Tranexamic Acid for Preventing Postpartum Hemorrhage After Cesarean Section

October 17, 2016 updated by: Shanghai First Maternity and Infant Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

6700

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tranexamic acid
Tranexamic acid 1 g（10ml） IV in 2 minutes after the baby delivered during ceasarean section
Drug: Tranexamic Acid
Placebo Comparator: placebo
NS 10ml IV in 2 minutes after the baby delivered during ceasarean section
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postpartum hemorrhage
Time Frame: 24h after the cesarean section
24h after the cesarean section

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai First Maternity and Infant Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2017

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

October 15, 2016

First Submitted That Met QC Criteria

October 17, 2016

First Posted (Estimate)

October 18, 2016

Study Record Updates

Last Update Posted (Estimate)

October 18, 2016

Last Update Submitted That Met QC Criteria

October 17, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShanghaiFMIH-TXA1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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