- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05501106
Reducing Postpartum Hemorrhage After Vaginal Delivery
Quality Improvement Program for the Management of Postpartum Hemorrhage After Vaginal Delivery: Protocol for A Matched-Pair, Cluster-Randomized Controlled Trial
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Huifeng Shi, Ph.D
- Phone Number: 15201277769
- Email: nsxm@pku.edu.cn
Study Locations
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Beijing
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Beijing, Beijing, China, 100191
- Peking University Third Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 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.
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Experimental: 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).
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Integrated improvement strategies include postpartum hemorrhage risk screening, hierarchical management and preparedness, postpartum hemorrhage rescue recording, and review of postpartum hemorrhage cases.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of postpartum hemorrhage after vaginal delivery
Time Frame: every month after intervention initiation
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Rate of postpartum hemorrhage after vaginal delivery (blood loss of ≥ 1000 ml within 24 hours after vaginal delivery)
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every month after intervention initiation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of consequent adverse outcomes
Time Frame: every month after intervention initiation
|
Rate of consequent adverse outcomes associated with postpartum hemorrhage, including maternal death, blood transfusion, hysterectomy, stroke, organ failure, admittance to the intensive care unit [ICU], and any other complications associated with postpartum hemorrhage.
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every month after intervention initiation
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Rate of adherence to essential clinical practices
Time Frame: at 6, 12, 18, and 24 months after intervention initiation
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Rate of adherence by obstetric staff to essential clinical practices for prevention and treatment of postpartum hemorrhage
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at 6, 12, 18, and 24 months after intervention initiation
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Acceptability to the interventions
Time Frame: at 24 months after intervention initiation
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The acceptability to the interventions will be assessed through a survey among the staff from experimental hospitals at 24 months after intervention initiation.
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at 24 months after intervention initiation
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yangyu Zhao, MD, Peking University Third Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PKUTH22-08-09
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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