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NCT Number: NCT06684080

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

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.

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Key information

Conditions

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

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A care bundle

Other
  • 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, 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

Primary outcomes

  1. Incidence of PPH

    Time frame: Day 2

    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 .

Secondary outcomes

  1. mean total calculated blood loss

    Time frame: Day 2

    Calculated estimated blood loss = estimated blood volume × (preoperative hematocrit - postoperative hematocrit)/preoperative hematocrit (where estimated blood volume (mL) = weight (Kg) × 85)]

  2. Estimated blood loss

    Time frame: postpartum 24 hours

    Estimated intraoperative and postoperative blood loss at 24 hours

  3. Incidence of postpartum transfusion

    Time frame: baseline

    infusion of RBC, plasma, platelet, or cryo et al

  4. Incidence of additional operations performed outside cesarean section

    Time frame: baseline

    Additional operations include B-Lnych, uterine artery suture, partial hysterectomy, hysterectomy et al

  5. Incidence of transfer to intensive care unit

    Time frame: baseline

    transfer to intensive care unit

  6. Incidence of maternal death from any cause

    Time frame: Up to 42 days

    maternal death from any cause

  7. The adherence to the treatment bundle

    Time frame: intraoperation and postpartum 24 hours

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Lizi M.D.

CONTACT

[email protected]

086-13265352553

Sponsors and collaborators

Lead sponsor

Dunjin Chen

Other

Registry information

Official study title

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

Acronym: RE-TEAM

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 12, 2024
Registry last updated
Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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