Protocol summary

Study aim
To compare the effect of extracts of the date, dill and grape seed versus placebo on postpartum hemorrhage in fourth stage of labor
Design
This is a double-blind randomized clinical trial, in which 200 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible pregnant women for normal delivery who will refer to Fatemieh Hospital in Hamadan City during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded so that neither patients nor the physician who will examine the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 18 to 40 years Normal body mass index, Gestational age between 37 to 41 weeks, Normal childbirth, Second pregnancy without the need for episiotomy, Normal length of the first, second and third stages of delivery, Abnormal bleeding Exclusion criteria: Any complications of pregnancy, Fetal weight between 2500 and 4000 grams, Cephalic presentation, Chronic diseases such as cardiopulmonary, kidney, diabetes, or thalassemia
Intervention groups
Intervention group 1: Infusion of oxytocin 300 U in 500 ml Ringer's serum plus lavage with warm water containing 70% date extract Intervention group 2: Infusion of oxytocin 300 U in 500 ml Ringer's serum plus lavage with warm water containing 70% dill extract Intervention group 3: Infusion of oxytocin 300 U in 500 ml Ringer's serum plus lavage with warm water containing 70% grape seed extract Control group: Infusion of oxytocin 300 U in 500 ml Ringer's serum plus lavage with warm water containing placebo
Main outcome variables
Primary outcome: Hemorrhage in the fourth stage of labor

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120215009014N300
Registration date: 2019-09-24, 1398/07/02
Registration timing: prospective

Last update: 2019-09-24, 1398/07/02
Update count: 0
Registration date
2019-09-24, 1398/07/02
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-12, 1398/07/20
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of extracts of the date, dill and grape seed versus placebo on postpartum hemorrhage in fourth stage of labor: a double-blind randomized clinical trial
Public title
Comparison of the effect of extracts of the date, dill and grape seed versus placebo on postpartum hemorrhage in fourth stage of labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 40 years Normal body mass index, Gestational age between 37 to 41 weeks, Normal childbirth, Second pregnancy without the need for episiotomy, Normal length of the first, second and third stages of delivery, Abnormal bleeding
Exclusion criteria:
Any complications of pregnancy, Fetal weight between 2500 and 4000 grams, Cephalic presentation, Chronic diseases such as cardiopulmonary, kidney, diabetes, or thalassemia
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare eight sheets of paper, writing on two sheets the name of the intervention 1, on two other sheets the name of the intervention 2, on two other sheets the name of the intervention 3 and on the third two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all six sheets are drawn. The eight paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as triple blind
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2019-09-14, 1398/06/23
Ethics committee reference number
IR.UMSHA.REC.1398.475

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
Hemorrhage in the fourth stage of labor
Timepoint
One and two hours after the intervention
Method of measurement
By physical examination

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Infusion of oxytocin 300 U in 500 ml Ringer's serum plus lavage with warm water containing 70% date extract
Category
Treatment - Other

2

Description
Intervention group 2: Infusion of oxytocin 300 U in 500 ml Ringer's serum plus lavage with warm water containing 70% dill extract
Category
Treatment - Other

3

Description
Intervention group 3: Infusion of oxytocin 300 U in 500 ml Ringer's serum plus lavage with warm water containing 70% grape seed extract
Category
Treatment - Other

4

Description
Control group: Infusion of oxytocin 300 U in 500 ml Ringer's serum plus lavage with warm water containing placebo
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh Hospital in Hamadan City
Full name of responsible person
Arezoo Shayan
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
arezoo.shayan2012@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Arezoo Shayan
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
arezoo.shayan2012@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Arezoo Shayan
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
arezoo.shayan2012@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir

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
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
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