Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Pregnant Women With Placenta Previa

Placenta Previa Clinical Trial

— TRAPP  

Official title:

Department of Obstetrics and Gynecology, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, PR China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05811676
• Other study ID #: MR-44-23-016012(TRAPP)
• Status: Recruiting
• Phase: Phase 3
• Start date: July 12, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: August 2023
• Source: Guangzhou Medical University
• Contact: Lizi Zhang
• Phone: +8613265352553
• Email: 2022390064[@]gzhmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Many RCT(randomized controlled trial) studies reported that tranexamic acid reduced blood loss in women who had elective cesareans. However, most of these elective cesareans are without high-risk factors of postpartum hemorrhage, such as placenta previa. The prophylactic use of tranexamic acid in the placenta previa is not clear. studies had poor quality and lacked adequate power to assess severe adverse events.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1680
• Est. completion date: September 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Age of 18 years or older
• Diagnosed with Placenta previa before cesarean delivery by ultrasound(Placenta previa defined by a placental edge below 20mm from internal cervical os diagnosed at the most recent transvaginal ultrasound examination before delivery)
• Gestational age = 34 weeks
• Available venous hematocrit value in the week before the cesarean
• Prenatal hemoglobin level in the week before the cesarean > 90 g/l
• Undergoing cesarean delivery
• Signed informed consent

Exclusion Criteria:

• Known hypersensitivity to tranexamic acid or concentrated hydrochloric acid
• History of venous (deep vein thrombosis and/or pulmonary embolism) or arterial thrombosis (angina pectoris, myocardial infarction, or stroke)
• History of epilepsy or seizure
• Any known active cancer, active cardiovascular, renal, or liver disorders
• Autoimmune diseases such as lupus, rheumatoid arthritis, Sjogren's disease, and inflammatory bowel disease
• Sickle cell disease
• Severe hemorrhagic disease
• Administration of low-molecular-weight heparin or antiplatelet agents within one week prior to delivery
• Severe coagulation disorders with prothrombin time or activated partial thromboplastin time exceeding the upper limit of normal, or platelet count less than 80×109/L
• placenta abruption
• In-utero fetal death
• Eclampsia or HELLP syndrome
• Acquired color vision deficiency or subarachnoid hemorrhage
• Severe bleeding with estimated blood loss exceeding 500 ml, within 12 hours before cesarean delivery
• Known congenital or acquired thrombophilias, including antiphospholipid antibody syndrome
• Participation in another intervention study where the primary outcome includes postpartum bleeding or thromboembolism or the study intervention potentially affects postpartum bleeding or thromboembolism

Related Conditions & MeSH terms

• Hemorrhage
• Hemorrhage, Postpartum
• Placenta Previa
• Postpartum Hemorrhage

Intervention

Drug:
• Tranexamic acid
Intravenous administration of 10 mL (1 g of tranexamic acid), diluted in 40 ml of normal saline, over 10 minutes after umbilical-cord clamping, the routine prophylactic uterotonic administration

Other:
• 0.9% sodium chloride
Intravenous administration of 10 mL placebo(0.9% sodium chloride), diluted in 40 ml of normal saline, over 10 minutes after umbilical-cord clamping, the routine prophylactic uterotonic administration

Locations

Country	Name	City	State
China	Peking Union Medical College	Beijing
China	Peking University First Hospital	Beijing
China	Women and Children's Hospital of Chongqing Medical University	Chongqing
China	Dalian Women and Children's Medical Group	Dalian
China	Dongguan Maternal and Child Health Care Hospital	Dongguan
China	The Tenth Affiliated Hospital of Southern Medical University; Dongguan People's Hospital	Dongguan
China	Foshan Women and Children Hospital	Foshan
China	Boai Hospital of Zhongshan	Guangzhou
China	Department of Obstetrics and Gynecology, The Third Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Huadu District People's Hospital of Guangzhou	Guangzhou
China	Nanfang Hospital, Southern Medical University, Guangzhou	Guangzhou
China	The Fifth Affiliated Hospital of Guangzhou Medical University	Guangzhou
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou
China	The first Affiliated Hospital, Sun Yat-sen University	Guangzhou
China	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou
China	Zhuhai Women and Children's Hospital	Guangzhou
China	Obstetrics Department, the Maternal and Child Health Hospital of Hunan Province	Hunan
China	Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University	Jinan
China	Shenzhen Baoan Women's and Children's Hospital	Shenzhen
China	Shenzhen Maternal & Child Healthcare Hospital Affiliated Southern Medical University	Shenzhen
China	Shijiazhuang Obstetrics and Gynecology Hospital	Shijiazhuang
China	Tianjin Central Hospital of Gynecology Obsterics	Tianjin
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan
China	Northwest Women's and Children's Hospital	Xi'an
China	First Affiliated Hospital of Xinjiang Medical University	Xinjiang
China	Urumqi Maternal and Child Health Care Hospital	Xinjiang
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou

