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

NCT06684080 | Not Yet Recruiting DMC

• 1 other identifier: RE-TEAM
• Study Type: interventional
• Target: 52,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cesarean Delivery

Keywords

Postpartum Hemorrhage; cesarean delivery; Randomized trial; Detection; treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• mean total calculated blood loss

  Day 2

• Estimated blood loss

  postpartum 24 hours

• Incidence of postpartum transfusion

  baseline

• Incidence of additional operations performed outside cesarean section

  baseline

• Incidence of transfer to intensive care unit

  baseline

Study Arms (2)

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: 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

Other: A care bundle

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.

Interventions

A care bundle OTHER

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

Care bundle group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Hospital level
• \. Data verification information cannot be provided
• Pregnant woman level 1. No blood routine results within 2 weeks before surgery

Sponsors & Collaborators

• Dunjin Chen: lead

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lizi M.D.

CONTACT

086-13265352553; 2022390064@gzhmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: November 12, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share