Quality Improvement Program for the Management of Postpartum Hemorrhage After Vaginal Delivery: Protocol for A Matched-Pair, Cluster-Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Rate of postpartum hemorrhage after vaginal delivery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 49 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion 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
- Not provided
Arms & Interventions
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.
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).
Intervention: Integrated Improvement strategies (Other)
Outcomes
Primary Outcomes
Rate of postpartum hemorrhage after vaginal delivery
Time Frame: every month after intervention initiation
Rate of postpartum hemorrhage after vaginal delivery (blood loss of ≥ 1000 ml within 24 hours after vaginal delivery)
Secondary Outcomes
- 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)
- Rate of consequent adverse outcomes(every month after intervention initiation)