Sponsors (27)

Lead Sponsor

Collaborator

Guangzhou Medical University

BoAi Hospital of Zhongshan, Dalian women and children's medical group, Dongguan Maternal and Child Health Care Hospital, Dongguan People's Hospital, Fifth Affiliated Hospital of Guangzhou Medical University, First Affiliated Hospital of Xinjiang Medical University, First Affiliated Hospital, Sun Yat-Sen University, Foshan Women and Children Hospital, Huadu District People's Hospital of Guangzhou, Hunan Provincial Maternal and Child Health Care Hospital, Nanfang Hospital, Southern Medical University, Northwest Women's and Children's Hospital, Xi'an, Shaanxi, Peking Union Medical College, Peking University First Hospital, Second Affiliated Hospital of Guangzhou Medical University, Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University, Jinan, Shenzhen Baoan Women's and Children's Hospital, Shenzhen Maternity & Child Healthcare Hospital, Shijiazhuang Obstetrics and Gynecology Hospital, The First Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Zhengzhou University, Tianjin Central Hospital of Gynecology Obstetrics, Tongji Hospital, Urumqi Maternal and Child Health Care Hospital, Women and Children's Hospital of Chongqing Medical University, Zhuhai Women and Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of PPH	defined by a calculated estimated blood loss > 1000 mL [Calculated estimated blood loss = estimated blood volume × (preoperative hematocrit - postoperative hematocrit)/preoperative hematocrit (where estimated blood volume (mL) = weight (Kg) × 85)] or red blood cell (RBC) transfusion before day 2 postpartum .	Day 2
Secondary	mean total calculated blood loss	Calculated estimated blood loss = estimated blood volume × (preoperative hematocrit - postoperative hematocrit)/preoperative hematocrit (where estimated blood volume (mL) = weight (Kg) × 85)] or red blood cell (RBC) transfusion before day 2 postpartum	Day 2
Secondary	mean gravimetrically estimated blood loss	estimated blood loss = (weight of materials used + materials not used - weight of all materials before surgery)/ 1.05 + volume included in the suction container	postpartum 24 hours
Secondary	Number of Participants with additional uterotonic agents treatment	additional uterotonic agents include oxytocin, carbetocin, carboprost, misoprostol, ergonovine et al	baseline
Secondary	incidence of postpartum transfusion	include RBC, plasma, platelet, cryo et al	baseline
Secondary	incidence of postpartum iron perfusion		baseline
Secondary	incidence of hypovolemic shock related to PPH		baseline
Secondary	incidence of interventional therapy	include arterial embolization, abdominal aortic balloon, internal iliac artery/common iliac artery balloon et al	baseline
Secondary	incidence of transfer to intensive care unit		baseline
Secondary	Number of Participants with additional operations performed outside cesarean section	Additional operations include B-Lnych, uterine artery suture, partial hysterectomy, hysterectomy et al	baseline
Secondary	incidence of maternal death from any cause		week 6
Secondary	incidence of hospital readmission		baseline
Secondary	mean peripartum change in hemoglobin	the difference between the hemoglobin levels before delivery and at D2	Day 2
Secondary	mean peripartum change in hematocrit levels	the difference between the hematocrit levels before delivery and at D2	Day 2
Secondary	incidence of infectious complications	include endometritis, surgical-site infection, or pelvic abscess within 6 weeks post partum	week 6
Secondary	incidence of maternal thromboembolic events	including venous, arterial, or ischemic stroke or myocardial infarction within 6 weeks post partum	week 6