Department of Obstetrics and Gynecology, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, PR China
Status: Completed
Location: See all (27) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:
• 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
Locations
Other Locations
China
Peking Union Medical College
Beijing
Peking University First Hospital
Beijing
Women and Children's Hospital of Chongqing Medical University
Chongqing
Dalian Women and Children's Medical Group
Dalian
Dongguan Maternal and Child Health Care Hospital
Dongguan
The Tenth Affiliated Hospital of Southern Medical University; Dongguan People's Hospital
Dongguan
Foshan Women and Children Hospital
Foshan
Boai Hospital of Zhongshan
Guangzhou
Department of Obstetrics and Gynecology, The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou
Huadu District People's Hospital of Guangzhou
Guangzhou
Nanfang Hospital, Southern Medical University, Guangzhou
Guangzhou
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou
The first Affiliated Hospital, Sun Yat-sen University
Guangzhou
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou
Zhuhai Women and Children's Hospital
Guangzhou
Obstetrics Department, the Maternal and Child Health Hospital of Hunan Province
Hunan
Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University
Jinan
Shenzhen Baoan Women's and Children's Hospital
Shenzhen
Shenzhen Maternal ＆ Child Healthcare Hospital Affiliated Southern Medical University
Shenzhen
Shijiazhuang Obstetrics and Gynecology Hospital
Shijiazhuang
Tianjin Central Hospital of Gynecology Obsterics
Tianjin
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Northwest Women's and Children's Hospital
Xi'an
First Affiliated Hospital of Xinjiang Medical University
Xinjiang
Urumqi Maternal and Child Health Care Hospital
Xinjiang
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Time Frame
Start Date: 2023-07-12
Completion Date: 2025-03-23
Participants
Target number of participants: 1732
Treatments
Experimental: study group
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
Placebo_comparator: control group
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
Related Therapeutic Areas
Sponsors
Leads: Guangzhou Medical University
Collaborators: Zhuhai Women and Children's Hospital, Fifth Affiliated Hospital of Guangzhou Medical University, Huadu District People's Hospital of Guangzhou, Women and Children's Hospital of Chongqing Medical University, Peking Union Medical College, Urumqi Maternal and Child Health Care Hospital, Shenzhen Maternity & Child Healthcare Hospital, First Affiliated Hospital, Sun Yat-Sen University, Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University, Jinan, Second Affiliated Hospital of Guangzhou Medical University, Northwest Women's and Children's Hospital, Xi'an, Shaanxi, Tianjin Central Hospital of Gynecology Obstetrics, Dongguan Maternal and Child Health Care Hospital, Dalian women and children's medical group, The First Affiliated Hospital of Zhengzhou University, Nanfang Hospital, Southern Medical University, Hunan Provincial Maternal and Child Health Care Hospital, First Affiliated Hospital of Xinjiang Medical University, BoAi Hospital of Zhongshan, Foshan Women's and Children's Hospital, Tongji Hospital, Shijiazhuang Obstetrics and Gynecology Hospital, Dongguan People's Hospital, Shenzhen Baoan Women's and Children's Hospital