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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cesarean Delivery
• Intervention / Treatment: Other: A care bundle

• Study Type: Interventional
• Enrollment (Estimated): 52000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lizi M.D.; Phone Number: 086-13265352553; Email: 2022390064@gzhmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care group; 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.
Experimental: Care bundle group; 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: Lack of uterine contractions; Persistent bleeding; Shock index (heart rate/systolic blood pressure) was greater than 0.9 Initiate the following protocols①, ②, ③, ④Maintain uterus tone (Administration of Oxytocin and second-line medications to promote uterine contraction)Intravenous infusion ③ Administered tranexamic acidMulti-methods and Multi-disciplinary	Other: A care bundle; Risk evaluation for PPH and Reserve plan;; Assess blood loss using Estimated Blood Loss Form and amnion fluid collection drape;; 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, ④Maintain 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Dunjin Chen

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: November 11, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 31, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: treatment; Detection; Postpartum Hemorrhage; Randomized trial; cesarean delivery
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Puerperal Disorders; Uterine Hemorrhage; Postpartum Hemorrhage; Hemorrhage
• Other Study ID Numbers: RE-TEAM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No