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Reducing Postpartum Hemorrhage After Vaginal Delivery

Primary Purpose

Postpartum Hemorrhage, Vaginal Delivery

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Integrated Improvement strategies
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Hemorrhage focused on measuring Postpartum Hemorrhage, Vaginal Delivery, Quality Improvement

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

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:

-

Sites / Locations

  • Peking University Third Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Comparison Arm

Experimental Arm

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Rate of consequent adverse outcomes
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.
Rate of adherence to essential clinical practices
Rate of adherence by obstetric staff to essential clinical practices for prevention and treatment of postpartum hemorrhage
Acceptability to the interventions
The acceptability to the interventions will be assessed through a survey among the staff from experimental hospitals at 24 months after intervention initiation.

Full Information

First Posted
August 12, 2022
Last Updated
August 12, 2022
Sponsor
Peking University Third Hospital
Collaborators
Shandong Provincial Hospital, Chongqing Medical Center for Women and Children, Tianjin Central Hospital of Gynecology Obstetrics, Fujian Provincial Maternity and Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05501106
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
Collaborators
Shandong Provincial Hospital, Chongqing Medical Center for Women and Children, Tianjin Central Hospital of Gynecology Obstetrics, Fujian Provincial Maternity and Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage, Vaginal Delivery
Keywords
Postpartum Hemorrhage, Vaginal Delivery, Quality Improvement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
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.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Comparison Arm
Arm Type
No Intervention
Arm Description
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.
Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Integrated Improvement strategies
Intervention Description
Integrated improvement strategies include postpartum hemorrhage risk screening, hierarchical management and preparedness, postpartum hemorrhage rescue recording, and review of postpartum hemorrhage cases. 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. The Postpartum Hemorrhage Rescue Format will be asked to be used in each postpartum hemorrhage rescue to record the rescue process. 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.
Primary Outcome Measure Information:
Title
Rate of postpartum hemorrhage after vaginal delivery
Description
Rate of postpartum hemorrhage after vaginal delivery (blood loss of ≥ 1000 ml within 24 hours after vaginal delivery)
Time Frame
every month after intervention initiation
Secondary Outcome Measure Information:
Title
Rate of consequent adverse outcomes
Description
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.
Time Frame
every month after intervention initiation
Title
Rate of adherence to essential clinical practices
Description
Rate of adherence by obstetric staff to essential clinical practices for prevention and treatment of postpartum hemorrhage
Time Frame
at 6, 12, 18, and 24 months after intervention initiation
Title
Acceptability to the interventions
Description
The acceptability to the interventions will be assessed through a survey among the staff from experimental hospitals at 24 months after intervention initiation.
Time Frame
at 24 months after intervention initiation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
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: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huifeng Shi, Ph.D
Phone
15201277769
Email
nsxm@pku.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yangyu Zhao, MD
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China

12. IPD Sharing Statement

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Reducing Postpartum Hemorrhage After Vaginal Delivery

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