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Completed

NCT Number: NCT04733157

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

This study seeks to determine if the using tranexamic acid prophylactically at caesarean section will prevent postpartum haemorrhage which is a major cause of maternal mortality in Zimbabwe and globally.

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Key information

Conditions

Postpartum Hemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Parirenyatwa Group of Hospitals (Mbuya Nehanda Maternity Hospital), Harare, Zimbabwe

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About this study

This trial will be an placebo-controlled, two-centre, randomized control trial with two parallel groups including 1,162 women who undergo elective or emergency caesarean deliveries at term. The study group will receive tranexamic acid (TXA) 1g intravenously at the onset of skin incision. There is normal saline placebo for the control group. The study and control groups will both receive the standard care offered at caesarean section including 5 IU of oxytocin intravenously on delivery of the baby. .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women undergoing elective or emergency caesarean section with:

  • Estimated gestational age of 37 weeks or more
  • Live intrauterine foetus
  • Elective or emergency caesarean delivery
  • Signed informed consent

Exclusion criteria

  • History of coagulopathies or conditions predisposing them to thromboembolic phenomena,
  • seizure history,
  • autoimmune disease,
  • placental abruption,
  • placenta praevia,
  • abnormally adherent placentae if identified on prenatal ultrasound,
  • eclampsia or HELLP syndrome,
  • known hypersensitivity to TXA,
  • planned general anaesthesia,
  • caesarean delivery for the second twin or second/third triplet(s) after vaginal birth of the first twin,
  • poor understanding of English/Shona languages,
  • those who have received anticoagulants in the week before delivery
  • persons-under-investigation for Coronavirus disease (COVID-19) and confirmed COVID-19 positive women

Treatment and study plan

Tranexamic acid injection

Drug

Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section

Other names: TXA

Normal Saline Placebo

Other

10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group

Primary outcomes

  1. Number of Participants With Postpartum Hemorrhage (PPH)

    Time frame: Up to day 2 postpartum

    Calculated estimated blood loss exceeding 1000ml. Estimated Blood Loss (EBL) was calculated using laboratory values of hemoglobin levels before and after procedure. Postpartum hemorrhage is defined as blood loss exceeding 1000mL after cesarean section.

Secondary outcomes

  1. Blood Loss Using Hemoglobin Values

    Time frame: Up to day 2 postpartum

    Calculated blood loss using hemoglobin values. A mean value of blood loss calculated using hemoglobin values

  2. Mean Blood Loss as Estimated by Obstetrician

    Time frame: 2 hours

    Visually estimated blood loss at time of caesarean section. Attending obstetrician gave an estimated value of blood loss after delivery.

  3. Occurrence of Postpartum Shock

    Time frame: Up to day 2 postpartum

    Number of participants who had hypovolemic shock related to PPH as determined by assessing BP and pulse.

  4. Use of Supplementary Uterotonic(s)

    Time frame: Up to day 2 postpartum

    Number of women requiring supplementary uterotonics

  5. Postpartum Transfusion

    Time frame: Up to day 2 postpartum

    Number of women given postpartum transfusion

  6. Emergency Surgery for PPH

    Time frame: Up to day 2 postpartum

    Number of participants who had emergency surgery for PPH including caesarean hysterectomies

  7. Change in Peripartum Haemoglobin

    Time frame: Up to day 2 postpartum

    Mean change in haemoglobin concentration between the study group, calculated hemoglobin values at day 2 postpartum minus baseline hemoglobin values.

  8. Number of Participants With a Decrease in Peripartum Hemoglobin

    Time frame: Up to day 2 postpartum

    Number of participants with a drop in hemoglobin more than 2g/dL or less than 2g/dL

  9. Change in Peripartum Haematocrit

    Time frame: Up to day 2 postpartum

    Mean change in haematocrit percentage between the study groups from baseline to day 2 postpartum

  10. Admission Into Intensive Care Unit

    Time frame: Up to day 2 postpartum

    Number of participants transferred to intensive care unit

  11. Death From Any Cause

    Time frame: Up to date of death or day 4 from admission

    Number of participants who died from any cause

  12. Blood Pressure Measurements

    Time frame: Up to 2 hours after the caesarean section

    Blood pressure at 15, 30, 45, 60, and 120 min after delivery

  13. Number of Mild Adverse Events

    Time frame: Up to 24 hours after administration

    Number of mild events of nausea, vomiting, sensation of rings or spots of light in the visual field, dizziness

  14. Number of Severe Adverse Events

    Time frame: Up to day 3 postpartum

    • Deep vein thrombosis (if the diagnosis is confirmed by Doppler ultrasound)
    • Pulmonary embolism (if the diagnosis is confirmed by radiological examination)
    • Myocardial infarction
    • Seizure
    • Renal failure requiring dialysis

  15. Any Other Unexpected Adverse Event

    Time frame: Up to day 3 postpartum

    Number of unexpected events during and after the adminstration of study drug and duration of observation

  16. Length of Hospital Stay

    Time frame: Up to day 3 postpartum

    Duration of hospital admission in days

Sponsors and collaborators

Lead sponsor

University of Zimbabwe

Other

Collaborators

  • Fogarty International Center of the National Institute of Health

Registry information

Acronym: ETAPPH

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 1, 2021
Registry last updated
Mar 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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