Tranexamic Acid for Preventing Postpartum Hemorrhage After Cesarean Section

• Sponsor: Shanghai First Maternity and Infant Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02936661
• Collaborator: (none)
• Enrollment: 6,700
• Arms: 2
• Duration (Months): 23

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 6700 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Study Start Date: Apr 1, 2017
• Anticipated Primary Completion Date: Dec 1, 2018
• Anticipated Study Completion Date: Mar 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. postpartum hemorrhage [24h after the cesarean section]

Secondary Outcome Measures

1. the amount of postpartum bleeding [24h after the cesarean section]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Shanghai First Maternity and Infant Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai First Maternity and Infant Hospital
• ClinicalTrials.gov Identifier: NCT02936661
• Other Study ID Numbers: ShanghaiFMIH-TXA1
• First Posted: Oct 18, 2016
• Last Update Posted: Oct 18, 2016
• Last Verified: Oct 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Shanghai First Maternity and Infant Hospital: postpartum hemorrhage， cesarean section， tranexamic acid
• Additional relevant MeSH terms: Postpartum Hemorrhage; Hemorrhage; Tranexamic Acid

Study Results

No Results Posted as of Oct 18, 2016