AzTrials
AzTrials

Postpartum HemorrhagePhase 4NCT06754371

Prophylactic Tranexamic Acid Reduces Postpartum Hemorrhage

A Phase 4 study testing tranexamic acid and normal saline in people with Postpartum Hemorrhage and Systemic Autoimmune Diseases, run by RenJi Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Postpartum hemorrhage (PPH) is the most significant leading cause of pregnancy-related mortality in high-risk cesarean delivery women. Systemic autoimmune diseases are associated with adverse pregnancy outcomes (APOs), including PPH, preeclampsia, thromboembolism, abortion, and intrauterine growth restriction. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
What is being tested?
tranexamic acid and normal saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
276 participants
Where
1 siteChina
Study dates
6 Jan 2025to Jun 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients undergoing cesarean delivery
  • Preoperative diagnosis of pregnancy with systemic autoimmune diseases (systemic lupus erythematosus, antiphospholipid syndrome, systemic sclerosis, Sjogren's syndrome, rheumatoid arthritis, undifferentiated connective tissue disease)
  • Obtain informed consent.

Who cannot join

  • intrauterine fetal death
  • Existing/previous history of thromboembolism
  • Hemorrhagic disease, significant prenatal bleeding
  • Balloon placement of internal iliac artery
  • Allergic to tranexamic acid
  • Severe renal insufficiency (serum creatinine >451μmol/L or blood urea nitrogen >20mmol/L)
  • Epilepsy

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jie Xiao, PHD contact

+13817931390

applexiaomz@163.com

China1 site, 1 recruiting
  • Renji Hospital, Shanghai Jiaotong University, School of Medcine

    Shanghai, Shanghai Municipality

    Jie Xiao, PHD, applexiaomz@163.com

    Recruiting

Other trials in China

About this study

Official title: Safety and Efficacy of Prophylactic Tranexamic Acid in Reducing Postpartum Hemorrhage After Cesarean Delivery in Women with Systemic Autoimmune Disease:A Randomized Controlled Trial

Postpartum hemorrhage (PPH) is the most significant leading cause of pregnancy-related mortality in high-risk cesarean delivery women. Systemic autoimmune diseases are associated with adverse pregnancy outcomes (APOs), including PPH, preeclampsia, thromboembolism, abortion, and intrauterine growth restriction. The incidence of PPH in women with systemic lupus erythematosus has been reported to be as high as 34%. Prevention of PPH is the key to reduce complications in high-risk women. In recent years, a large number of clinical studies have confirmed that the early preventive use of tranexamic acid(TXA) can reduce the amount of blood loss, the need for additional uterine contraction agents, the risk of blood transfusion, and maternal adverse outcomes, and do not increase the risk of thromboembolic events, which can be used to prevent PPH. However, the study population of TXA is mainly low-risk puerpera, and there is still a lack of relevant research on TXA used in pregnant women with systemic autoimmune diseases. The purpose of this study was to evaluate the safety and efficacy of TXA in preventing postpartum hemorrhage after cesarean delivery in women with systemic autoimmune disease, as well as the maternal and neonatal risks associated with systemic autoimmune disease, to provide evidence for clinical practice and further research.

Read the detailed description

The worldwide estimated cumulative prevalence of autoimmune disease is approximately 5%. Studies are often limited by small sample sizes and focused on a specific autoimmune disease such as systemic lupus erythematosus (SLE) and antiphospholipid syndrome (APS), which is characterized by the production of autoantibodies leading to inflammation of multiple organs. Systemic autoimmune diseases are associated with adverse pregnancy outcomes (APOs), including increased cesarean delivery rates, PPH, preeclampsia, thromboembolism, abortion, premature delivery, and intrauterine growth restriction. Preeclampsia is the most commonly reported complication in patients with SLE and is also a high risk factor for PPH. The incidence of PPH in women with SLE has been reported to be as high as 34%. PPH increases the need for blood transfusion and related complications and is a significant clinical and socio-economic problem. Therefore, prevention of PPH is the key to reduce the postpartum complications of high-risk women. At present, the methods commonly used to prevent PPH after cesarean delivery include uterine massage, prophylactic use of uterine contraction agents in the third stage of labor, and early use of TXA. Recent clinical studies of TXA use in high-risk cesarean delivery women have shown that prophylactic use of TXA significantly reduces blood loss, prevents PPH, and reduces ICU admission and length of stay. There was no evidence of an increased risk of maternal-related complications with TXA use. But there is still a lack of relevant research on TXA used in pregnant women with systemic autoimmune diseases. Anti-phospholipid antibodies (aPL) are often present in SLE and APS patients, which predict serious perinatal complications and are associated with the risk of thrombosis. aPL are detected not only in SLE and APS but also in other connective tissue diseases such as systemic sclerosis (SSc), Sjögren's syndrome (SS), rheumatoid arthritis (RA), and undifferentiated connective tissue disease (UCTD). Although TXA has been widely used in patients at high risk for thromboembolism, such as trauma, orthopedics, and cardiac surgery in recent years, the evidence strongly supports that it does not increase the risk of death or thromboembolic complications. More evidence from high quality randomized controlled trials is needed to assess the benefits and risks of its use in women at high risk of PPH after cesarean delivery.

