The Effectiveness of a Care Bundle to Prevent Postpartum Hemorrhage After Cesarean Delivery

Not Applicable

Not yet recruiting

• Conditions: Cesarean Delivery

• Registration Number: NCT06684080
• Lead Sponsor: Dunjin Chen

Brief Summary

Delays in the detection or inconsistent use of effective interventions of postpartum hemorrhage can result in complications or death. We designed a cluster-randomized trial to assess a multi-component strategy for the detection and treatment of postpartum hemorrhage after cesarean delivery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-29
• Study First Submitted QC: 2024-11-11
• Study First Posted: 2024-11-12
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-31
• Study Start: 2025-01-01
• Last Update Posted: 2025-03-25
• Primary Completion: 2026-12-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 52000

Inclusion Criteria

• Hospital level

  1. Public hospitals
  2. There are more than 100 cesarean deliveries per year

• Patient level

  1. Cesarean delivery
  2. Sign informed consent

Exclusion Criteria

• Hospital level

  1. Data verification information cannot be provided

• Pregnant woman level 1. No blood routine results within 2 weeks before surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of PPH	Day 2	defined by a calculated estimated blood loss \> 1000 mL \[Calculated estimated blood loss = estimated blood volume × (preoperative hematocrit - postoperative hematocrit)/preoperative hematocrit (where estimated blood volume (mL) = weight (Kg) × 85)\] or red blood cell (RBC) transfusion before day 2 postpartum .

Secondary Outcome Measures

Name	Time	Method
mean total calculated blood loss	Day 2	Calculated estimated blood loss = estimated blood volume × (preoperative hematocrit - postoperative hematocrit)/preoperative hematocrit (where estimated blood volume (mL) = weight (Kg) × 85)\]
Estimated blood loss	postpartum 24 hours	Estimated intraoperative and postoperative blood loss at 24 hours
Incidence of postpartum transfusion	baseline	infusion of RBC, plasma, platelet, or cryo et al
Incidence of additional operations performed outside cesarean section	baseline	Additional operations include B-Lnych, uterine artery suture, partial hysterectomy, hysterectomy et al
Incidence of transfer to intensive care unit	baseline	transfer to intensive care unit
Incidence of maternal death from any cause	Up to 42 days	maternal death from any cause
The adherence to the treatment bundle	intraoperation and postpartum 24 hours	defined adherence to at least four core bundle elements: risk evaluation for PPH and reserve plan, maintaining uterus tone (administration of oxytocin and second-line medications to promote uterine contraction), intravenous infusion, administered tranexamic acid