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To determine the effect of oral syrup of Plantago on postpartum hemorrhage

Protocol summary

Summary
Purpose: To determine the effect of oral syrup of Plantago on postpartum hemorrhage Design:Random sampling using random allocation software, double-blind, placebo-controlled Methods: A) The study population:The study population includes all women that will give birth in Ganjavian maternity clinic of Dezful, in 2017. The sample:The study sample consists of all eligible women that will give birth in Ganjavian maternity clinic of Dezful, in 2017. Inclusion criteria:Age of 20 to 35 years old, less than 3 pregnancies, gestational age between 37 to 42 weeks, singleton pregnancy with cephalic presentation and a fetal weigh between 2,500 to 4,000 grams, no pregnancy complications, no history of cesarean section or surgery on the uterus or postpartum hemorrhage, no systemic diseases, no magnesium sulfate consumption during pregnancy, clarity of the amniotic fluid during the first stage of labor, lack of wide episiotomy (rupture of grade 3 and 4) during the second stage of labor, normal duration of the first, second and third stages of labor, no severe postpartum hemorrhage, no severe hemorrhage during labor. Exclusion criteria:Hemorrhage during labor, unwillingness to continue to participate in the study, allergy to Plantago major, caesarean section. Sample size:94 people B) Intervention:Consumption of oral syrup of Plantago major and placebo. C) The primary outcome or studied outcomes: The effect on the volume of postpartum hemorrhage in the intervention group

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT201505283226N9
Registration date: 2017-08-24, 1396/06/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-08-24, 1396/06/02
Registrant information
Name
Mahrokh Dolatian
Name of organization / entity
Shahid Beheshti University of Medical Scenices
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2512
Email address
m_dolatian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-07-21, 1396/04/30
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To determine the effect of oral syrup of Plantago on postpartum hemorrhage
Public title
effect of oral syrup of Plantago on postpartum hemorrhage
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Age of 20 to 35 years old, less than 3 pregnancies, gestational age between 37 to 42 weeks, singleton pregnancy with cephalic presentation and a fetal weigh between 2,500 to 4,000 grams, no pregnancy complications, no history of cesarean section or surgery on the uterus or postpartum hemorrhage, no systemic diseases, no magnesium sulfate consumption during pregnancy, clarity of the amniotic fluid during the first stage of labor, lack of wide episiotomy (rupture of grade 3 and 4) during the second stage of labor, normal duration of the first, second and third stages of labor, no severe postpartum hemorrhage, no severe hemorrhage during labor. Exclusion criteria:Hemorrhage during labor, unwillingness to continue to participate in the study, allergy to Plantago major, caesarean section.
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 94
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Random sampling was done using random allocation software.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Nursing & Midwifery & Pharmacy Ettical Comitte of Shahid Beheshti University of Medica Science
Street address
Yaman street, next to Taleghani hospita, Shahid Beheshti University of Medical Sciences, Post code:198396-3113
City
Tehran
Postal code
1985717443
Approval date
2017-01-03, 1395/10/14
Ethics committee reference number
IR.SBMU.PHNM.1395.578

Health conditions studied

1

Description of health condition studied
Postpartum haemorrhage
ICD-10 code
O72.1
ICD-10 code description
haemorrhage after delivery of fetus or infant

Primary outcomes

1

Description
The amount of bleeding after delivery of the placenta and fetus
Timepoint
Every one hour for six hours
Method of measurement
Weighing pads and gowns in the first, second, third and sixth hour.

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
Control group:20 units of oxytocin in 1000 cc of Ringer's solution and 100 cc of the placebo syrup will be administered to the women in labor in two doses of immediately and 30 minutes after the expulsion of the placenta and the fetus.
Category
Placebo

2

Description
Intervention group:20 units of oxytocin in 1000 cc of Ringer's solution and 100 cc of Plantago major extract 20% will be administered to the women in labor in two doses, one immediately and one 30 minutes after the expulsion of the placenta and the fetus.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital Ganjavian city of Dezful
Full name of responsible person
Dolatian Mahrokh
Street address
Yaman street, next to Taleghani hospita, Shahid Beheshti University of Medical Sciences, Post code:198396-3113
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor for Research of Shahid Beheshti University of Medical Science
Full name of responsible person
Doctor M.Dolatian
Street address
Yaman street, next to Taleghani hospita, Shahid Beheshti University of Medical Sciences, Post code:198396-3113
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for Research of Shahid Beheshti University of Medical Science
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
Shahid Beheshti University of Medical Science
Full name of responsible person
Mahrokh Dolatian
Position
by research PhD / Assistant Professor / Faculty
Other areas of specialty/work
Street address
Yaman street, next to Taleghani hospita, Shahid Beheshti University of Medical Sciences, Post code:198396-3113
City
Tehran
Postal code
1985717443
Phone
+98 21 8820 2517
Fax
+98 21 8820 2522
Email
mhdolatian@gmail.comm_dolatian@sbmu.ac.ir
Web page address
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
Mahrokh Dolatian
Position
by research phd /assistant professor / faculty
Other areas of specialty/work
Street address
Yaman street, next to Taleghani hospita, Shahid Beheshti University of Medical Sciences, Post code:198396-3113
City
Tehran
Postal code
1985717443
Phone
+98 21 8820 2517
Fax
+98 21 8820 2522
Email
mhdolatian@gmail.com m_dolatian@sbmu.ac.ir
Web page address
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
Negin Nejati
Position
Masters student of Midwifery
Other areas of specialty/work
Street address
Yaman street, next to Taleghani hospita, Shahid Beheshti University of Medical Sciences, Post code:198396-3113
City
Tehran
Postal code
1985717443
Phone
+98 21 8820 2517
Fax
+98 21 8820 2522
Email
neginnejati71@gmail.om
Web page address
www.sbmu.ac.ir `

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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