Risk Factors for Postpartum Hemorrhage

Completed

• Conditions: Postpartum Hemorrhage; Systemic Autoimmune Diseases

• Registration Number: NCT06730919
• Lead Sponsor: RenJi Hospital

Brief 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. 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 Renji hospital between February 2023 and August 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 Timeline

• Study Start: 2023-01-01
• Primary Completion: 2024-06-30
• Study First Submitted: 2024-12-08
• Study First Submitted QC: 2024-12-08
• Study First Posted: 2024-12-12
• Study Completion: 2025-03-13
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-19
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1757

Inclusion Criteria

1. Patients underwent cesarean delivery
2. Exempt informed consent

Exclusion Criteria

1. Intrauterine fetal death
2. Hemorrhagic disease, significant prenatal bleeding

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Whether other surgical intervention for PPH are needed	From the delivery of placenta until 3 days postoperatively.	Patients who need other surgical intervention(such as intrauterine balloon compression hemostasis, uterine artery ligation or embolization and hysterectomy) to control PPH.
Maternal and neonatal mortality 42d after cesarean delivery	From skin incision to 42 days after surgery.	All-cause mortality 42d after cesarean delivery.
Estimated blood loss within 1day after surgery	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;
The volume of blood transfusion within 3days after surgery and complications	From skin incision to 3days after surgery	The volume of blood transfusion within 3days after surgery and complications(such as fever, allergy, hemolysis, renal dysfunction)
Whether additional uterotonics are needed	From the delivery of placenta until 3 days postoperatively.	Uterotonics other than intraoperative routine dose intravenous and intrauterine infusion of oxytocin.

Trial Locations

Locations (1)

Renji Hospital, Shanghai Jiaotong University, School of Medcine; 🇨🇳 Shanghai, Shanghai, China