The Effectiveness of a Care Bundle to Prevent Postpartum Hemorrhage After Cesarean Delivery (RE-TEAM)

Dunjin Chen

Status: Not yet enrolling

Conditions: Cesarean Delivery

Treatments: Other: A care bundle

Study type: Interventional

Funder types: Other

Identifiers

NCT06684080

RE-TEAM

Details and patient eligibility

About

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.

Enrollment: 52,000 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52,000 participants in 2 patient groups

Care bundle group

Experimental group

Description:

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 * Multi-methods and Multi-disciplinary

Treatment:

Other: A care bundle

Usual care group

No Intervention group

Description:

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.