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

NCT ID: NCT06684080

Last Updated: 2025-01-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2027-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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:

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

Group Type: EXPERIMENTAL

A care bundle

Intervention Type: 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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

A care bundle

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

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dunjin Chen

OTHER

Sponsor Role: lead

Responsible Party

Dunjin Chen

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Lizi M.D.

Role: CONTACT

2022390064@gzhmu.edu.cn

086-13265352553

Other Identifiers

RE-TEAM

Identifier Type: -

Identifier Source: org_study_id