Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 30 of 618 for:    Hemorrhage AND postpartum

Tranexamic Acid for Preventing Postpartum Hemorrhage After Cesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02936661
Recruitment Status : Unknown
Verified October 2016 by Shanghai First Maternity and Infant Hospital.
Recruitment status was:  Not yet recruiting
First Posted : October 18, 2016
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Shanghai First Maternity and Infant Hospital

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.

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage, Cesarean Section Drug: Tranexamic Acid Drug: Placebo Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : April 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. postpartum hemorrhage [ Time Frame: 24h after the cesarean section ]

Secondary Outcome Measures :
  1. the amount of postpartum bleeding [ Time Frame: 24h after the cesarean section ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Layout table for additonal information
Responsible Party: Shanghai First Maternity and Infant Hospital
ClinicalTrials.gov Identifier: NCT02936661     History of Changes
Other Study ID Numbers: ShanghaiFMIH-TXA1
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Shanghai First Maternity and Infant Hospital:
postpartum hemorrhage, cesarean section, tranexamic acid

Additional relevant MeSH terms:
Layout table for MeSH terms
Hemorrhage
Postpartum Hemorrhage
Puerperal Disorders
Uterine Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants