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

Primary Purpose

Hemorrhage, Postpartum, Placenta Previa

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Tranexamic acid

0.9% sodium chloride

About this trial

This is an interventional prevention trial for Hemorrhage, Postpartum

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

study group

control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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 .

Secondary Outcome Measures

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

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

Number of Participants with additional uterotonic agents treatment

additional uterotonic agents include oxytocin, carbetocin, carboprost, misoprostol, ergonovine et al

incidence of postpartum transfusion

include RBC, plasma, platelet, cryo et al

incidence of postpartum iron perfusion

incidence of hypovolemic shock related to PPH

incidence of interventional therapy

include arterial embolization, abdominal aortic balloon, internal iliac artery/common iliac artery balloon et al

incidence of transfer to intensive care unit

Number of Participants with additional operations performed outside cesarean section

Additional operations include B-Lnych, uterine artery suture, partial hysterectomy, hysterectomy et al

incidence of maternal death from any cause

incidence of hospital readmission

mean peripartum change in hemoglobin

the difference between the hemoglobin levels before delivery and at D2

mean peripartum change in hematocrit levels

the difference between the hematocrit levels before delivery and at D2

incidence of infectious complications

include endometritis, surgical-site infection, or pelvic abscess within 6 weeks post partum

incidence of maternal thromboembolic events

including venous, arterial, or ischemic stroke or myocardial infarction within 6 weeks post partum

Full Information

NCT ID

NCT05811676

First Posted

March 15, 2023

Last Updated

August 11, 2023

Sponsor

Guangzhou Medical University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05811676

Brief Title

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

Acronym

TRAPP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 12, 2023 (Actual)

Primary Completion Date

July 1, 2024 (Anticipated)

Study Completion Date

September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guangzhou Medical University

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemorrhage, Postpartum, Placenta Previa

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1680 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

study group

Arm Type

Experimental

Arm Description

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

Arm Title

control group

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Tranexamic acid

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

0.9% sodium chloride

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of PPH

Description

Time Frame

Day 2

Secondary Outcome Measure Information:

Title

mean total calculated blood loss

Description

Time Frame

Day 2

Title

mean gravimetrically estimated blood loss

Description

estimated blood loss = (weight of materials used + materials not used - weight of all materials before surgery)/ 1.05 + volume included in the suction container

Time Frame

postpartum 24 hours

Title

Number of Participants with additional uterotonic agents treatment

Description

additional uterotonic agents include oxytocin, carbetocin, carboprost, misoprostol, ergonovine et al

Time Frame

baseline

Title

incidence of postpartum transfusion

Description

include RBC, plasma, platelet, cryo et al

Time Frame

baseline

Title

incidence of postpartum iron perfusion

Time Frame

baseline

Title

incidence of hypovolemic shock related to PPH

Time Frame

baseline

Title

incidence of interventional therapy

Description

include arterial embolization, abdominal aortic balloon, internal iliac artery/common iliac artery balloon et al

Time Frame

baseline

Title

incidence of transfer to intensive care unit

Time Frame

baseline

Title

Number of Participants with additional operations performed outside cesarean section

Description

Additional operations include B-Lnych, uterine artery suture, partial hysterectomy, hysterectomy et al

Time Frame

baseline

Title

incidence of maternal death from any cause

Time Frame

week 6

Title

incidence of hospital readmission

Time Frame

baseline

Title

mean peripartum change in hemoglobin

Description

the difference between the hemoglobin levels before delivery and at D2

Time Frame

Day 2

Title

mean peripartum change in hematocrit levels

Description

the difference between the hematocrit levels before delivery and at D2

Time Frame

Day 2

Title

incidence of infectious complications

Description

include endometritis, surgical-site infection, or pelvic abscess within 6 weeks post partum

Time Frame

week 6

Title

incidence of maternal thromboembolic events

Description

including venous, arterial, or ischemic stroke or myocardial infarction within 6 weeks post partum

Time Frame

week 6

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lizi Zhang

Phone

+8613265352553

2022390064@gzhmu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Lili Du

Phone

+8613826221586

lilidugysy@gzhmu.edu.cn

Facility Information:

Facility Name

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

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510150

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lizi Zhang

Phone

+8613265352553

2022390064@gzhmu.edu.cn

First Name & Middle Initial & Last Name & Degree

Dunjin Chen

First Name & Middle Initial & Last Name & Degree

Lili Du

First Name & Middle Initial & Last Name & Degree

Fang He

First Name & Middle Initial & Last Name & Degree

Yuliang Zhang

First Name & Middle Initial & Last Name & Degree

Miao Hu

First Name & Middle Initial & Last Name & Degree

Lin Yu

First Name & Middle Initial & Last Name & Degree

Zhongjia Gu

First Name & Middle Initial & Last Name & Degree

Zhenping Yan

First Name & Middle Initial & Last Name & Degree

Shilei Bi

Facility Name

Peking Union Medical College

City

Beijing

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Huiying Hu

First Name & Middle Initial & Last Name & Degree

Jinsong Gao

Facility Name

Peking University First Hospital

City

Beijing

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jingmei Ma

First Name & Middle Initial & Last Name & Degree

Jingmei Ma

First Name & Middle Initial & Last Name & Degree

Zhirong Guo

First Name & Middle Initial & Last Name & Degree

Xin Wen

Facility Name

Women and Children's Hospital of Chongqing Medical University

City

Chongqing

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Haoran Li

Phone

18883178896

First Name & Middle Initial & Last Name & Degree

Wei Zhou

First Name & Middle Initial & Last Name & Degree

Qimei Zhong

First Name & Middle Initial & Last Name & Degree

Zhaoming Liu

First Name & Middle Initial & Last Name & Degree

Hongbo Qi

Facility Name

Dalian Women and Children's Medical Group

City

Dalian

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xin Jin

First Name & Middle Initial & Last Name & Degree

Qiang Sun

First Name & Middle Initial & Last Name & Degree

Li Kang

Facility Name

Dongguan Maternal and Child Health Care Hospital

City

Dongguan

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qingwo Lu

Phone

13713389486

First Name & Middle Initial & Last Name & Degree

Jiefei Guo

First Name & Middle Initial & Last Name & Degree

Xinghe Wang

Facility Name

The Tenth Affiliated Hospital of Southern Medical University; Dongguan People's Hospital

