Clinical trial NCT05811676: Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Pregnant Women With Placenta Previa
Official title: Department of Obstetrics and Gynecology, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, PR China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemorrhage, Postpartum
Placenta Previa
Lead sponsor: Guangzhou Medical University
Sponsor class: OTHER
Collaborators: name: Dongguan Maternal and Child Health Care Hospital
name: Foshan Women's and Children's Hospital
name: BoAi Hospital of Zhongshan
name: Women and Children's Hospital of Chongqing Medical University
name: Tianjin Central Hospital of Gynecology Obstetrics
name: Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University, Jinan
name: Urumqi Maternal and Child Health Care Hospital
name: Zhuhai Women and Children's Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Hunan Provincial Maternal and Child Health Care Hospital
name: Dalian women and children's medical group
name: Nanfang Hospital, Southern Medical University
name: Huadu District People's Hospital of Guangzhou
name: Northwest Women's and Children's Hospital, Xi'an, Shaanxi
name: First Affiliated Hospital, Sun Yat-Sen University
name: Shenzhen Maternity & Child Healthcare Hospital
name: Shenzhen Baoan Women's and Children's Hospital
name: Dongguan People's Hospital
name: First Affiliated Hospital of Xinjiang Medical University
name: Tongji Hospital
name: Peking Union Medical College
name: Second Affiliated Hospital of Guangzhou Medical University
name: Fifth Affiliated Hospital of Guangzhou Medical University
name: Shijiazhuang Obstetrics and Gynecology Hospital
First posted: 2023-04-13
Enrollment: 1732
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of PPH
timeFrame: Day 2
Secondary outcomes:
measure: mean total calculated blood loss
timeFrame: Day 2
measure: mean gravimetrically estimated blood loss
timeFrame: postpartum 24 hours
measure: Number of Participants with additional uterotonic agents treatment
timeFrame: baseline
measure: incidence of postpartum transfusion
timeFrame: baseline
measure: incidence of postpartum iron perfusion
timeFrame: baseline
measure: incidence of hypovolemic shock related to PPH
timeFrame: baseline
measure: incidence of interventional therapy
timeFrame: baseline
measure: incidence of transfer to intensive care unit
timeFrame: baseline
measure: Number of Participants with additional operations performed outside cesarean section
timeFrame: baseline
measure: incidence of maternal death from any cause
timeFrame: week 6
measure: incidence of hospital readmission
timeFrame: baseline
measure: mean peripartum change in hemoglobin
timeFrame: Day 2
measure: mean peripartum change in hematocrit levels
timeFrame: Day 2
measure: incidence of infectious complications
timeFrame: week 6
measure: incidence of maternal thromboembolic events
timeFrame: week 6
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Obstetrics and Gynecology, The Third Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Beijing
country: China
facility: Peking Union Medical College
city: Beijing
country: China
facility: Peking University First Hospital
city: Chongqing
country: China
facility: Women and Children's Hospital of Chongqing Medical University
city: Dalian
country: China
facility: Dalian Women and Children's Medical Group
city: Dongguan
country: China
facility: Dongguan Maternal and Child Health Care Hospital
city: Dongguan
country: China
facility: The Tenth Affiliated Hospital of Southern Medical University; Dongguan People's Hospital
city: Foshan
country: China
facility: Foshan Women and Children Hospital
city: Guangzhou
country: China
facility: Boai Hospital of Zhongshan
city: Guangzhou
country: China
facility: Huadu District People's Hospital of Guangzhou
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University, Guangzhou
city: Guangzhou
country: China
facility: The Fifth Affiliated Hospital of Guangzhou Medical University
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
city: Guangzhou
country: China
facility: The first Affiliated Hospital, Sun Yat-sen University
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
city: Guangzhou
country: China
facility: Zhuhai Women and Children's Hospital
city: Hunan
country: China
facility: Obstetrics Department, the Maternal and Child Health Hospital of Hunan Province
city: Jinan
country: China
facility: Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University
city: Shenzhen
country: China
facility: Shenzhen Baoan Women's and Children's Hospital
city: Shenzhen
country: China
facility: Shenzhen Maternal ＆ Child Healthcare Hospital Affiliated Southern Medical University
city: Shijiazhuang
country: China
facility: Shijiazhuang Obstetrics and Gynecology Hospital
city: Tianjin
country: China
facility: Tianjin Central Hospital of Gynecology Obsterics
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
city: Xi'an
country: China
facility: Northwest Women's and Children's Hospital
city: Xinjiang
country: China
facility: First Affiliated Hospital of Xinjiang Medical University
city: Xinjiang
country: China
facility: Urumqi Maternal and Child Health Care Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
Study officials:
References: