Cesarean Delivery
Conditions
Keywords
Postpartum Hemorrhage, cesarean delivery, Randomized trial, Detection, treatment
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.
Interventions
OTHERA care bundle
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
Sponsors
Dunjin Chen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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)\] |
| 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 |
| Incidence of transfer to intensive care unit | baseline | transfer to intensive care unit |
Contacts
Primary ContactLizi M.D.
Outcome results
None listed