To determine effect of the hydro-alcoholic extract of Achillea millefolium on early postpartum hemorrhage
Design
A randomized, triple blind, placebo-controlled clinical trial with a parallel groups design of 100 patients, divide into two groups through random allocation in Excel
Settings and conduct
The present clinical trial conduct on 100 primiparous women presenting to Afzalipour Hospital in Kerman. The intervention group receive ten sublingual drops of hydro alcoholic extract of Achillea millefolium plus routine treatment and the control group received ten sublingual drops of the placebo (saline 9.0%) plus routine treatment.
Then, all samples assesse until 3 hour after delivery for estimation of postpartum hemorrhage and pulse rate and blood pressure.6 hours after delivery hemoglobin and hematocrite were checked for estimation of postpartum hemorrhage. The hydro-alcoholic extract and placebo labelle A and B by the pharmacist, and so both the participants and the researchers are blinded to the type of treatment administered.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 20 and 35 years old; gestational ages between 37 to 42 weeks; singleton birth with cephalic presentation; child weigh between 2500 to 4000 grams; amniotic fluid is clear on during stages of labor; normal during the first phase
the number of pregnancies less than 3. Exclusion criteria: systemic diseases (diabetes, hypothyroidism, coagulation disorders ); cesarean section or uterine surgery or postpartum; complications of pregnancy (poly hydramynus, bleeding and hypertension in pregnancy); use the magnesium sulfate during pregnancy; large episiotomy during the second stage of labor.
Intervention groups
Ten sublingual drops of hydro alcoholic extract of Achillea millefolium
Main outcome variables
Postpartum hemorrhage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160112025983N2
Registration date:2019-06-22, 1398/04/01
Registration timing:registered_while_recruiting
Last update:2019-06-22, 1398/04/01
Update count:0
Registration date
2019-06-22, 1398/04/01
Registrant information
Name
Hadis Shahrahmani
Name of organization / entity
School of Nursing and Midwifery of Shahid Beheshti
Country
Iran (Islamic Republic of)
Phone
+98 21 23871
Email address
hadis.rahmani92@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-20, 1397/10/30
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the hydro-alcoholic extract of Achillea millefolium on early postpartum hemorrhage
Public title
The effect of Achillea millefolium on early postpartum hemorrhage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The age between 20 and 35 years
Gestational ages between 37 to 42 weeks
Singleton birth with cephalic presentation child weigh between 2500 to 4000 grams
Amniotic fluid is clear
Normal during the first phase
The number of pregnancies less than 3
Exclusion criteria:
Systemic diseases (diabetes, hypothyroidism, coagulation disorders )
Cesarean section or uterine surgery or postpartum
Complications of pregnancy (poly hydramynus, bleeding and hypertension in pregnancy)
Use the magnesium sulfate during pregnancy
Large episiotomy during the second stage of labor
Age
From 20 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects divide into two groups through random allocation in Excel
Blinding (investigator's opinion)
Triple blinded
Blinding description
For blinding purposes, all the assessments perform by a person who is blinded to the type of treatment give to the mothers.
The hydro-alcoholic extract of Achillea millefolium and placebo labelle A and B by the pharmacist, and so both the participants and the researchers are blinded to the type of treatment administered.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences, Campus, Haftbagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2019-02-20, 1397/12/01
Ethics committee reference number
IR.KMU.REC.1397.466
Health conditions studied
1
Description of health condition studied
Postpartum hemorrhage
ICD-10 code
O72.1
ICD-10 code description
Postpartum hemorrhage
Primary outcomes
1
Description
Amount of bleeding
Timepoint
One hour, two hours, three hours after delivery
Method of measurement
Weighing pad and drape
Secondary outcomes
1
Description
Hemoglobin and hematocrit level
Timepoint
On admission and 6 hours after delivery
Method of measurement
Blood Test
Intervention groups
1
Description
Intervention group: Ten sublingual drops of hydro alcoholic extract of Achillea millefolium ( equivalent 10 grams of plant )
Category
Treatment - Drugs
2
Description
Control group: Ten sublingual drops of placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Hadis Shahrahmani
Street address
Emam Highway, Afzalipour Hospital, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Email
hadis.shahrahmani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences/Deputy of research and technology
Full name of responsible person
Hadis Shahrahmani
Street address
Kerman University of Medical Sciences, Campus, Haftbagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5000
Email
hadis.shahrahmani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences/Deputy of research and technology
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
Kerman University of Medical Sciences
Full name of responsible person
Hadis Shahrahmani
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Kerman University of Medical Sciences, Campus, Haftbagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5000
Email
hadis.shahrahmani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hadis Shahrahmani
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Kerman University of Medical Sciences, Campus, Haftbagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5000
Email
hadis.shahrahmani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hadis Shahrahmani
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Kerman University of Medical Sciences, Campus, Haftbagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5000
Email
hadis.shahrahmani@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
Not applicable
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