Tranexamic Acid for the Prevention of Postpartum Haemorrhage

NCT04707950 | Unknown Phase 1 DMC

• 1 other identifier: SEAbdelfattah
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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 ).

Conditions

Postpartum Hemorrhage

Keywords

Tranexamic acid; postpartum hemorrhage; cesarean section

Outcome Measures

Primary Outcomes (1)

• Volume of blood loss

  150 ml/pack

  30 minutes after baby delivery

Secondary Outcomes (7)

• transfusion requirements

  7 days postpartum

• additional medical intervention

  48 hours postpartum

• additional surgical or radiological interventions to control bleeding

  7 days postpartum

• Change in maternal hematocrit concentration

  48 hours postpartum

• Tranexamic acid side effects

  24 hours postpartum

Study Arms (2)

study group will be given tranexamic acid

ACTIVE COMPARATOR

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; Drug: Oxytocin

Control group

PLACEBO COMPARATOR

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

Drug: Oxytocin

Interventions

Tranexamic Acid 100 milligram/Milliliter DRUG

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).

Also known as: Study group

study group will be given tranexamic acid

Oxytocin DRUG

both groups will be given oxytocin as a standard management

Also known as: Control group

Control group; study group will be given tranexamic acid

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: women with high risk for postpsrtum hemorrhage after ceserean section
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (2)

Benha university hospital

Banhā, Banha, 13511, Egypt

RECRUITING

Benha University

Banhā, Banha, 13511, Egypt

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Oxytocin; Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Abubaker M Elnashar, MD

  Benha Faculty of Medecine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed A Morad, MD

CONTACT

0201224214435; awalid217@yahoo.com

Abubaker M Elnashar, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: January 13, 2021
• Study Start: January 1, 2020
• Primary Completion: February 25, 2021
• Study Completion: March 30, 2021
• Last Updated: January 13, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)