Protocol summary

Summary
Comparison the effect of intravenous Tranexamic Acid and sublingual Misoprostol and Oxytocin to reducing of post- cesarean hemorrhage. Design:Randomized double blind clinical trial. Setting and conduct: All subjects will randomly devide in two groups of 75 and therapeutic interventions perform. Inclusion criteria are singleton pregnant women with 37- 40 weeks gestational ages, first gravida and maximum second gravida,previous cesarean section with lower segment incision. Exclusion criteria are preeclampsia, abnormal placenta, previous uterine rupture. Intervention: First group will receive 400 micrograms of sublingual Misoprostol after removing placenta.Second group,will injected 1gr of intravenous Tranexamic Acid into 20 c.c of 5% Dextrosewaters slowly before begining cesarean and both groups will receive 20 Units of Oxytocin after removing placenta immediatly. The volume of bleeding will measured by the bottle of suction set after removing placenta,the weight of cesarean set, consumed gases during the cessrean section. The blood pressure and pulse rate will be measured every 5 minutes during the section and every 30 minutes up to an hour after cesarean. Hemoglobin will be measured at the time of entering the ward and 24 hours after cesarean. One hour after cesarean occurrence of side effects such as fever, nausea, shivering will be evaluated. Patients up to 24 hours after cesarean will be monitored and in the event of sever bleeding an uterotonic drugs will be used. Main outcome measures: Hemoglobin values and volume of bleeding during cesarean section.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201708308611N6
Registration date: 2017-09-20, 1396/06/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-09-20, 1396/06/29
Registrant information
Name
Hamideh Pakniat
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 282242452
Email address
hpakniat@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and technology, Qazvin University of Medical Sciences
Expected recruitment start date
2017-01-30, 1395/11/11
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of intravenous Tranexamic Acid and sublingual Misoprostol and Oxytocin to reducing of post- cesarean hemorrhage
Public title
Comparison the effect of intravenous Tranexamic Acid and sublingual Misoprostol and Oxytocin to reducing of post- cesarean hemorrhage
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria are singleton pregnant women with 37- 40 weeks gestational ages, first gravida and maximum second gravida; previous cesarean section with lower segment incision. Exclusion criteria: preeclampsia; abnormal placenta; previous uterine rupture.
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The subjects are candidates for emergency or elective cesarean section, which are easily and randomly entered into the study.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Postal code
Approval date
2017-01-29, 1395/11/10
Ethics committee reference number
IR.QUMS.REC.1395.282

Health conditions studied

1

Description of health condition studied
Postpartum haemorrhage
ICD-10 code
O72
ICD-10 code description
Postpartum haemorrhage

Primary outcomes

1

Description
Blood pressure
Timepoint
Every 5 minutes during the section and every 30 minutes up to an hour after cesarean.
Method of measurement
Blood pressure monitor

2

Description
Pluse rate
Timepoint
Every 5 minutes during the section and every 30 minutes up to an hour after cesarean.
Method of measurement
Blood pressure monitor

3

Description
volume od bleeding
Timepoint
After removing placenta
Method of measurement
Through suction, weight of cesarean section's set and consumed gases

Secondary outcomes

1

Description
Nausea
Timepoint
One hour after cesarean section
Method of measurement
Ask the patient

2

Description
Hemoglobin
Timepoint
At the time of entering the patient's in the ward and 24 hours after cesarean section
Method of measurement
Blood sample

3

Description
Fever
Timepoint
One hour after cesarean section
Method of measurement
Thermometer

4

Description
Shivering
Timepoint
One hour after cesarean section
Method of measurement
Observation

Intervention groups

1

Description
Intervention group: first group will receive 400 micrograms of sublingual Misoprostol after removing placenta+ receive 20 Units of Oxytocin after removing placenta immediatly
Category
Treatment - Drugs

2

Description
Intervention group: second group,will injected 1gr of intravenous Tranexamic Acid into 20 c.c of 5% Dextrosewaters slowly before begining cesarean+ receive 20 Units of Oxytocin after removing placenta immediatly.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Azarmidokht Shojaei
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor for Research of Qazvin University of Medical Sciences
Full name of responsible person
Dr Amir Peymani
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
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 Qazvin University of Medical Sciences
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
Kowsar Hospital
Full name of responsible person
Azarmidokht Shojaei
Position
Resident
Other areas of specialty/work
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Postal code
Phone
+98 28 3223 6374
Fax
Email
dr.shojaei.mdgyn@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kowsar Hospital
Full name of responsible person
Dr Hamideh Pakniat
Position
Asistant Professor, Department of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Postal code
Phone
+98 28 3223 6374
Fax
Email
dr.shojaei.mdgyn@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kowsar Hospital
Full name of responsible person
Azarmidokht Shojaei
Position
Resident
Other areas of specialty/work
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Postal code
Phone
00
Fax
Email
dr.shojaei.mdgyn@gmail.com
Web page address

Sharing plan

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