To determine the effect of the hydro-alcoholic extract of Urtica Dioica on early postpartum hemorrhage
Design
Three‐blind clinical trial with a parallel groups and placebo-controlled, design of100 patients, randomized
Settings and conduct
The present three‐blind clinical trial will conduct on 100 women presenting to Afzalipour Hospital in Kerman.
The participants will select and randomly assign into an intervention group (n = 50) and a placebo group (n = 50). The intervention group will be given 10 sublingual drops of the hydroalcoholic extract of Urtica Dioica and the control group will be given 10 sublingual drops of the placebo.
The amount of bleeding will assess in both groups
The hydro-alcoholic extract and placebo will be labelled A and B by The amount of bleeding was assessed in both groupsthe pharmacist, and so both the participants and the researchers will blinded to the type of treatment administered.
Participants/Inclusion and exclusion criteria
Age between 20 and 35 years
Gestational age between 37 and 42 weeks
Single fetus with a cephalic presentation and fetal weight between 2500 and 4000 g
Clear amniotic fluid
less than three pregnancies
Known systemic diseases (diabetes, hypothyroidism, and coagulation disorders)
History of cesarean section, uterine surgery, or PPH
Pregnancy complications (polyhydramnios and gestational bleeding and hypertension)
Use of magnesium sulfate during pregnancy
Extensive episiotomy in the second stage of labor
Intervention groups
Ten sublingual drops of hydro alcoholic extract of Urtica Dioica
Main outcome variables
Postpartum hemorrhage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160112025983N3
Registration date:2019-07-17, 1398/04/26
Registration timing:retrospective
Last update:2019-07-17, 1398/04/26
Update count:0
Registration date
2019-07-17, 1398/04/26
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
2019-02-03, 1397/11/14
Expected recruitment end date
2019-04-03, 1398/01/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of the hydro-alcoholic extract of Urtica Dioica on early postpartum hemorrhage
Public title
Effect of Urtica Dioica on early postpartum hemorrhage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 and 35 years
Gestational ages between 37 to 42 weeks
Single fetus with a cephalic presentation, fetal weight between 2500 and 4000 g
Clear amniotic fluid in the first stage of labor
Normal during the first phase
less than three pregnancies
Exclusion criteria:
Systemic diseases (diabetes, hypothyroidism, and coagulation disorders)
Cesarean section or uterine surgery or postpartum hemorrhage
Complications of pregnancy (poly hydramynus, gestational bleeding and hypertension)
Use of magnesium sulfate during pregnancy
Extensive episiotomy in the second stage of labor
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
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 eligible participants will be randomly assigned to the Urtica Dioica and control groups using simple randomization sequences.
Sequential numbered, sealed, opaque envelopes will be used to allocation concealment.
Blinding (investigator's opinion)
Double blinded
Blinding description
The hydro-alcoholic extract of Achillea millefolium and placebo will be labelled A and B by the pharmacist, and so both the participants and the researchers will be blinded to the type of treatment administered.
For blinding purposes, all the assessments performe by a
person who will be blinded to the type of treatment given to the mothers.
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
2018-12-14, 1397/09/23
Ethics committee reference number
IR.KMU.REC.1397.465
Health conditions studied
1
Description of health condition studied
Postpartum hemorrhage
ICD-10 code
O72
ICD-10 code description
Postpartum hemorrhage
Primary outcomes
1
Description
Amount of bleeding
Timepoint
One hour, two hours and three hours after delivery
Method of measurement
Weighing the pads and drapes
Secondary outcomes
1
Description
Hemoglobin and hematocrit levels
Timepoint
6 hours after delivery
Method of measurement
Blood Test
Intervention groups
1
Description
Intervention group: Ten sublingual drops of hydroalcoholic extract of Urtica Dioica
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
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
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