tranexamic acid and Complications, Pregnancy studies

Research Excerpts

Excerpt	Relevance	Reference
" We sought to determine the impact of tranexamic acid and ɛ-aminocaproic acid on in vitro clotting properties in pregnancy."	3.85	Using antifibrinolytics in the peripartum period - concern for a hypercoagulable effect? ( Ahmadzia, HK; Grotegut, CA; Hoffman, MR; James, AH; Lockhart, EL; Murtha, AP; Swamy, GK; Thomas, SM; Welsby, IJ, 2017)
" A rapid recourse to prostaglandins (sulprostone in France) may reverse uterine atony."	3.83	Major obstetric hemorrhage. ( Le Gouez, A; Mercier, FJ, 2016)
"Hereditary angioneurotic edema (HAE) is an autosomal dominant disease caused by a deficiency of a complement regulatory protein, the C1INH."	2.38	[Clinical contribution to the problem of correlations between hereditary angioneurotic edema and pregnancy]. ( Barrile, A; Bonanno, D; Crisafi, A; Ferlazzo, B; Ferrari, U; Quattrocchi, P; Sorge, R, 1990)
"The authors describe a case of immune thrombocytopenic purpura presenting with spontaneous gingival haemorrhage in pregnancy."	1.51	Immune thrombocytopenic purpura presenting with spontaneous gingival haemorrhage in pregnancy. ( Dunphy, L; Williams, R, 2019)
"Anaphylaxis during pregnancy is rare but life threatening to both mother and fetus."	1.42	Anaphylaxis-induced hyperfibrinolysis in pregnancy. ( Browning, RM; Truong, HT, 2015)

Research

Studies (9)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

Change in Hemoglobin

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	1 (11.11)	18.2507
2000's	3 (33.33)	29.6817
2010's	5 (55.56)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Dunphy, L	1
Williams, R	1
Truong, HT	1
Browning, RM	1
Le Gouez, A	1
Mercier, FJ	1
Ahmadzia, HK	1
Lockhart, EL	1
Thomas, SM	1
Welsby, IJ	1
Hoffman, MR	1
James, AH	1
Murtha, AP	1
Swamy, GK	1
Grotegut, CA	1
Riddell, A	1
Abdul-Kadir, R	1
Pollard, D	1
Tuddenham, E	1
Gomez, K	1
Carradice, D	1
Austin, N	1
Bayston, K	1
Ganly, PS	1
Bouillet, L	1
Ponard, D	1
Rousset, H	1
Cichon, S	1
Drouet, C	1
Fiz Matías, J	1
Ferrer Cerón, SM	1
García Pérez, C	1
Marcos Vidal, JM	1
Ferlazzo, B	1
Barrile, A	1
Bonanno, D	1
Crisafi, A	1
Ferrari, U	1
Quattrocchi, P	1
Sorge, R	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean Delivery: A Randomized Controlled Trial[NCT03364491]	Phase 3	11,000 participants (Actual)	Interventional	2018-03-15	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

[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

Intervention	grams per deciliter (Mean)
Tranexamic Acid	-1.8
Placebo	-1.9

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

Number of Participants Who Received Open Label TXA or Other Antifibrinolytic

Intervention	days (Median)
Tranexamic Acid	3
Placebo	3

Intervention	Participants (Count of Participants)
Tranexamic Acid	35
Placebo	32

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

Intervention	Participants (Count of Participants)
Tranexamic Acid	108
Placebo	109

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

Intervention	Participants (Count of Participants)
Tranexamic Acid	233
Placebo	231

[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

Intervention	Participants (Count of Participants)
Tranexamic Acid	892
Placebo	986

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

Intervention	Participants (Count of Participants)
Tranexamic Acid	20
Placebo	19

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

Intervention	Participants (Count of Participants)
Tranexamic Acid	29
Placebo	31

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

Intervention	Participants (Count of Participants)
Tranexamic Acid	649
Placebo	732

[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

Intervention	Participants (Count of Participants)
Tranexamic Acid	12
Placebo	13

[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

Intervention	Participants (Count of Participants)
Tranexamic Acid	339
Placebo	368

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

Intervention	Participants (Count of Participants)
Tranexamic Acid	201
Placebo	233

[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

Intervention	Participants (Count of Participants)
Tranexamic Acid	162
Placebo	125

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

Article	Year
Immune thrombocytopenic purpura presenting with spontaneous gingival haemorrhage in pregnancy. BMJ case reports, 2019, Jan-17, Volume: 12, Issue:1 Topics: Adult; Female; Gingival Hemorrhage; Humans; Immunoglobulins, Intravenous; Pregnancy; Pregnancy Compl	2019
Anaphylaxis-induced hyperfibrinolysis in pregnancy. International journal of obstetric anesthesia, 2015, Volume: 24, Issue:2 Topics: Adult; Anaphylaxis; Antifibrinolytic Agents; Blood Coagulation Disorders; Bronchial Spasm; Crystallo	2015
Major obstetric hemorrhage. Transfusion clinique et biologique : journal de la Societe francaise de transfusion sanguine, 2016, Volume: 23, Issue:4 Topics: Blood Component Transfusion; Combined Modality Therapy; Dinoprostone; Factor VIIa; Female; Fibrinoge	2016
Using antifibrinolytics in the peripartum period - concern for a hypercoagulable effect? Journal of neonatal-perinatal medicine, 2017, Volume: 10, Issue:1 Topics: Adult; Aminocaproic Acid; Antifibrinolytic Agents; Blood Coagulation; Case-Control Studies; Female;	2017
Monitoring low dose recombinant factor VIIa therapy in patients with severe factor XI deficiency undergoing surgery. Thrombosis and haemostasis, 2011, Volume: 106, Issue:3 Topics: Abdomen; Adult; Antifibrinolytic Agents; Cesarean Section; Cholecystectomy; Disease Progression; Dru	2011
Successful treatment of acute promyelocytic leukaemia during pregnancy. Clinical and laboratory haematology, 2002, Volume: 24, Issue:5 Topics: Adolescent; Anticonvulsants; Antineoplastic Combined Chemotherapy Protocols; Cerebral Hemorrhage; Ce	2002
A case of hereditary angio-oedema type III presenting with C1-inhibitor cleavage and a missense mutation in the F12 gene. The British journal of dermatology, 2007, Volume: 156, Issue:5 Topics: Angioedema; Antifibrinolytic Agents; Complement C1 Inhibitor Protein; Female; Humans; Pregnancy; Pre	2007
[Obstetric analgesia for a women with type III hereditary angioneurotic edema]. Revista espanola de anestesiologia y reanimacion, 2007, Volume: 54, Issue:4 Topics: Adult; Analgesia, Epidural; Analgesia, Obstetrical; Anesthetics, Local; Angioedema; Antifibrinolytic	2007

tranexamic acid and Complications, Pregnancy