Risk Factors for Postpartum Hemorrhage

NCT06730919 | Completed DMC

• 1 other identifier: LY2024-274-B
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 5

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.

Conditions

Postpartum Hemorrhage; Systemic Autoimmune Diseases

Keywords

postpartum hemorrhage; systemic autoimmune disease; cesarean delivery; risk factors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Estimated blood loss within 1day after surgery

  From skin incision to 1day after surgery

• The volume of blood transfusion within 3days after surgery and complications

  From skin incision to 3days after surgery

• Whether additional uterotonics are needed

  From the delivery of placenta until 3 days postoperatively.

• Whether other surgical intervention for PPH are needed

  From the delivery of placenta until 3 days postoperatively.

• Maternal and neonatal mortality 42d after cesarean delivery

  From skin incision to 42 days after surgery.

Study Arms (2)

PPH group

The EBL after cesarean delivery within 24 h over 1000mL

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

Interventions

Estimated Blood Loss after cesarean delivery within 24 h DIAGNOSTIC_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

PPH group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• Intrauterine fetal death
• Hemorrhagic disease, significant prenatal bleeding
• Missing clinical information

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (5)

Renji Hospital, Shanghai Jiaotong University, School of Medcine

Shanghai, Shanghai Municipality, China

Location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, China

Location

Women's hospital school of medicine zhejiang university

Hangzhou, China

Location

Obstetrics & Gynecology Hospital of Fudan University

Shanghai, China

Location

Shanghai First Maternity and Infant Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jie Xiao, PHD

  Renji Hospital, Shanghai Jiaotong University, School of Medcine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: December 12, 2024
• Study Start: June 1, 2019
• Primary Completion: June 30, 2024
• Study Completion: December 30, 2024
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)