City

Dongguan

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhongjun Li

First Name & Middle Initial & Last Name & Degree

Suran Huang

First Name & Middle Initial & Last Name & Degree

Yuting Xiang

First Name & Middle Initial & Last Name & Degree

Yijing Ou

Facility Name

Foshan Women and Children Hospital

City

Foshan

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Meizhuang Chen

Phone

18022235530

First Name & Middle Initial & Last Name & Degree

Xiaoling Guo

First Name & Middle Initial & Last Name & Degree

Zhengping Liu

Facility Name

Boai Hospital of Zhongshan

City

Guangzhou

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yuanjuan Ye

First Name & Middle Initial & Last Name & Degree

Yujie Gan

First Name & Middle Initial & Last Name & Degree

Fenge Cai

Facility Name

Huadu District People's Hospital of Guangzhou

City

Guangzhou

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaohuan Li

First Name & Middle Initial & Last Name & Degree

Shaoqing Jiang

First Name & Middle Initial & Last Name & Degree

Yan Li

First Name & Middle Initial & Last Name & Degree

Weifen Zhong

First Name & Middle Initial & Last Name & Degree

Yiwei Qin

Facility Name

Nanfang Hospital, Southern Medical University, Guangzhou

City

Guangzhou

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xinyang Shen

Phone

18816832492

xinyangshen1990@163.com

First Name & Middle Initial & Last Name & Degree

Zhijian Wang

First Name & Middle Initial & Last Name & Degree

Jin Jin

Facility Name

The first Affiliated Hospital, Sun Yat-sen University

City

Guangzhou

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Songqing Deng

First Name & Middle Initial & Last Name & Degree

Zilian Wang

Facility Name

Zhuhai Women and Children's Hospital

City

Guangzhou

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yunmei Wu

First Name & Middle Initial & Last Name & Degree

Fengmei Jin

First Name & Middle Initial & Last Name & Degree

Hongxia Zhang

First Name & Middle Initial & Last Name & Degree

Zhaosheng Li

Facility Name

Obstetrics Department, the Maternal and Child Health Hospital of Hunan Province

City

Hunan

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ping Li

First Name & Middle Initial & Last Name & Degree

Yurong Jiang

Facility Name

Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University

City

Jinan

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cancan Zhang

Phone

18363065101

sdzhangcancan@163.com

First Name & Middle Initial & Last Name & Degree

Xietong Wang

First Name & Middle Initial & Last Name & Degree

Yan Lian

Facility Name

Shenzhen Baoan Women's and Children's Hospital

City

Shenzhen

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Min Lei

First Name & Middle Initial & Last Name & Degree

Yuanfang Zhu

First Name & Middle Initial & Last Name & Degree

Bo Sun

Facility Name

Shenzhen Maternal ＆ Child Healthcare Hospital Affiliated Southern Medical University

City

Shenzhen

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Danni Yang

Phone

13713632426

yangdanni@szmch.net.cn

First Name & Middle Initial & Last Name & Degree

Xiaotian Li

First Name & Middle Initial & Last Name & Degree

Xinzhi Tu

First Name & Middle Initial & Last Name & Degree

Duo Xu

First Name & Middle Initial & Last Name & Degree

Yue Li

First Name & Middle Initial & Last Name & Degree

Danni Yang

Facility Name

Tianjin Central Hospital of Gynecology Obsterics

City

Tianjin

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hao Geng

First Name & Middle Initial & Last Name & Degree

Xu Chen

First Name & Middle Initial & Last Name & Degree

Hongyan Cui

Facility Name

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

City

Wuhan

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yanyan Liu

First Name & Middle Initial & Last Name & Degree

Wanjiang Zeng

First Name & Middle Initial & Last Name & Degree

Haiyi Liu

Facility Name

Northwest Women's and Children's Hospital

City

Xi'an

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yuan Qiao

First Name & Middle Initial & Last Name & Degree

Yinli Cao

First Name & Middle Initial & Last Name & Degree

Tongqiang He

Facility Name

First Affiliated Hospital of Xinjiang Medical University

City

Xinjiang

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ru Yang

Phone

13179833235

First Name & Middle Initial & Last Name & Degree

Qiying Zhu

First Name & Middle Initial & Last Name & Degree

Jianli Wu

Facility Name

Urumqi Maternal and Child Health Care Hospital

City

Xinjiang

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Luhan Zhang

Phone

18097621897

1282950497@qq.com

First Name & Middle Initial & Last Name & Degree

Guifeng Ding

First Name & Middle Initial & Last Name & Degree

Li Yan

Facility Name

The First Affiliated Hospital of Zhengzhou University

City

Zhengzhou

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xinyan Wang

Phone

13623858397

First Name & Middle Initial & Last Name & Degree

Xianlan Zhao

First Name & Middle Initial & Last Name & Degree

Huan Yan

12. IPD Sharing Statement

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

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