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The effect of pressure on Gallbladder points on Postpartum Hemorrhage after vaginal delivery

Protocol summary

Study aim
Determining the effect of pressure on the gallbladder points on the amount of bleeding after vaginal delivery
Design
Clinical trial with control group, with parallel groups without blinding, accidental phase 3 on 70 women. The random number table was used for randomization.
Settings and conduct
In the third stage of labor, immediately after removal of the fetus and simultaneous infusion of 20 IU oxytocin, according to national guideline natural childbirth, in groups of 60 seconds on each of the cranial gallbladder (GB8-GB16-GB17-GB18) (collectively 4 minutes) apply. After the expulsion of the placenta and the completion of the third stage of labor, every 15 minutes to an hour (4 cycles) and then every 30 minutes to an hour (two cycles) one cycle of pressure on parts of the above apply (7 cycles Pressure: 28 min pressure )
Participants/Inclusion and exclusion criteria
Active phase of the ligament (5-3 cm dilation of the cervix at the beginning of the study), singleton pregnancy, healthy and live fetus, admission for vaginal delivery, gestational age 42-37 weeks, Vertex display, no internal disease and surgery,, no delivery with equipment, No rupture of the uterus or cervix, no accelerated ligament (less than 3 hours), no use of relaxing medications such as magnesium sulfate or halogenated anesthesia, no heavy bleeding before the intervention, no rupture of grades 3 and 4, no macrosomic (weight) Fetus more than 4.5 kg), no severe and arterial bleeding from the rupture or epithelium, no manual removal of placenta and placenta, no need for additional routine treatments such as metrogen, misoprostrol
Intervention groups
In the intervention group, in addition to receiving normal care, acupressure is applied to 4 points of the skull.
Main outcome variables
Postpartum hemorrhage

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200608047685N1
Registration date: 2020-06-30, 1399/04/10
Registration timing: prospective

Last update: 2020-06-30, 1399/04/10
Update count: 0
Registration date
2020-06-30, 1399/04/10
Registrant information
Name
Elaheh Mansouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3273 5002
Email address
mansourie94150@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pressure on Gallbladder points on Postpartum Hemorrhage after vaginal delivery
Public title
Investigating the effect of acupressure on postpartum hemorrhage
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Single pregnancy Healthy and alive fetus Admission for vaginal delivery Pregnancy age 42-37 weeks Vertex position Lack of internal disease and surgery Absence of any scar or wound on the acupressure point No history of cesarean section or previous uterine surgery Body mass index less than 30 Absence of high-risk pregnancy (gestational diabetes, pregnancy hypertension ...) Fourth and less pregnancy
Exclusion criteria:
Childbirth with vacuum and forceps Rupture of the uterus or cervix Accelerated Liber (less than 3 hours) Use relaxing medications such as magnesium sulfate or halogenated anesthesia Severe bleeding before the intervention Grade 3 and 4 tears Macrosomia (fetal weight greater than 4.5 kg) Severe arterial bleeding from the tear or episiotomy Manual removal of placenta and membranes Requires additional rutin treatments such as metrogen, misoprostrol
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
simple.In this method, a table of random numbers is used for randomization. In this way, in order to read random numbers in the mentioned table, from top to bottom, the even numbers are considered for the intervention group and the individual numbers are considered for the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Ebnesina Ave,Doktora Cross
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2020-04-28, 1399/02/09
Ethics committee reference number
IR.MUMS.NURSE.REC.1399.006

Health conditions studied

1

Description of health condition studied
post partum hemorrhage
ICD-10 code
o72.1
ICD-10 code description

Primary outcomes

1

Description
Postpartum hemorrhage
Timepoint
2 hours after delivery, placentas and membranes
Method of measurement
Plastic bags collect blood

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the third stage of labor, immediately after removal of the fetus and simultaneous infusion of 20 IU oxytocin, according to national guideline natural childbirth, in groups of 60 seconds on each of the cranial gallbladder (GB8-GB16-GB17-GB18) (collectively 4 minutes) apply. After the expulsion of the placenta and the completion of the third stage of labor, every 15 minutes to an hour (4 cycles) and then every 30 minutes to an hour (two cycles) one cycle of pressure on parts of the above apply (7 cycles Pressure: 28 min pressure ) (distances pressure on the precise location of the control points of the fourth stage of labor, vaginal delivery, according to national guideline, is.Immediately after the placenta is removed, the plastic bags of blood collected by the researcher are placed under the mother's buttocks, and after 2 hours, the blood in these bags is weighed.
Category
Prevention

2

Description
Control group: In the control group, normal care of the fourth stage of labor (including injection of 20 units of intravenous oxytocin and uterine massage at intervals of 15 minutes in the first hour after delivery and every 30 minutes in the second hour of delivery), as well as the intervention group at the stated intervals. Immediately after the placenta is removed, the plastic blood collection bags are placed under the mother's buttocks by the researcher, and after 2 hours, the blood in these bags is weighed.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Omolbanin Hospital
Full name of responsible person
Elaheh Mansouri
Street address
Next to the Ayatollah Behjat16.Crossroad Zarineh
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3223 1061
Email
mansourie94150@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen tafaghodiy
Street address
School of Pharmacy, University Campus,Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3180 1100
Email
mansourie94150@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mansouri
Position
مربی
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ebnesina st,DoctoraCrossroad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3273 5002
Email
mansourie94150@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
mansouri
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ebnesina st,DoctoraCrossroad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3273 5002
Email
mansourie94150@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
mansouri
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ebnesina st,DoctoraCrossroad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3273 5002
Email
mansourie94150@mums.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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