Tranexamic Acid for the Prevention of Postpartum Haemorrhage

Use of Tranexamic Acid for the Prevention of Postpartum Haemorrhage After Cesarean Section in High-risk Patients ( a Randomized Control Trial ).

Use of tranexamic acid (TXA) for the prevention of postpartum haemorrhage (PPH) after cesarean section in high-risk patients ( a randomized control trial ).

Study Overview

• Status: Unknown
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Drug: Tranexamic Acid 100 milligram/Milliliter; Drug: Oxytocin

Detailed Description

Participants will be divided into two groups: a study group & a control group. In addition to the standard management, the study group will be given TXA 1 gm (100 mg/ml) slowly intravenous infusion during delivery after clamping of the cord (administered over 10 minutes at 1 ml/minute).

The second dose of TXA 1 g Intravenous can be given if:

• Bleeding continues after 30 minutes
• Bleeding restarts within 24 hours of completing the first dose While the control group will not be given TXA and we will compare the results in both groups (amount of blood loss during operation to assess efficacy of TXA in prevention of PPH and reduction of intra and postoperative blood loss and to assess its safety and benefit in the reduction of incidence of hysterectomy or blood transfusion requirements).

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Banha
    • Banhā, Banha, Egypt, 13511
      • Recruiting
      • Benha University Hospital
      • Contact: Ahmed A Morad, MD; Phone Number: 0201224214435; Email: awalid217@yahoo.com
      • Principal Investigator: Aboubakr M Elnashar, MD
      • Sub-Investigator: Ahmed A Walid Anwar, MD
      • Sub-Investigator: Ehab E Barakat, MD
    • Banhā, Banha, Egypt, 13511
      • Active, not recruiting
      • Benha University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

Scheduled or unscheduled cesarean delivery. Singleton or twin gestation.

Women at high risk for PPH after cesarean section:

Placenta previa, accreta, increta or percreta. haematocrit (HCT) < 30%. Bleeding at admission. History of Postpartum haemorrhage. Abnormal vital signs (hypotension or tachycardia). Previous Cesarean or uterine surgery. More than four previous deliveries. Multiple Gestation. Large Uterine fibroids. Chorioamnionitis. Magnesium sulphate use. Prolonged use of oxytocin.

Exclusion Criteria:

1. Age less than 18 years.
2. Women who are not at high risk for PPH.
3. Women attending for normal vaginal delivery.
4. Pre-existing maternal hemorrhagic conditions such as Factor 8 deficiency - haemophilia A carrier, Factor 9 deficiency - haemophilia B carrier or Von Willebrand's disease.
5. Recent diagnosis or history of venous thromboembolism or arterial thrombosis because TXA is a risk factor for thromboembolism, and its use is contraindicated.
6. Known congenital or acquired thrombophilias, including antiphospholipid antibody syndrome, because of the increased risk of thrombosis.
7. Autoimmune diseases such as lupus, rheumatoid arthritis, Sjogren's disease, and inflammatory bowel disease because of hypercoagulability and the increased risk of thrombosis or thromboembolism
8. Need for a therapeutic dose of anticoagulation before delivery, because the risk of thrombosis may be increased with TXA.
9. Hypersensitivity to TXA or any of its ingredients.
10. Transfusion or planned transfusion of any blood products during the current admission because the primary outcome is already pre-determined and the need for transfusion will be unrelated to perioperative haemorrhage
11. Seizure disorder (including eclampsia), and its use has been associated with postoperative seizures..
12. Active cancer, because of the risk of thromboembolism.
13. Congestive heart failure requiring treatment, because of the risk of thrombosis.
14. If there is no haemoglobin and hematocrit result available from the last 4 weeks since it is necessary to measure the postoperative change in haemoglobin and hematocrit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: study group will be given tranexamic acid; Participants will be divided into two groups: a study group & a control group. In addition to the standard management, the study group will be given TXA 1 gm (100 mg/ml) slowly intravenous infusion during delivery after clamping of the cord (administered over 10 minutes at 1 ml/minute). The second dose of TXA 1 g Intravenous can be given if: Bleeding continues after 30 minutes; Bleeding restarts within 24 hours of completing the first dose While the control group will not be given TXA and we will compare the results in both groups (amount of blood loss during operation to assess the efficacy of TXA in the prevention of PPH and reduction of intraoperative and postoperative blood loss and to assess its safety and benefit in the reduction of incidence of hysterectomy or blood transfusion requirements).	Drug: Tranexamic Acid 100 milligram/Milliliter; Participants will be divided into two groups: a study group & a control group. In addition to the standard management, the study group will be given TXA 1 gm (100 mg/ml) slowly intravenous infusion during delivery after clamping of the cord (administered over 10 minutes at 1 ml/minute). The second dose of TXA 1 g Intravenous can be given if: Bleeding continues after 30 minutes; Bleeding restarts within 24 hours of completing the first dose While the control group will not be given TXA and we will compare the results in both groups (amount of blood loss during operation to assess the efficacy of TXA in the prevention of PPH and reduction of intraoperative and postoperative blood loss and to assess its safety and benefit in the reduction of incidence of hysterectomy or blood transfusion requirements).; Other Names: Study group; Drug: Oxytocin; both groups will be given oxytocin as a standard management; Other Names: Control group
PLACEBO_COMPARATOR: Control group; The control group will not be given Tranexamic acid but only the standard management ( Oxytocin )	Drug: Oxytocin; both groups will be given oxytocin as a standard management; Other Names: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of blood loss	150 ml/pack	30 minutes after baby delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
transfusion requirements	number of women transfused blood	7 days postpartum
additional medical intervention	number of patients were treated by an additional medical intervention	48 hours postpartum
additional surgical or radiological interventions to control bleeding	number of patients were treated by additional surgical or radiological intervention	7 days postpartum
Change in maternal hematocrit concentration	Hematocrit concentration (Percent)	48 hours postpartum
Tranexamic acid side effects	number of patients suffered from side effects	24 hours postpartum
thromboembolic events	number of patients suffered from thromboembolic events	7 days postpartum
Maternal death	Number of women will die.	7 days postpartum

Collaborators and Investigators

• Sponsor: Benha University
• Investigators: Principal Investigator: Abubaker M Elnashar, MD, Benha Faculty of Medecine

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ANTICIPATED): February 25, 2021
• Study Completion (ANTICIPATED): March 30, 2021

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (ACTUAL): January 13, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: cesarean section; postpartum hemorrhage; Tranexamic acid
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Reproductive Control Agents; Oxytocics; Oxytocin; Tranexamic Acid
• Other Study ID Numbers: SEAbdelfattah

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No