tranexamic acid and Maternal Death

tranexamic acid has been researched along with Maternal Death in 7 studies

Tranexamic Acid: Antifibrinolytic hemostatic used in severe hemorrhage.

Maternal Death: The death of the female parent.

Research

Studies (7)

Authors

Clinical Trials (7)

Trial Overview

Trial Outcomes

Change in Hemoglobin

[Key secondary outcome] Change in hemoglobin from the most recent measured before delivery to lowest measured in the 48 hours after delivery (NCT03364491)
Timeframe: from 4 weeks before delivery to 48 hours postpartum

Length of Stay

Mother's length of stay from delivery to discharge (NCT03364491)
Timeframe: Until hospital discharge, an average of 3 days

Number of Mothers Who Died or Had Thromboembolic Events (Venous or Arterial), Ischemic Stroke, Myocardial Infarction, New-onset Seizure Activity, or Were Admitted to the Intensive Care Unit for More Than 24 Hours

(NCT03364491)
Timeframe: within 6 weeks postpartum

Number of Participants Who Received Open Label TXA or Other Antifibrinolytic

This is the number of mothers who were treated with any amount of open-label TXA (not blinded study drug) or another antifibrinolytic (eg., Amicar) (NCT03364491)
Timeframe: within 7 days postpartum

Number of Participants Who Received Surgical or Radiologic Interventions to Control Bleeding and Related Complications

This is the number of mothers who required any of the following types of surgical procedures to control bleeding: laparotomy, evacuation of hematoma, hysterectomy, uterine packing, intrauterine balloon tamponade, interventional radiology (NCT03364491)
Timeframe: within 7 days postpartum

Number of Participants Who Received Treatments and Interventions in Response to Bleeding and Related Complications

[Key secondary outcome] This is the number of mothers who received treatments and interventions to control bleeding such as: uterotonics such as prostaglandins or methergine, but excluding oxytocin; open label TXA or other antifibrinolytics; transfusion of 1 or more units of fresh frozen plasma, cryoprecipitate, or platelets or administration of any factor concentrates; laparotomy, evacuation of hematoma, hysterectomy, uterine packing, intrauterine balloon tamponade, interventional radiology (NCT03364491)
Timeframe: within 7 days postpartum

Number of Participants Who Were Transfused With 4 or More Units of Packed Red Blood Cells

Participants were categorized according to the amount of packed red blood cells or whole blood transfused, either as 0 to 3 units, or 4 or more units (NCT03364491)
Timeframe: within 7 days postpartum

Number of Participants Who Were Transfused With Other Blood Products

This is the number of mothers who received during the first 7 days after delivery a transfusion of 1 or more units of fresh frozen plasma, cryoprecipitate, or platelets, or received any factor concentrates (NCT03364491)
Timeframe: within 7 days postpartum

Number of Participants Who Were Treated With Uterotonics Other Than Oxytocin

This is the number of mothers who were treated with uterotonics such as prostaglandins or methergine, but excluding oxytocin, from delivery through 48 hours after delivery. (NCT03364491)
Timeframe: within 48 hours postpartum

Number of Participants With a Thromboembolic Event (Venous or Arterial), Ischemic Stroke, or Myocardial Infarction

[Key secondary outcome] This is the number of mothers who experienced a thromboembolic event, ischemic stroke, or myocardial infarction during the 6 weeks after delivery. (NCT03364491)
Timeframe: within 6 weeks postpartum

Number of Participants With Estimated Blood Loss Greater Than 1 Liter During Delivery

[Major secondary outcome] The surgeon or anesthesiologist estimated the blood loss during the delivery in milliliters, which was recorded in the anesthesia record and/or operative report (NCT03364491)
Timeframe: From skin incision to transfer from operating room, average of 1 hour

Number of Participants With Maternal Death or Transfusion of Packed Red Blood Cells

Participants were monitored from delivery until hospital discharge or 7 days after delivery (postpartum), whichever is sooner. This is the number of mothers who died for any reason, or had a blood transfusion of 1 or more units (of packed red blood cells, including whole blood or cell saver). (NCT03364491)
Timeframe: by hospital discharge or by 7 days postpartum, whichever is sooner

Number of Participants With Postpartum Infectious Complications

[Key Secondary Outcome] This is the number of mothers who experienced any of the following infectious complications in the 6 weeks after delivery: endometritis, surgical site infection, pelvic abscess (NCT03364491)
Timeframe: within 6 weeks postpartum

Number of Participants With Seizure Activity That Was Not Seen Prior to Study Enrollment

This is the number of mothers who experienced seizure activity, confirmed by central review, whose onset is after enrollment (NCT03364491)
Timeframe: within 6 weeks postpartum

Blood Volume Loss

Total blood volume loss will be calculated in milliliters. (NCT03856164)
Timeframe: 24 hours postpartum.

D-Dimer (µg/mL)

Measured from blood sample collection. (NCT03856164)
Timeframe: Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.

Fibrinogen (mg/dL)

Measured from blood sample collection. (NCT03856164)
Timeframe: Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.

Plasminogen Activator Inhibitor-Type-1 (Units/mL)

Measured from blood sample collection. (NCT03856164)
Timeframe: Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.

Rotational Thromboelastometry INTEM and EXTEM Clotting Time

Rotational thromboelastometry is a whole blood viscoelastic test that analyzes deficits in clotting factors, clot strength, and clot breakdown. EXTEM, INTEM, and FIBTEM tests measure the extrinsic pathway, intrinsic pathway, and fibrinogen levels, respectively. Compared to non-pregnant patients, FIBTEM/EXTEM/INTEM amplitudes and the FIBTEM maximum clot firmness are higher in pregnant women. The EXTEM and INTEM clotting time are shorter, indicating the relative hypercoagulability of pregnancy. Reference ranges for INTEM Clotting Time (100-240 seconds), INTEM Maximum Clot Firmness (50-72 millimeter), EXTEM Clotting Time (38-79 seconds), EXTEM Maximum Clot Firmness (50-72 millimeter), FIBTEM Maximum Clot Firmness (9-25 millimeter). (NCT03856164)
Timeframe: Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.

Rotational Thromboelastometry INTEM, EXTEM, FIBTEM Maximum Clot Firmness

Rotational thromboelastometry is a whole blood viscoelastic test that analyzes deficits in clotting factors, clot strength, and clot breakdown. EXTEM, INTEM, and FIBTEM tests measure the extrinsic pathway, intrinsic pathway, and fibrinogen levels, respectively. Compared to non-pregnant patients, FIBTEM/EXTEM/INTEM amplitudes and the FIBTEM maximum clot firmness are higher in pregnant women. The EXTEM and INTEM clotting time are shorter, indicating the relative hypercoagulability of pregnancy. Reference ranges for INTEM Clotting Time (100-240 seconds), INTEM Maximum Clot Firmness (50-72 millimeter), EXTEM Clotting Time (38-79 seconds), EXTEM Maximum Clot Firmness (50-72 millimeter), FIBTEM Maximum Clot Firmness (9-25 millimeter). (NCT03856164)
Timeframe: Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.

Tissue Plasminogen Activator Antigen (ng/mL)

Measured from blood sample collection. (NCT03856164)
Timeframe: Collection prior to first drug infusion, immediately before second infusion and 24 hours postpartum.

Reviews

1 review available for tranexamic acid and Maternal Death

Trials

3 trials available for tranexamic acid and Maternal Death

Other Studies

3 other studies available for tranexamic acid and Maternal Death