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Hemorrhage, PostpartumPhase 3TRAPPNCT05811676

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

A Phase 3 study testing Tranexamic acid and 0.9% sodium chloride in people with Hemorrhage, Postpartum and Placenta Previa, run by Guangzhou Medical University at 27 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for
Hemorrhage, Postpartum, Placenta Previa
What is being tested?
Tranexamic acid and 0.9% sodium chloride
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,732 participants
Where
27 sitesChina
Study dates
12 Jul 2023to 23 Mar 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

China27 sites

  • 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

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

    Guangzhou, Guangdong, 510150

  • Boai Hospital of Zhongshan

    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

Other trials in China

About this study

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

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.

Being tested
Tranexamic acid, 0.9% sodium chloride
Medical subject headings
Postpartum Hemorrhage, Placenta Previa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tranexamic acidDrug

    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

  • 0.9% sodium chlorideOther

    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

Study groups in NCT05811676
Study groupRoleWhat they receive
study groupExperimentalIntravenous 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
Receives: Drug: Tranexamic acid
control groupPlacebo comparatorIntravenous 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
Receives: Other: 0.9% sodium chloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 .

    Measured: Day 2

Secondary outcomes (15)

  1. 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

    Measured: Day 2

  2. 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

    Measured: postpartum 24 hours

  3. Number of Participants with additional uterotonic agents treatment

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

    Measured: baseline

  4. incidence of postpartum transfusion

    include RBC, plasma, platelet, cryo et al

    Measured: baseline

  5. incidence of postpartum iron perfusion

    Measured: baseline

  6. incidence of hypovolemic shock related to PPH

    Measured: baseline

  7. incidence of interventional therapy

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

    Measured: baseline

  8. incidence of transfer to intensive care unit

    Measured: baseline

  9. Number of Participants with additional operations performed outside cesarean section

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

    Measured: baseline

  10. incidence of maternal death from any cause

    Measured: week 6

  11. incidence of hospital readmission

    Measured: baseline

  12. mean peripartum change in hemoglobin

    the difference between the hemoglobin levels before delivery and at D2

    Measured: Day 2

  13. mean peripartum change in hematocrit levels

    the difference between the hematocrit levels before delivery and at D2

    Measured: Day 2

  14. incidence of infectious complications

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

    Measured: week 6

  15. incidence of maternal thromboembolic events

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

    Measured: week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2023
  2. Study start12 Jul 2023
  3. Primary completion11 Feb 2025
  4. Study completion23 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,732 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05811676
Sponsor's protocol ID
MR-44-23-016012（TRAPP）
Acronym
TRAPP
Status last verified
Aug 2024
First submitted
15 Mar 2023
Last updated
27 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang L, Bi S, Chen L, Du L, He F, Qiao Y, Li Z, Zeng W, Zhao X, Chen X, Li X, Ding G, Zhou W, Sun B, Guo Q, Guo X, Jin F, Wang X, Zhu Q, Sun Q, Jiang S, Wang X, Cai F, Jiang Y, Gao J, Wang Z, Wang Z, Zhang L, Liu JM, Huang L, Yu L, Chen J, Zhang S, Poon LC, Li HT, Chen D; study's collaborator group. Prophylactic tranexamic acid for the prevention of postpartum haemorrhage in women with placenta praevia: multicentre, double blind, randomised, placebo controlled, phase 3 trial. BMJ. 2026 May 13;393:e089636. doi: 10.1136/bmj-2026-089636.

    PubMed 42128454

  • Zhang L, Hu M, Bi S, Poon LC, He F, Li H, Zhang Y, Gu Z, Wang Z, Du L, Chen D; TRAPP Study Group. TRAPP- Protocol for Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Pregnant Women With Placenta Previa. Matern Fetal Med. 2026 Jan;8(1):3-12. doi: 10.1097/FM9.0000000000000297. Epub 2025 Jul 15.

    PubMed 41624591

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tranexamic acid and 0.9% sodium chloride in people with Hemorrhage, Postpartum and Placenta Previa, run by Guangzhou Medical University at 27 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of PPH (time frame: Day 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05811676, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.

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