Reducing Postpartum Hemorrhage After Vaginal Delivery

NCT ID: NCT05501106

Last Updated: 2022-08-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-12-31

Brief Summary

Postpartum hemorrhage is the primary cause threatening the life safety of pregnant women in the world and China, and also the main cause of hysterectomy for women giving birth. The management of postpartum hemorrhage necessitates a coordinated multidisciplinary approach but limited available data on this issue. This program aims to evaluate the effectiveness and acceptability of the integrated strategies, on postpartum hemorrhage after vaginal delivery and relevant clinical practice, in response to the increasing incidence of postpartum hemorrhage and its long-standing threaten to the life safety of pregnant women.

A matched-pair, cluster-randomized controlled trial will be conducted among 50 maternity hospitals with at least 500 vaginal deliveries annually from five provinces in China. Recruited hospitals will be randomly assigned in a 1:1 ratio to either the experimental or comparison arms. All hospitals will receive general interventions, including: recommendation for implementing quality improvement programs to reduce vaginal delivery complications; trainings on obstetric quality management and clinical skills (3 times a year); and monitoring postpartum hemorrhage rate every month. The hospitals in the experimental group will additionally implement integrated improvement strategies which include postpartum hemorrhage risk screening, hierarchical management and preparedness, rescue recording, and case review. The primary outcome is the rate of postpartum hemorrhage, and the secondary outcomes include rate of consequent adverse outcomes, adherence to all known best practices, and staff acceptability to the interventions. These outcomes will be measured and compared between the experimental and control groups. Both intention-to-treat and per-protocol analyses will be performed.

Conditions

Postpartum Hemorrhage; Vaginal Delivery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Comparison Arm

All hospitals will receive general interventions (comparison program), including: recommendation for implementing quality improvement programs to reduce vaginal delivery complications; trainings on obstetric quality management and clinical skills on the prediction and treatment of vaginal delivery complications (3 times a year); monitoring postpartum hemorrhage after vaginal delivery and reporting data to the NCHQMO by monitoring platform every month.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental Arm

The hospitals in the experimental group will receive general interventions and additionally implement integrated improvement strategies which include postpartum hemorrhage risk screening, hierarchical management and preparedness, postpartum hemorrhage rescue recording, and review of postpartum hemorrhage cases (detailed in the Intervention Description).

Group Type: EXPERIMENTAL

Integrated Improvement strategies

Intervention Type: OTHER

Integrated improvement strategies include postpartum hemorrhage risk screening, hierarchical management and preparedness, postpartum hemorrhage rescue recording, and review of postpartum hemorrhage cases.

1. A checklist (named as Risk Assessment and Preparedness for Postpartum Hemorrhage (Traffic Light in Delivery Room)) will be used in each virginal delivery to help obstetric staff and teams identify risk factors after admission, before and during labor, and improve the adherence to all known best practices.

2. The Postpartum Hemorrhage Rescue Format will be asked to be used in each postpartum hemorrhage rescue to record the rescue process.

3. Each case of postpartum hemorrhage exceeding 1000 ml will be reviewed. We will convene a QI Panel and a Task Force to assist the hospitals in postpartum hemorrhage case review and quality improvement strategy development.

Interventions

Integrated Improvement strategies

Integrated improvement strategies include postpartum hemorrhage risk screening, hierarchical management and preparedness, postpartum hemorrhage rescue recording, and review of postpartum hemorrhage cases.

1. A checklist (named as Risk Assessment and Preparedness for Postpartum Hemorrhage (Traffic Light in Delivery Room)) will be used in each virginal delivery to help obstetric staff and teams identify risk factors after admission, before and during labor, and improve the adherence to all known best practices.

2. The Postpartum Hemorrhage Rescue Format will be asked to be used in each postpartum hemorrhage rescue to record the rescue process.

3. Each case of postpartum hemorrhage exceeding 1000 ml will be reviewed. We will convene a QI Panel and a Task Force to assist the hospitals in postpartum hemorrhage case review and quality improvement strategy development.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• geographical location of the maternity hospitals within study provinces;
• being registered on the NCHQMO monitoring platform;
• willingness of the hospital leaders and staff to participate in the study;
• having at least 500 vaginal deliveries annually;
• having no potentially confounding ongoing research.

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role: collaborator

Chongqing Medical Center for Women and Children

OTHER

Sponsor Role: collaborator

Tianjin Central Hospital of Gynecology Obstetrics

OTHER

Sponsor Role: collaborator

Fujian Provincial Maternity and Children's Hospital

UNKNOWN

Sponsor Role: collaborator

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yangyu Zhao, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

Peking University Third Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Huifeng Shi, Ph.D

Role: CONTACT

nsxm@pku.edu.cn

15201277769

Other Identifiers

PKUTH22-08-09

Identifier Type: -

Identifier Source: org_study_id