Tranexamic Acid for Preventing Postpartum Hemorrhage Afte... | NCT02936661

Studies
Tranexamic Acid for Preventing Postpartum Hemorrhage After Cesarean Section

NCT02936661

Sponsor

Shanghai First Maternity and Infant Hospital

Status

Unknown status

Last Update Posted

Oct 18, 2016Estimated

Enrollment

6,700Estimated

Phase

Phase 4

Conditions

Postpartum Hemorrhage， Cesarean Section

Interventions

Tranexamic Acid
Placebo

Countries

Not provided

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

No data available

No data is available for this block.

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

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2017

Primary Completion Date

Dec 2018Estimated

Completion Date

Mar 2019Estimated

First Submitted Date

Oct 15, 2016

First Submission Date that Met QC Criteria

Oct 17, 2016

First Posted Date

Oct 18, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

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

Oct 17, 2016

Last Update Posted Date

Oct 18, 2016Estimated

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

It is a multicenter randomized, double-blind and placebo-controlled trial. Totally 6500 women to delivery by cesarean section will be recruited in this study. In addition to routinely oxytocin, the women in study group will receive TXA 1 g in 2 minutes after they delivered their babies, and those in control group will receive placebo. The incidence of postpartum hemorrhage, the amount of bleeding, as well as the side effects will be observed.

Detailed Description

Not provided

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6,700Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tranexamic acid	Experimental	Tranexamic acid 1 g（10ml） IV in 2 minutes after the baby delivered during ceasarean section	Drug: Tranexamic Acid
placebo	Placebo Comparator	NS 10ml IV in 2 minutes after the baby delivered during ceasarean section	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tranexamic Acid	Drug		Tranexamic acid
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
postpartum hemorrhage		24h after the cesarean section

Secondary Outcomes

Measure	Description	Time Frame
the amount of postpartum bleeding		24h after the cesarean section

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

gestational week more than 37;
to delivery by cesarean section;
informed consent form signed

Exclusion Criteria:

Any known renal or liver disorders
History of venous or arterial thrombosis
Any disease or history tend to increase thrombosis: opertion in 1 month; active smoker.
Do cesarean section because of active bleeding

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014148	Tranexamic Acid

Ancestor Terms

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

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Browse Branches

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