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Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Elective Caesarean Section

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ClinicalTrials.gov Identifier: NCT03463993
Recruitment Status : Active, not recruiting
First Posted : March 13, 2018
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Chipo Gwanzura, MD, University of Zimbabwe

Brief Summary:

Background Postpartum haemorrhage (PPH) is a major cause of maternal mortality worldwide accounting for 25% of maternal deaths. In Zimbabwe PPH is the second most common cause of death. Tranexamic acid (TXA) is widely used to reduce blood loss in elective surgery, bleeding trauma patients, and menorrhagia.

The investigators seek to determine the efficacy of TXA in reducing PPH during and after elective caesarean section.

Methods and Design The investigators intend to perform an open label randomized control study of 1,162 women who are undergoing elective caesarean section. The participants will be randomly selected to receive an intravenous infusion of TXA 10 minutes prior to skin incision or not to receive the intervention. Prophylactic oxytocin will be administered to all the women.

The primary outcome will be incidence of PPH defined by blood loss equal to or more than 1,000ml calculated by determining the difference in haematocrit values taken prior to and 48 hours after caesarean section.

Discussion In addition to prophylactic uterotonic administration, TXA is a complementary component acting on the haemostatic process that can be used in the third stage of labour to prevent PPH. It is a promising intervention that is cheap, easy to administer and would be easy to add to routine delivery protocols in hospitals. It would also help to conserve precious resources by reducing the need for blood products, and expensive surgical interventions to manage PPH.

This large adequately powered randomized study seeks to determine the efficacy of TXA to validate its routine use at caesarean section to prevent PPH.


Condition or disease Intervention/treatment Phase
Post Partum Hemorrhage Drug: Tranexamic Acid Drug: Oxytocin Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized control trial with two arms. Participants receive either 10mg/kg of TXA 10 minutes prior to elective caesarean section with prophylactic oxytocin administration after delivery of the baby, versus prophylactic oxytocin alone after delivery of the baby.
Masking: None (Open Label)
Masking Description: Trial is an open label randomized control trial
Primary Purpose: Prevention
Official Title: Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Elective Caesarean Section
Actual Study Start Date : April 8, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A
Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby.
Drug: Tranexamic Acid
TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision.
Other Name: TXA

Drug: Oxytocin
5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.
Other Name: Prophylactic oxytocin

Active Comparator: Group B
Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby
Drug: Oxytocin
5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.
Other Name: Prophylactic oxytocin




Primary Outcome Measures :
  1. Incidence of PPH [ Time Frame: Up to 48 hours post-caesarean section ]
    Blood loss equal to or exceeding 1000ml following elective caesarean section


Secondary Outcome Measures :
  1. Estimated blood loss [ Time Frame: At caesarean section ]
    Blood loss during caesarean section based on visual estimation and calculation.

  2. Need for blood transfusion [ Time Frame: At caesarean section up to 48 hours post-caesarean section ]
    Requirement by participant of blood transfusion

  3. Use of additional uterotonics [ Time Frame: At caesarean section up to 48 hours post-caesarean section ]
    Use of additional uterotonics such as an oxytocin infusion or prostaglandin use

  4. Tranexamic acid side effects [ Time Frame: From intravenous infusion of the drug up to 48 hours post-caesarean section ]
    Any adverse effects related to tranexamic acid use

  5. Incidence of emergency surgery for postpartum haemorrhage [ Time Frame: At caesarean section up to 48 hours post-caesarean section ]
    Incidence of emergency surgical procedures to manage any postpartum haemorrhage that occurs

  6. Duration of participants' hospital stay [ Time Frame: From date of randomization until the day 2 post-caesarean section (date of discharge from hospital) or date of death whichever comes earlier ]
    Duration of participants' stay in hospital

  7. Neonatal outcome - weight [ Time Frame: From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier ]
    Birth weight in grams

  8. Neonatal outcome - Apgar scores [ Time Frame: Scores at 1 minute from time of delivery and at 5 minutes after delivery ]
    Apgar scores out of 10 at 1 minute and 5 minute

  9. Neonatal outcome - admission to neonatal unit [ Time Frame: From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier ]
    Reason for and number of days from admission to and duration of stay in neonatal unit

  10. Neonatal outcome - jaundice [ Time Frame: From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier ]
    Clinical presence of neonatal jaundice

  11. Neonatal outcome - thromboembolic event [ Time Frame: From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier ]
    Number of neonatal thromboembolic events

  12. Neonatal outcome - death [ Time Frame: From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier ]
    Neonatal death that occurs



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant woman with signed informed consent***
  • Understand English and/or Shona
  • Estimated gestational age of 38 weeks or older
  • Requiring Elective Caesarean Section defined as caesarean section performed before onset of labour
  • Live intrauterine fetus

    • The study will enrol participants who are Pregnant and who have a signed informed Consent form. Some of the pregnant women may be minors as they are occasionally included in patients planned for elective caesarean section for varying indications. Their inclusion also will make the results of the trial generalizable to elective caesarean section patients attended to at the two study hospitals. Consent will be sought from a legally authorized representative such as the parent or guardian.

Exclusion Criteria:

  • Placental Abruption
  • Emergency caesarean section
  • Current or previous history of significant disease including heart disease, liver, renal disorders
  • Known coagulopathy or history of deep venous thrombosis and/or pulmonary embolism, or arterial thrombosis (angina pectoris, myocardial infarction, stroke)
  • History of epilepsy or seizures
  • Autoimmune disease
  • Sickle cell disease
  • Severe haemorrhagic disease
  • Intrauterine fetal demise
  • Eclampsia/HELLP syndrome
  • Administration of anticoagulants - clexane or antiplatelet agents in the week prior to delivery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03463993


Locations
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Zimbabwe
Harare Central Hospital
Harare, Zimbabwe
Parirenyatwa Group of Hospitals
Harare, Zimbabwe
Sponsors and Collaborators
University of Zimbabwe
Investigators
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Study Chair: Tsungai Chipato, MBChB FRCOG Professor of Obstetrics and Gynaecology
Study Chair: Taazadza Nhemachena, MBChB MMED Lecturer and Consultant
Principal Investigator: Chipo Gwanzura, MBChB Registrar

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Responsible Party: Chipo Gwanzura, MD, Junior Registrar, University of Zimbabwe
ClinicalTrials.gov Identifier: NCT03463993     History of Changes
Other Study ID Numbers: ETAPPPH
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is undecided whether the IPD will be made available to other researchers. Clearance is required first from ethical bodies and supervisors

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Puerperal Disorders
Uterine Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Tranexamic Acid
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants