Postpartum HemorrhageNCT06730919
Risk Factors for Postpartum Hemorrhage
An observational study of Postpartum Hemorrhage and Systemic Autoimmune Diseases, run by RenJi Hospital at 5 sites 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?
- Estimated Blood Loss after cesarean delivery within 24 h
- How many people
- 1,000 participants
- Where
- 5 sitesChina
- Study dates
- 1 Jun 2019to 30 Dec 2024
- Phase
- Observational
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: All women with systemic autoimmune diseases who underwent cesarean delivery in Renji Hospital, School of Medicine, Shanghai Jiaotong University, The First Affiliated Hospital, Sun Yat-sen University, Women's hospital school of medicine zhejiang university，Obstetrics \& Gynecology Hospital of Fudan University，and Shanghai First Maternity and Infant Hospital between June 2019 and June 2024, and who met the inclusion criteria were eligible for the study.
Who may be able to join
- Gestational period was ≥ 28 week;
- Delivered by cesarean delivery;
- With systemic autoimmune diseases (SLE, APS, SSc, SS,RA, UCTD)
Who cannot join
- Intrauterine fetal death
- Hemorrhagic disease, significant prenatal bleeding
- Missing clinical information
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou
Women's hospital school of medicine zhejiang university
Hangzhou
Renji Hospital, Shanghai Jiaotong University, School of Medcine
Shanghai, Shanghai Municipality
Obstetrics & Gynecology Hospital of Fudan University
Shanghai
Shanghai First Maternity and Infant Hospital
Shanghai
About this study
Official title: Risk Factors for Postpartum Hemorrhage After Cesarean Delivery in Women With Systemic Autoimmune Disease: A Multicenter Retrospective Study
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 (SLE) has been reported to be as high as 34%. However, few studies have investigated PPH risk factors in pregnant women with systemic autoimmune disease. Therefore, the purpose of this study is to investigate the incidence and related risk factors of PPH in pregnant women with systemic autoimmune disease, and to provide the latest evidence for further study on prevention of PPH in women at high risk of PPH.
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 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 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%. Antiphospholipid antibodies (APLAs) are often present in SLE and APS patients, which predict serious perinatal complications and are associated with the risk of thrombosis. APLAs 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). Women with positive APLAs during pregnancy usually receive antithrombotic therapy to reduce the incidence of fetal loss, which may increase the risk of PPH, but existing research evidence is insufficient. PPH increases the need for blood transfusion and related complications and is a significant clinical and socio-economic problem. The aim of this study is to investigate the incidence and related risk factors of PPH in pregnant women with systemic autoimmune disease, and to provide the latest evidence for further study on prevention of PPH in women at high risk of PPH.
The investigators will review patients who underwent cesarean delivery in five hospitals between June 2019 and June 2024. The complication of pregnancy, placental function, estimated blood loss 24h postoperatively, blood transfusion 3d postpartum, additional uterotonics, other surgical intervention for PPH and APOs will be recorded. The group of patients included in the analysis for risk factors associated with PPH consisted of those who with systemic autoimmune disease.
- Being tested
- Estimated Blood Loss after cesarean delivery within 24 h
- Keywords
- postpartum hemorrhage, systemic autoimmune disease, cesarean delivery, risk factors
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estimated Blood Loss after cesarean delivery within 24 hDiagnostic test
The total estimated blood loss was calculated by 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
| Study group | Role | What they receive |
|---|---|---|
| PPH group | The EBL after cesarean delivery within 24 h over 1000mL Receives: Diagnostic Test: Estimated Blood Loss after cesarean delivery within 24 h | |
| Non-PPH group | The EBL after cesarean delivery within 24 h not over 1000mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of PPH
PPH is defined as estimated blood loss ≥1000 mL within 24 h after cesarean delivery.
Measured: From skin incision to 1day after surgery
Secondary outcomes (5)
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
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)
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.
Maternal and neonatal mortality 42d after cesarean delivery
All-cause mortality 42d after cesarean delivery.
Measured: From skin incision to 42 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start1 Jun 2019
- Primary completion30 Jun 2024
- Study completion30 Dec 2024
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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
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
- NCT06730919
- Sponsor's protocol ID
- LY2024-274-B
- Status last verified
- Sep 2025
- First submitted
- 8 Dec 2024
- Last updated
- 1 Oct 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 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Postpartum Hemorrhage After Cesarean Delivery in Women With Systemic Autoimmune Disease: A Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT06730919
- Acronym / sponsor ID
- LY2024-274-B
- Keywords
- postpartum hemorrhage, systemic autoimmune disease, cesarean delivery, risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 12 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 (SLE) has been reported to be as high as 34%. However, few studies have investigated PPH risk factors in pregnant women with systemic autoimmune disease. Therefore, the purpose of this study is to investigate the incidence and related risk factors of PPH in pregnant women with systemic autoimmune disease, and to provide the latest evidence for further study on prevention of PPH in women at high risk of PPH.
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 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 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%. Antiphospholipid antibodies (APLAs) are often present in SLE and APS patients, which predict serious perinatal complications and are associated with the risk of thrombosis. APLAs 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). Women with positive APLAs during pregnancy usually receive antithrombotic therapy to reduce the incidence of fetal loss, which may increase the risk of PPH, but existing research evidence is insufficient. PPH increases the need for blood transfusion and related complications and is a significant clinical and socio-economic problem. The aim of this study is to investigate the incidence and related risk factors of PPH in pregnant women with systemic autoimmune disease, and to provide the latest evidence for further study on prevention of PPH in women at high risk of PPH.
The investigators will review patients who underwent cesarean delivery in five hospitals between June 2019 and June 2024. The complication of pregnancy, placental function, estimated blood loss 24h postoperatively, blood transfusion 3d postpartum, additional uterotonics, other surgical intervention for PPH and APOs will be recorded. The group of patients included in the analysis for risk factors associated with PPH consisted of those who with systemic autoimmune disease.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPH group | – | Diagnostic Test: Estimated Blood Loss after cesarean delivery within 24 hThe EBL after cesarean delivery within 24 h over 1000mL |
| Non-PPH group | – | –The EBL after cesarean delivery within 24 h not over 1000mL |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All women with systemic autoimmune diseases who underwent cesarean delivery in Renji Hospital, School of Medicine, Shanghai Jiaotong University, The First Affiliated Hospital, Sun Yat-sen University, Women's hospital school of medicine zhejiang university，Obstetrics \& Gynecology Hospital of Fudan University，and Shanghai First Maternity and Infant Hospital between June 2019 and June 2024, and who met the inclusion criteria were eligible for the study.
Key inclusion criteria (3 listed)
- Gestational period was ≥ 28 week;
- Delivered by cesarean delivery;
- With systemic autoimmune diseases (SLE, APS, SSc, SS,RA, UCTD)
Key exclusion criteria (3 listed)
- Intrauterine fetal death
- Hemorrhagic disease, significant prenatal bleeding
- Missing clinical information
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 |
|---|---|---|
| Estimated Blood Loss after cesarean delivery within 24 hThe total estimated blood loss was calculated by 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 | Diagnostic test | PPH group |
Primary outcome
The incidence of PPH
Time frame: From skin incision to 1day after surgery
PPH is defined as estimated blood loss ≥1000 mL within 24 h after cesarean delivery.
5 secondary outcomes
Estimated blood loss within 1day after surgery
Time frame: From skin incision to 1day after surgery
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.
Maternal and neonatal mortality 42d after cesarean delivery
Time frame: From skin incision to 42 days after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jie Xiao, PHD study director
Renji Hospital, Shanghai Jiaotong University, School of Medcine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Hemorrhage and Systemic Autoimmune Diseases, run by RenJi Hospital at 5 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 3 inclusion and 3 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 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The incidence of PPH (time frame: From skin incision to 1day after surgery). 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 1 Oct 2025.