The Effect of Tranexamic Acid on Postpartum Hemorrhage Du... | NCT01085006

Studies
The Effect of Tranexamic Acid on Postpartum Hemorrhage During and After Cesarean Delivery

NCT01085006

Sponsor

Tehran University of Medical Sciences

Status

Completed

Last Update Posted

Jan 25, 2011Estimated

Enrollment

100Actual

Phase

Phase 1Phase 2

Conditions

Hemorrhage

Interventions

Tranexamic acid
Normal saline

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

Participant Flow Module

Pre-assignment Details

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Aug 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Mar 10, 2010

First Submission Date that Met QC Criteria

Mar 10, 2010

First Posted Date

Mar 11, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Jan 2, 2011

Results First Submitted that Met QC Criteria

Jan 2, 2011

Results First Posted Date

Jan 25, 2011Estimated

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 2, 2011

Last Update Posted Date

Jan 25, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Tehran University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Intravenous Tranexamic acid is used to reduce the hemorrhage during and after cesarean delivery in a double blind randomized placebo controlled trial.

Detailed Description

Not provided

Conditions Module

Conditions

Hemorrhage

Keywords

cesarean delivery
Tranexamic acid
hemorrhage
Spinal analgesia
1-the amount of hemorrhage during cesarean delivery
2-the amount of hemorrhage in the first 2 hours of cesarean delivery
3-the amount of hemorrhage in the first 24 hour after cesarean delivery

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tranexamic acid	Experimental		Drug: Tranexamic acid
normal saline infusion	Placebo Comparator		Drug: Normal saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tranexamic acid	Drug	Tranexamic acid in cases, normal saline in controls	Tranexamic acid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Amount of Hemorrhage During Cesarean Delivery and Within 2 Hours Afterward		During the procedure and within 2 hours afterwards

Secondary Outcomes

Measure	Description	Time Frame
Amount of Hemorrhage in the First 24 Hour After Cesarean Delivery		First 24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Term pregnancy
Single fetus
Maximally only one previous cesarean delivery

Exclusion Criteria:

More than one previous cesarean delivery
Hx of other abdominal or pelvic surgery
Hx of medical disorders
Hx of thromboembolic disorders
Polyhydramnios
Macrosomia
Preeclampsia
Hx of sensitivity to Tranexamic acid
Abnormal Pt, PTT, PT or INR

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laleh Eslamian, MD	Associated Prof, Obstetrician & Gynecologist	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Laleh Eslamian		Tehran		14114	Iran

ID	Title	Description
FG000	Tranexamic Acid
FG001	Normal Saline Infusion

Baseline Characteristics Module

Baseline Analysis Population Description

Not provided

Type of Units Analyzed

Not provided

Arm/Group Information

ID	Title	Description
BG000	Tranexamic Acid
BG001	Normal Saline Infusion
BG002	Total

Denominators

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

The Amount of Hemorrhage During Cesarean Delivery and Within 2 Hours Afterward

Posted

Median

Full Range

During the procedure and within 2 hours afterwards

ID	Title	Description
OG000	Tranexamic Acid
OG001	Normal Saline Infusion

Units	Counts
Participants	OG000

Adverse Events Module

Frequency Threshold

Time Frame

Not provided

Description

Not provided

All-Cause Mortality Comment

Not provided

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Tranexamic Acid

Serious Adverse Events

Not provided

Other Adverse Events

Not provided

More Info Module

Limitations and Caveats

Not provided

Certain Agreements

Are all PI(s) employees of the sponsor?

Yes

Restriction Type

Point of Contact

Title	Organization	Phone	Extension	Email
Dr. Laleh Eslamian	Tehran University of Medical Sciences	+982184902415		leslamian@tums.ac.ir

Condition Browse Module

MeSH Terms

ID	Term
D006470	Hemorrhage

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014148	Tranexamic Acid
D000077330	Saline Solution

Ancestor Terms

ID	Term
D003509	Cyclohexanecarboxylic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided