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.
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
- Conditions the study is for
- Postpartum Hemorrhage, Systemic Autoimmune Diseases
- 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.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, Shanghai Jiaotong University, School of Medcine
Shanghai, Shanghai Municipality
Jie Xiao, PHD, applexiaomz@163.com
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 group | Role | What they receive |
|---|---|---|
| Tranexamic acid group | Experimental | intravenous infusion of tranexamic acid 1g (20ml) 10min before skin dissection Receives: Drug: tranexamic acid |
| Placebo group | Placebo comparator | intravenous 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.
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
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)
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
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
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
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
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
Maternal and neonatal 3 months mortality
All-cause 3 months mortality
Measured: Patients and neonates will be followed up to 3 months after surgery
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.
- First posted31 Dec 2024
- Study start6 Jan 2025
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jie Xiao, PHD, Study director, Renji Hospital, Shanghai Jiaotong University, School of Medcine
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06754371
- Acronym / sponsor ID
- LY2024-172-B
- Keywords
- postpartum hemorrhage, systemic autoimmune disease, cesarean delivery, thromboembolism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid group | Experimental | Drug: tranexamic acidintravenous infusion of tranexamic acid 1g (20ml) 10min before skin dissection |
| Placebo group | Placebo comparator | Drug: normal salineintravenous infusion of normal saline 20ml 10min before skin dissection |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- intrauterine fetal death
- Existing/previous history of thromboembolism
- Hemorrhagic disease, significant prenatal bleeding
- Balloon placement of internal iliac artery
- Allergic to tranexamic acid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tranexamic acidAlso: TXAintravenous infusion of tranexamic acid 1g (20ml) 10min before skin dissection | Drug | Tranexamic acid group |
| normal salineintravenous infusion of normal saline 20ml 10min before skin dissection | Drug | Placebo group |
Primary outcome
The incidence of postpartum hemorrhage
Time frame: From skin incision to 1day after surgery
Postpartum hemorrhage is defined as blood loss of 1000 mL or more within the first 24 h after cesarean delivery.
Estimated blood loss within 1day after surgery
Time frame: From skin incision to 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;
7 secondary outcomes
The volume of blood transfusion within 3days after surgery and complications
Time frame: From skin incision to 3days after surgery
Whether additional uterotonics are needed
Time frame: From the delivery of placenta until 3 days postoperatively
Whether other surgical intervention for PPH are needed
Time frame: From the delivery of placenta until 3 days postoperatively
Incidence of thromboembolic events
Time frame: Patients will be followed up to one week after surgery
Maternal complications
Time frame: Patients will be followed up to 3days after surgery
Maternal and neonatal 3 months mortality
Time frame: Patients and neonates will be followed up to 3 months after surgery
Estimated intraoperative blood loss
Time frame: From skin incision to the end of the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Postpartum Hemorrhage
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Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
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Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
RecruitingPhase 2
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
RecruitingObservational study
Hemoglobin Testing in Pregnant Patients
Post Partum Hemorrhage, Anemia of Pregnancy
RecruitingPhase 4
Carbetocin Monotherapy Versus Carbetocin Plus Oxytocin Infusion in Elective Cesarean Delivery: A Non-Inferiority Trial
Postpartum Hemorrhage, Uterine Atony
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jie Xiao, PHD study director
Renji Hospital, Shanghai Jiaotong University, School of Medcine
1 site in 1 country: see every site and its status.
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.