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Tranexamic Acid for the Prevention of Postpartum Haemorrhage

Primary Purpose

Postpartum Hemorrhage

Status

Unknown status

Phase

Phase 1

Locations

Egypt

Study Type

Interventional

Intervention

Tranexamic Acid 100 milligram/Milliliter

Oxytocin

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage focused on measuring Tranexamic acid, postpartum hemorrhage, cesarean section

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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:

Age less than 18 years.
Women who are not at high risk for PPH.
Women attending for normal vaginal delivery.
Pre-existing maternal hemorrhagic conditions such as Factor 8 deficiency - haemophilia A carrier, Factor 9 deficiency - haemophilia B carrier or Von Willebrand's disease.
Recent diagnosis or history of venous thromboembolism or arterial thrombosis because TXA is a risk factor for thromboembolism, and its use is contraindicated.
Known congenital or acquired thrombophilias, including antiphospholipid antibody syndrome, because of the increased risk of thrombosis.
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
Need for a therapeutic dose of anticoagulation before delivery, because the risk of thrombosis may be increased with TXA.
Hypersensitivity to TXA or any of its ingredients.
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
Seizure disorder (including eclampsia), and its use has been associated with postoperative seizures..
Active cancer, because of the risk of thromboembolism.
Congestive heart failure requiring treatment, because of the risk of thrombosis.
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.

Sites / Locations

Benha university hospitalRecruiting
Benha University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

study group will be given tranexamic acid

Control group

Arm 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 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).

The control group will not be given Tranexamic acid but only the standard management ( Oxytocin )

Outcomes

Primary Outcome Measures

Volume of blood loss

150 ml/pack

Secondary Outcome Measures

transfusion requirements

number of women transfused blood

additional medical intervention

number of patients were treated by an additional medical intervention

additional surgical or radiological interventions to control bleeding

number of patients were treated by additional surgical or radiological intervention

Change in maternal hematocrit concentration

Hematocrit concentration (Percent)

Tranexamic acid side effects

number of patients suffered from side effects

thromboembolic events

number of patients suffered from thromboembolic events

Maternal death

Number of women will die.

Full Information

NCT ID

NCT04707950

First Posted

February 25, 2020

Last Updated

January 11, 2021

Sponsor

Benha University

1. Study Identification

Unique Protocol Identification Number

NCT04707950

Brief Title

Tranexamic Acid for the Prevention of Postpartum Haemorrhage

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2020 (Actual)

Primary Completion Date

February 25, 2021 (Anticipated)

Study Completion Date

March 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Benha University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postpartum Hemorrhage

Keywords

Tranexamic acid, postpartum hemorrhage, cesarean section

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

study group will be given tranexamic acid

Arm Type

Active Comparator

Arm Description

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

The control group will not be given Tranexamic acid but only the standard management ( Oxytocin )

Intervention Type

Drug

Intervention Name(s)

Tranexamic Acid 100 milligram/Milliliter

Other Intervention Name(s)

Study group

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Oxytocin

Other Intervention Name(s)

Control group

Intervention Description

both groups will be given oxytocin as a standard management

Primary Outcome Measure Information:

Title

Volume of blood loss

Description

150 ml/pack

Time Frame

30 minutes after baby delivery

Secondary Outcome Measure Information:

Title

transfusion requirements

Description

number of women transfused blood

Time Frame

7 days postpartum

Title

additional medical intervention

Description

number of patients were treated by an additional medical intervention

Time Frame

48 hours postpartum

Title

additional surgical or radiological interventions to control bleeding

Description

number of patients were treated by additional surgical or radiological intervention

Time Frame

7 days postpartum

Title

Change in maternal hematocrit concentration

Description

Hematocrit concentration (Percent)

Time Frame

48 hours postpartum

Title

Tranexamic acid side effects

Description

number of patients suffered from side effects

Time Frame

24 hours postpartum

Title

thromboembolic events

Description

number of patients suffered from thromboembolic events

Time Frame

7 days postpartum

Title

Maternal death

Description

Number of women will die.

Time Frame

7 days postpartum

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

women with high risk for postpsrtum hemorrhage after ceserean section

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: Age less than 18 years. Women who are not at high risk for PPH. Women attending for normal vaginal delivery. Pre-existing maternal hemorrhagic conditions such as Factor 8 deficiency - haemophilia A carrier, Factor 9 deficiency - haemophilia B carrier or Von Willebrand's disease. Recent diagnosis or history of venous thromboembolism or arterial thrombosis because TXA is a risk factor for thromboembolism, and its use is contraindicated. Known congenital or acquired thrombophilias, including antiphospholipid antibody syndrome, because of the increased risk of thrombosis. 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 Need for a therapeutic dose of anticoagulation before delivery, because the risk of thrombosis may be increased with TXA. Hypersensitivity to TXA or any of its ingredients. 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 Seizure disorder (including eclampsia), and its use has been associated with postoperative seizures.. Active cancer, because of the risk of thromboembolism. Congestive heart failure requiring treatment, because of the risk of thrombosis. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ahmed A Morad, MD

Phone

0201224214435

awalid217@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Abubaker M Elnashar, MD

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Abubaker M Elnashar, MD

Organizational Affiliation

Benha Faculty of Medecine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Benha university hospital

City

Banhā

State/Province

Banha

ZIP/Postal Code

13511

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ahmed A Morad, MD

Phone

0201224214435

awalid217@yahoo.com

First Name & Middle Initial & Last Name & Degree

Aboubakr M Elnashar, MD

First Name & Middle Initial & Last Name & Degree

Ahmed A Walid Anwar, MD

First Name & Middle Initial & Last Name & Degree

Ehab E Barakat, MD

Facility Name

Benha University

City

Banhā

State/Province

Banha

ZIP/Postal Code

13511

Country

Egypt

Individual Site Status

Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD

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Tranexamic Acid for the Prevention of Postpartum Haemorrhage

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