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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52,000
1. Risk evaluation for PPH and Reserve plan; 2. Assess blood loss using Estimated Blood Loss Form and amnion fluid collection drape; 3. Satisfy any of the following conditions: i. If the estimated blood loss reaches 500ml but is less than 1000ml, and any of the following abnormal indicators are present; ii. If the estimated blood loss reaches 1000ml, no other indicators need to be considered: 1） Lack of uterine contractions 2） Persistent bleeding 3）Shock index (heart rate/systolic blood pressure) was greater than 0.9 Initiate the following protocols①, ②, ③, ④ * Maintain uterus tone (Administration of Oxytocin and second-line medications to promote uterine contraction) * Intravenous infusion ③ Administered tranexamic acid ④ Multi-methods and Multi-disciplinary
Incidence of PPH
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 .
Time frame: Day 2
mean total calculated blood loss
Calculated estimated blood loss = estimated blood volume × (preoperative hematocrit - postoperative hematocrit)/preoperative hematocrit (where estimated blood volume (mL) = weight (Kg) × 85)\]
Time frame: Day 2
Estimated blood loss
Estimated intraoperative and postoperative blood loss at 24 hours
Time frame: postpartum 24 hours
Incidence of postpartum transfusion
infusion of RBC, plasma, platelet, or cryo et al
Time frame: baseline
Incidence of additional operations performed outside cesarean section
Additional operations include B-Lnych, uterine artery suture, partial hysterectomy, hysterectomy et al
Time frame: baseline
Incidence of transfer to intensive care unit
transfer to intensive care unit
Time frame: baseline
Incidence of maternal death from any cause
maternal death from any cause
Time frame: Up to 42 days
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The adherence to the treatment bundle
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
Time frame: intraoperation and postpartum 24 hours