
Presence of a large episiotomy (grade 3 or 4 tear) during the second stage of labor
Abnormal length of the first, second, and third stages of labor
using herbal or chemical medicines before delivery and during labor and delivery
Severe bleeding during delivery (more than 500 cc) and receiving medical treatment
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
thers are placed in one of the two groups of receiving Barhang capsule or control by random allocation, in such a way that the first person takes one of the two balls on which the letter a or b is written, and the next person is in the opposite group and until the end of the sample The acquisition continues in the same way.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants is not aware of which group they are in, and the data analyst is not aware of which group the data belongs to.
Plantain seed powder and lactose are filled into capsules of the same color and size and finally packaged in identical cans. Each patient takes two capsules daily, 12 hours apart, for 2 weeks. The cans of medication are coded by the pharmacist. participants and the analyst are unaware of the contents of the cans.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Sciences
Street address
Nurse Street
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Approval date
2024-09-14, 1403/06/24
Ethics committee reference number
IR.RUMS.REC.1403.085
Health conditions studied
1
Description of health condition studied
postpartum hemorrhage after normal vaginal delivery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
postpartum hemorrhage after normal vaginal delivery
Timepoint
Checking the amount of bleeding 24 hours after delivery for 40 days
Method of measurement
PBAC form(PBAC Scoring System)
Secondary outcomes
1
Description
postpartum hemorrhage after normal vaginal delivery
Timepoint
Bleeding rate 24 hours after delivery for 40 days
Method of measurement
PBAC form
Intervention groups
1
Description
Intervention group:In the intervention group (40 people), starting 24 hours after delivery, two capsules of plantain (containing 750 mg of plantain seed powder obtained by hydroalcoholic method and preserving its astringent compounds) are administered orally daily for 2 weeks. The method of preparing the capsules is as follows: plantain seeds will be obtained from an apothecary in Rafsanjan city. The seeds purchased at the Kerman Faculty of Traditional Medicine are examined by a botanist and after confirming the genus and species name, a herbarium number is assigned to them. In order to initially check the quality of the purchased samples, the amount of total ash, acid-insoluble ash, moisture, and percentage of extract obtained from the plant are determined using the methods mentioned in the herbal pharmacopoeia. To prepare the final product, the plantain seeds are first carefully examined to ensure that they do not contain foreign components or impurities. The seeds will be powdered with an electric grinder. The seed powder is filled into size 2 capsules with a long base using a manual capsule filling machine. Each capsule contains 750 mg of plantain. Plantain seed powder and lactose are filled into capsules of the same color and size and finally packaged in identical cans. Each patient takes two capsules daily at 12-hour intervals for 2 weeks. The medicine cans are coded by the pharmacist and the obstetrician and analyst are unaware of the contents of the cans. During 40 days, by forming a group in cyberspace, individuals are followed up daily for taking the medicine and filling out the relevant form and the explanations are reminded again and at the end of this 40-day period, the filled forms are delivered to comprehensive health centers. In the case of samples that are not able to visit health centers, they will also be followed up separately and the forms will be delivered in person. The average days and bleeding score in the two intervention and control groups are evaluated and compared.
Category
Treatment - Drugs
2
Description
Control group:The control group (40 people) receives placebo capsules containing lactose. Lactose-containing capsules are used as placebo. Plantain seed powder and lactose are filled into capsules of the same color and size and finally packaged in identical cans. Each patient takes two capsules daily at 12-hour intervals for 2 weeks. The drug cans are coded by the pharmacist, and the nurse and the analyst do not know the contents of the cans. During 40 days, by forming a group in cyberspace, people are followed up daily to take the drug and fill out the relevant form, and the explanations are reminded again, and at the end of this 40-day period, the filled forms are delivered to comprehensive health centers. In the case of samples that are not able to visit health centers, they will also be followed up separately and the forms will be delivered in person. The average days and bleeding score in the two intervention and control groups are evaluated and compared.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Nik Nafs Maternity Hospital Rafsanjan
Full name of responsible person
Dr.Mirmotalebi
Street address
Shahada St
City
Rafsanjan
Province
Kerman
Postal code
7716648995
Phone
+98 34 3129 8800
Email
Niknafs@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Mohammadi
Street address
Nurse Street
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Email
Parstari@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Narges .Khodadadpour
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Kargar St
City
Rafsanjan
Province
Kerman
Postal code
7716648995
Phone
+98 34 3425 2173
Email
nargeskhodadadpour1400@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Narges Khodadadpour
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Kargar St
City
Rafsanjan
Province
Kerman
Postal code
7716648995
Phone
+98 34 3425 2173
Email
nargeskhodadadpour1400@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Narges Khodadadpour
Position
Consultant
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.13 kargar Alley 6 kargar Blvd Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7716648995
Phone
+98 34 3425 2173
Fax
Email
nargeskhodadadpour1400@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
In this study, personal information cannot be published, but information about the results and analysis is accessible
When the data will become available and for how long
Access starts 7 months after publication
To whom data/document is available
Researchers working in academic institutions and interested students can access the information
Under which criteria data/document could be used
Data can be used by mentioning the source
From where data/document is obtainable
For people, if they refer to my email, if the request is allowed, an email will be sent within a few days. nargeskhodadadpour1400@yahoo.com
What processes are involved for a request to access data/document
It can be accessed by visiting Rafsanjan University of Medical Sciences or a personal email will be sent within a few days if allowed