The aim of this study was to evaluate the safety and efficacy of TXA in preventing PPH after cesarean delivery in women with systemic autoimmune disease. Patients undergoing cesarean delivery were randomly assigned to TXA group(intravenous infusion of TXA 1g (20ml) 10min before skin dissection) and placebo group(intravenous infusion of normal saline 20ml 10min before skin dissection).The estimated blood loss 24h postoperatively, blood transfusion 3d postpartum, additional uterotonics, other surgical intervention for PPH and thromboembolic events were recorded.

Being tested
tranexamic acid, normal saline
Keywords
postpartum hemorrhage, systemic autoimmune disease, cesarean delivery, thromboembolism
Medical subject headings
Postpartum Hemorrhage, Thromboembolism

What participants receive

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

  • tranexamic acidDrug

    Also called TXA

    intravenous infusion of tranexamic acid 1g (20ml) 10min before skin dissection

  • normal salineDrug

    intravenous infusion of normal saline 20ml 10min before skin dissection

Study groups in NCT06754371
Study groupRoleWhat they receive
Tranexamic acid groupExperimentalintravenous infusion of tranexamic acid 1g (20ml) 10min before skin dissection
Receives: Drug: tranexamic acid
Placebo groupPlacebo comparatorintravenous infusion of normal saline 20ml 10min before skin dissection
Receives: Drug: normal saline

What is being measured

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

  1. The incidence of postpartum hemorrhage

    Postpartum hemorrhage is defined as blood loss of 1000 mL or more within the first 24 h after cesarean delivery.

    Measured: From skin incision to 1day after surgery

  2. Estimated blood loss within 1day after surgery

    Estimated blood loss is calculated by GROSS EQUATION: Estimated Blood Loss (EBL) = EBV ×((HCT1 - HCT2)/(HCT mean)), EBV = Estimated Blood volume; whereas EBV = Patient's weight (in kilogram) × 70 mL/kg, HCT1=preoperative hematocrit, HCT2 = postoperative hematocrit, and HCT mean = (HCT1 + HCT2)/2;

    Measured: From skin incision to 1day after surgery

Secondary outcomes (7)
  1. The volume of blood transfusion within 3days after surgery and complications

    The volume of blood transfusion within 3days after surgery and complications(such as fever, allergy, hemolysis, renal dysfunction,etc)

    Measured: From skin incision to 3days after surgery

  2. Whether additional uterotonics are needed

    Uterotonics other than intraoperative routine dose intravenous and intrauterine infusion of oxytocin.

    Measured: From the delivery of placenta until 3 days postoperatively

  3. Whether other surgical intervention for PPH are needed

    Patients who need other surgical intervention(such as intrauterine balloon compression hemostasis, uterine artery ligation or embolization and hysterectomy) to control PPH

    Measured: From the delivery of placenta until 3 days postoperatively

  4. Incidence of thromboembolic events

    The occurrence of thromboembolic events within one week of delivery, including deep vein thrombosis, pulmonary embolism, myocardial infarction, and stroke

    Measured: Patients will be followed up to one week after surgery

  5. Maternal complications

    Occurrence of adverse effects (nausea, vomiting, headache, epilepsy, renal impairment,coagulopathy) within 3days after surgery.

    Measured: Patients will be followed up to 3days after surgery

  6. Maternal and neonatal 3 months mortality

    All-cause 3 months mortality

    Measured: Patients and neonates will be followed up to 3 months after surgery

  7. Estimated intraoperative blood loss

    Estimated intraoperative blood loss is calculated using the formula: collected blood volume in the suction canister (ml)-the volume of amniotic fluid (ml)-the volume of flushing (ml) + the volume from the gauze tampon (ml)

    Measured: From skin incision to the end of the surgery

Timeline

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

  1. First posted31 Dec 2024
  2. Study start6 Jan 2025
  3. Primary completionJan 2027 (estimated)
  4. Study completionJun 2027 (estimated)

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
276 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06754371
Sponsor's protocol ID
LY2024-172-B
Status last verified
Mar 2025
First submitted
22 Dec 2024
Last updated
17 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing tranexamic acid and normal saline in people with Postpartum Hemorrhage and Systemic Autoimmune Diseases, run by RenJi Hospital at 1 site 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 17 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 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Jie Xiao, PHD (+13817931390, applexiaomz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of postpartum hemorrhage (time frame: From skin incision to 1day after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 17 Mar 2025.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in