Reducing Postpartum Hemorrhage After Vaginal Delivery
- Conditions
- Vaginal DeliveryPostpartum Hemorrhage
- Interventions
- Other: Integrated Improvement strategies
- Registration Number
- NCT05501106
- Lead Sponsor
- Peking University Third Hospital
- Brief Summary
Postpartum hemorrhage is the primary cause threatening the life safety of pregnant women in the world and China, and also the main cause of hysterectomy for women giving birth. The management of postpartum hemorrhage necessitates a coordinated multidisciplinary approach but limited available data on this issue. This program aims to evaluate the effectiveness and acceptability of the integrated strategies, on postpartum hemorrhage after vaginal delivery and relevant clinical practice, in response to the increasing incidence of postpartum hemorrhage and its long-standing threaten to the life safety of pregnant women.
A matched-pair, cluster-randomized controlled trial will be conducted among 50 maternity hospitals with at least 500 vaginal deliveries annually from five provinces in China. Recruited hospitals will be randomly assigned in a 1:1 ratio to either the experimental or comparison arms. All hospitals will receive general interventions, including: recommendation for implementing quality improvement programs to reduce vaginal delivery complications; trainings on obstetric quality management and clinical skills (3 times a year); and monitoring postpartum hemorrhage rate every month. The hospitals in the experimental group will additionally implement integrated improvement strategies which include postpartum hemorrhage risk screening, hierarchical management and preparedness, rescue recording, and case review. The primary outcome is the rate of postpartum hemorrhage, and the secondary outcomes include rate of consequent adverse outcomes, adherence to all known best practices, and staff acceptability to the interventions. These outcomes will be measured and compared between the experimental and control groups. Both intention-to-treat and per-protocol analyses will be performed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 50
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Arm Integrated Improvement strategies The hospitals in the experimental group will receive general interventions and additionally implement integrated improvement strategies which include postpartum hemorrhage risk screening, hierarchical management and preparedness, postpartum hemorrhage rescue recording, and review of postpartum hemorrhage cases (detailed in the Intervention Description).
- Primary Outcome Measures
Name Time Method Rate of postpartum hemorrhage after vaginal delivery every month after intervention initiation Rate of postpartum hemorrhage after vaginal delivery (blood loss of ≥ 1000 ml within 24 hours after vaginal delivery)
- Secondary Outcome Measures
Name Time Method Rate of adherence to essential clinical practices at 6, 12, 18, and 24 months after intervention initiation Rate of adherence by obstetric staff to essential clinical practices for prevention and treatment of postpartum hemorrhage
Acceptability to the interventions at 24 months after intervention initiation The acceptability to the interventions will be assessed through a survey among the staff from experimental hospitals at 24 months after intervention initiation.
Rate of consequent adverse outcomes every month after intervention initiation Rate of consequent adverse outcomes associated with postpartum hemorrhage, including maternal death, blood transfusion, hysterectomy, stroke, organ failure, admittance to the intensive care unit \[ICU\], and any other complications associated with postpartum hemorrhage.
Trial Locations
- Locations (1)
Peking University Third Hospital
🇨🇳Beijing, Beijing, China