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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorDunjin Chen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Hospital level

Public hospitals

There are more than 100 cesarean deliveries per year

Patient level

Disqualifiers

Hospital level

Pregnant woman level 1. No blood routine results within 2 weeks before surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • A care bundle

    Other intervention

    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

Treatment groups

52,000 Participants
are divided into 2 treatment groups
Group A: Care bundle groupExperimental treatment 1 intervention
Group B: Usual care groupNo intervention 0 interventions

Trial outcomes

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 .

Time frame
Day 2

Secondary outcomes

1

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)\]

Time frame
Day 2
2

Estimated blood loss

Estimated intraoperative and postoperative blood loss at 24 hours

Time frame
postpartum 24 hours
3

Incidence of postpartum transfusion

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

Time frame
baseline
4

Incidence of additional operations performed outside cesarean section

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

Time frame
baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Dunjin Chen

Lead sponsor

The Third Affiliated Hospital of Guangzhou Medical University

Sponsor institution

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