Reducing Postpartum Hemorrhage After Vaginal Delivery

NCT05501106 | Unknown DMC

• 1 other identifier: PKUTH22-08-09
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Postpartum Hemorrhage; Vaginal Delivery; Quality Improvement

Outcome Measures

Primary Outcomes (1)

• Rate of postpartum hemorrhage after vaginal delivery

  Rate of postpartum hemorrhage after vaginal delivery (blood loss of ≥ 1000 ml within 24 hours after vaginal delivery)

  every month after intervention initiation

Secondary Outcomes (3)

• Rate of consequent adverse outcomes

  every month after intervention initiation

• Rate of adherence to essential clinical practices

  at 6, 12, 18, and 24 months after intervention initiation

• Acceptability to the interventions

  at 24 months after intervention initiation

Study Arms (2)

Comparison Arm

NO INTERVENTION

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.

Experimental Arm

EXPERIMENTAL

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).

Other: Integrated Improvement strategies

Interventions

Integrated Improvement strategies 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.

Experimental Arm

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Shandong Provincial Hospital: collaborator
• Chongqing Medical Center for Women and Children: collaborator
• Tianjin Central Hospital of Gynecology Obstetrics: collaborator
• Fujian Provincial Maternity and Children's Hospital: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

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

Study Officials

• Yangyu Zhao, MD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huifeng Shi, Ph.D

CONTACT

15201277769; nsxm@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Maternity hospital allocation will be concealed from the research assistant who will enroll and assign the hospitals. Because the quality improvement plans proposed by the NCHQMO are publicly released, it will not be possible to blind the hospital staff to the allocation. The investigators collecting information of invention implementation and acceptability will not be masked to the allocation, while the investigators assessing clinical practices and health outcomes and data statistical analysts will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 15, 2022
• Study Start: September 1, 2022
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 15, 2022

Record last verified: 2022-08

Locations

CN (1)