Risk Factors for Postpartum Hemorrhage

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage; Systemic Autoimmune Diseases
• Intervention / Treatment: Diagnostic test: Estimated Blood Loss after cesarean delivery within 24 h

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 Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• China
  • Guangzhou, China
    • The First Affiliated Hospital, Sun Yat-sen University
  • Hangzhou, China
    • Women's Hospital School of Medicine Zhejiang University
  • Shanghai, China
    • Shanghai First Maternity and Infant Hospital
  • Shanghai, China
    • Obstetrics & Gynecology Hospital of Fudan University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Renji Hospital, Shanghai Jiaotong University, School of Medcine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

1. Gestational period was ≥ 28 week;
2. Delivered by cesarean delivery;
3. With systemic autoimmune diseases (SLE, APS, SSc, SS,RA, UCTD)

Exclusion Criteria:

1. Intrauterine fetal death
2. Hemorrhagic disease, significant prenatal bleeding
3. Missing clinical information

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PPH group; The EBL after cesarean delivery within 24 h over 1000mL	Diagnostic test: Estimated Blood Loss after cesarean delivery within 24 h; 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
Non-PPH group; The EBL after cesarean delivery within 24 h not over 1000mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of PPH	PPH is defined as estimated blood loss ≥1000 mL within 24 h after cesarean delivery.	From skin incision to 1day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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;	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)	From skin incision to 3days after surgery
Whether additional uterotonics are needed	Uterotonics other than intraoperative routine dose intravenous and intrauterine infusion of oxytocin.	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.	From the delivery of placenta until 3 days postoperatively.
Maternal and neonatal mortality 42d after cesarean delivery	All-cause mortality 42d after cesarean delivery.	From skin incision to 42 days after surgery.

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Study Director: Jie Xiao, PHD, Renji Hospital, Shanghai Jiaotong University, School of Medcine

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: December 8, 2024
• First Submitted That Met QC Criteria: December 8, 2024
• First Posted (Actual): December 12, 2024

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 25, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: risk factors; postpartum hemorrhage; cesarean delivery; systemic autoimmune disease
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Hemorrhage; Puerperal Disorders; Uterine Hemorrhage; Pathological Conditions, Signs and Symptoms; Postpartum Hemorrhage
• Other Study ID Numbers: LY2024-274-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No