NCT02936661

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6,700

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

1.7 years

First QC Date

October 15, 2016

Last Update Submit

October 17, 2016

Conditions

Postpartum Hemorrhage， Cesarean Section

Keywords

postpartum hemorrhage， cesarean section， tranexamic acid

Outcome Measures

Primary Outcomes (1)

  • postpartum hemorrhage

    24h after the cesarean section

Secondary Outcomes (1)

  • the amount of postpartum bleeding

    24h after the cesarean section

Study Arms (2)

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

Tranexamic AcidDRUG
Tranexamic acid
PlaceboDRUG
placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2016

First Posted

October 18, 2016

Study Start

April 1, 2017

Primary Completion

December 1, 2018

Study Completion

March 1, 2019

Last Updated

October 18, 2016

Record last verified: 2016-10