Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Care bundle group | Experimental | 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:
|
|
| Usual care group | No Intervention | The usual care group does not receive a PPH risk assessment and estimates blood loss visually and used various interventions for postpartum hemorrhage in accordance with local or national guidelines. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A care bundle | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 . | Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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)] | Day 2 |
| Estimated blood loss |
Not provided
Inclusion Criteria:
Hospital level
Patient level
Exclusion Criteria:
Hospital level
1. Data verification information cannot be provided
Pregnant woman level 1. No blood routine results within 2 weeks before surgery
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lizi M.D. | Contact | 086-13265352553 | 2022390064@gzhmu.edu.cn |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Estimated intraoperative and postoperative blood loss at 24 hours |
| postpartum 24 hours |
| Incidence of postpartum transfusion | infusion of RBC, plasma, platelet, or cryo et al | baseline |
| Incidence of additional operations performed outside cesarean section | Additional operations include B-Lnych, uterine artery suture, partial hysterectomy, hysterectomy et al | baseline |
| Incidence of transfer to intensive care unit | transfer to intensive care unit | baseline |
| Incidence of maternal death from any cause | maternal death from any cause | Up to 42 days |
| 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 | intraoperation and postpartum 24 hours |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |