Clinical trial NCT05501106: Reducing Postpartum Hemorrhage After Vaginal Delivery
Official title: Quality Improvement Program for the Management of Postpartum Hemorrhage After Vaginal Delivery: Protocol for A Matched-Pair, Cluster-Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postpartum Hemorrhage
Vaginal Delivery
Keywords: Postpartum Hemorrhage
Vaginal Delivery
Quality Improvement
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Shandong Provincial Hospital
name: Chongqing Medical Center for Women and Children
name: Tianjin Central Hospital of Gynecology Obstetrics
name: Fujian Provincial Maternity and Children's Hospital
First posted: 2022-08-15
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: The study will be conducted at 50 hospitals in Shandong, Beijing, Tianjin, Chongqing and Fujian provinces, which are distributed in eastern and western China.

Due to the nature of the program, the unit of intervention will be at the hospital level. Hence, the recruitment plan will include selecting maternity hospitals and enrolling them into either the experimental or comparison arms.

All hospitals registered on the NCHQMO monitoring platform are required to report data of obstetric quality control indicators every month and the registration has no limitation on the hospital size, medical care level or regional distribution. The NCHQMO and the provincial centers of healthcare quality management in obstetrics in five provinces cooperate to recruit maternity hospitals from the hospitals registered on the NCHQMO monitoring platform. Each of the five provinces will contribute 10 maternity hospitals (two hospitals in each facility type: secondary public general hospitals, secondary public specialty hospitals, tertiary public general hospitals, tertiary public specialty hospitals, and private hospitals), leading to a total of 50 hospitals.

Inclusion Criteria (for hospitals):

* 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:

-

Primary outcomes:
measure: Rate of postpartum hemorrhage after vaginal delivery
timeFrame: every month after intervention initiation
Secondary outcomes:
measure: Rate of consequent adverse outcomes
timeFrame: every month after intervention initiation
measure: Rate of adherence to essential clinical practices
timeFrame: at 6, 12, 18, and 24 months after intervention initiation
measure: Acceptability to the interventions
timeFrame: at 24 months after intervention initiation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Yangyu Zhao, MD
role: PRINCIPAL_INVESTIGATOR
References: