About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Hospital level
Public hospitals
There are more than 100 cesarean deliveries per year
Patient level
Disqualifiers
Hospital level
Pregnant woman level 1. No blood routine results within 2 weeks before surgery
Trial design
Parallel
Treatments tested in this trial
A care bundle
Other intervention1. 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
Treatment groups
Trial outcomes
Primary outcomes
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 .
Secondary outcomes
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)\]
Estimated blood loss
Estimated intraoperative and postoperative blood loss at 24 hours
Incidence of postpartum transfusion
infusion of RBC, plasma, platelet, or cryo et al
Incidence of additional operations performed outside cesarean section
Additional operations include B-Lnych, uterine artery suture, partial hysterectomy, hysterectomy et al
Locations
Sponsors and contacts
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Dunjin Chen
Lead sponsor
The Third Affiliated Hospital of Guangzhou Medical University
Sponsor institution
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