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Not yet recruiting NCT06684080

The Effectiveness of a Care Bundle to Prevent Postpartum Hemorrhage After Cesarean Delivery

No phase Interventional Cesarean Delivery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: A care bundle.
Who it may be relevant to
Registry conditions: Cesarean Delivery. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Cluster Randomized Trial on the Effectiveness of a Care Bundle to Prevent Postpartum Hemorrhage After Cesarean Delivery (Re-Team)

Overview

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

  • Other A 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

Primary outcome measures

  • Incidence of PPH [Time frame: Day 2]
Secondary outcome measures (7)
  • mean total calculated blood loss [Time frame: Day 2]
  • Estimated blood loss [Time frame: postpartum 24 hours]
  • Incidence of postpartum transfusion [Time frame: baseline]
  • Incidence of additional operations performed outside cesarean section [Time frame: baseline]
  • Incidence of transfer to intensive care unit [Time frame: baseline]
  • Incidence of maternal death from any cause [Time frame: Up to 42 days]
  • The adherence to the treatment bundle [Time frame: intraoperation and postpartum 24 hours]

Eligibility criteria

Inclusion criteria

  • Hospital level
  • Public hospitals
  • There are more than 100 cesarean deliveries per year
  • Patient level
  • Cesarean delivery
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06684080 · RE-TEAM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