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

Primary Purpose

Post Partum Hemorrhage

Status
Completed
Phase
Phase 4
Locations
Tunisia
Study Type
Interventional
Intervention
Tranexamic Acid
saline serum
Sponsored by
Hédi Chaker Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Partum Hemorrhage focused on measuring post partum hemorrhage, transfusion, tranexamic acid

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hedi Chaker University Hospital of Sfax, Department of Anesthesiology and Intensive Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

tranexamic acid, post partum hemorrhage

placebo

Arm Description

Outcomes

Primary Outcome Measures

volume blood loss

Secondary Outcome Measures

transfusion rates.

Full Information

First Posted
May 14, 2012
Last Updated
May 21, 2012
Sponsor
Hédi Chaker Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01599468
Brief Title
Can Tranexamic Acid Reduce Bleeding After Post Partum Hemorrhage in Cesarean Section Delivery
Official Title
Effects of Tranexamic Acid on Post Partum Hemorrhage by Uterine Atony After Cesarean Section Delivery: a Randomized, Placebo Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hédi Chaker Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Partum Hemorrhage
Keywords
post partum hemorrhage, transfusion, tranexamic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tranexamic acid, post partum hemorrhage
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
exacyl
Intervention Description
10 mg/kg of tranexamic acid as induction dose within 12 minutes and 1mg/Kg/h as maintenance within the 2 following hours
Intervention Type
Drug
Intervention Name(s)
saline serum
Other Intervention Name(s)
normal saline; NaCl 0.9%
Intervention Description
The Placebo group received normal saline with the same volumes
Primary Outcome Measure Information:
Title
volume blood loss
Time Frame
within 5 days after delivery
Secondary Outcome Measure Information:
Title
transfusion rates.
Time Frame
within 5 days after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohamed ayedi
Organizational Affiliation
hedi chaker university hospital of sfax, tunisia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hedi Chaker University Hospital of Sfax, Department of Anesthesiology and Intensive Care
City
Sfax
ZIP/Postal Code
3029
Country
Tunisia

12. IPD Sharing Statement

Citations:
PubMed Identifier
21496253
Citation
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.
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Can Tranexamic Acid Reduce Bleeding After Post Partum Hemorrhage in Cesarean Section Delivery

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