Can Tranexamic Acid Reduce Bleeding After Post Partum Hemorrhage in Cesarean Section Delivery

Post Partum Hemorrhage Clinical Trial

Official title:

Effects of Tranexamic Acid on Post Partum Hemorrhage by Uterine Atony After Cesarean Section Delivery: a Randomized, Placebo Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01599468
• Other study ID #: TXA-1
• Status: Completed
• Phase: Phase 4
• First received: May 14, 2012
• Last updated: May 21, 2012
• Start date: July 2011
• Est. completion date: April 2012

Study information

• Verified date: May 2012
• Source: Hédi Chaker Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tunisia: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to evaluate the effect of early administration of tranexamic acid (TXA) on post partum hemorrhage caused by uterine atony after cesarean section delivery.

This was a randomised, placebo controlled trial including 74 patients. The investigators included ASA1 parturients with correct haemostatic status undergoing cesarean section under spinal anesthesia. The randomization begins after the inefficacy of oxytocin injections and starting up sulprostone perfusion at the request of the surgeon. TXA Group received 10 mg/kg of tranexamic acid as induction dose within 12 minutes and 1mg/Kg/h as maintenance within the 2 following hours. Placebo Group received same volumes of normal saline. The investigators compared blood loss and transfusions in both groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• ASA1 parturients

• aged from 20 to 40

• correct preoperative haemostatic status (prothrombine ratio > 60 % and platelet rate > 100 000),

• cesarean section under spinal anesthesia complicated by uterine atony needing the introduction of Sulprostone

Exclusion Criteria:

• abnormal placentation

• severe pre-eclampsia

• coagulopathy and uterine rupture

• the contra indications of TXA : past history of vascular occlusive event, convulsion, and allergy.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Post Partum Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Tranexamic Acid
10 mg/kg of tranexamic acid as induction dose within 12 minutes and 1mg/Kg/h as maintenance within the 2 following hours
• saline serum
The Placebo group received normal saline with the same volumes

Locations

Country	Name	City	State
Tunisia	Hedi Chaker University Hospital of Sfax, Department of Anesthesiology and Intensive Care	Sfax

Sponsors (1)

Lead Sponsor	Collaborator
Hédi Chaker Hospital

Country where clinical trial is conducted

Tunisia, 

References & Publications (1)

Ducloy-Bouthors AS, Jude B, Duhamel A, Broisin F, Huissoud C, Keita-Meyer H, Mandelbrot L, Tillouche N, Fontaine S, Le Goueff F, Depret-Mosser S, Vallet B; EXADELI Study Group, Susen S. High-dose tranexamic acid reduces blood loss in postpartum haemorrhage. Crit Care. 2011;15(2):R117. doi: 10.1186/cc10143. Epub 2011 Apr 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	volume blood loss		within 5 days after delivery	Yes
Secondary	transfusion rates.		within 5 days after delivery	Yes