Postpartum HemorrhageNCT05501106
Reducing Postpartum Hemorrhage After Vaginal Delivery
A study testing Integrated Improvement strategies in people with Postpartum Hemorrhage and Vaginal Delivery, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Postpartum Hemorrhage, Vaginal Delivery
- What is being tested?
- Integrated Improvement strategies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: 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.
- Conditions
- Postpartum Hemorrhage, Vaginal Delivery
- Being tested
- Integrated Improvement strategies
- Keywords
- Postpartum Hemorrhage, Vaginal Delivery, Quality Improvement
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Improvement strategiesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Integrated Improvement strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: every month after intervention initiation
Secondary outcomes (3)
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.
Measured: every month after intervention initiation
Rate of adherence to essential clinical practices
Rate of adherence by obstetric staff to essential clinical practices for prevention and treatment of postpartum hemorrhage
Measured: at 6, 12, 18, and 24 months after intervention initiation
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.
Measured: at 24 months after intervention initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Provincial Hospital, Chongqing Medical Center for Women and Children, Tianjin Central Hospital of Gynecology Obstetrics, Fujian Maternity and Child Health Hospital
- Responsible party
- Sponsor
- Investigators
- Yangyu Zhao, MD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501106
- Sponsor's protocol ID
- PKUTH22-08-09
- Status last verified
- Aug 2022
- First submitted
- 12 Aug 2022
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Improvement Program for the Management of Postpartum Hemorrhage After Vaginal Delivery: Protocol for A Matched-Pair, Cluster-Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05501106
- Acronym / sponsor ID
- PKUTH22-08-09
- Conditions
- Postpartum Hemorrhage, Vaginal Delivery
- Keywords
- Postpartum Hemorrhage, Vaginal Delivery, Quality Improvement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Shandong Provincial Hospital, Chongqing Medical Center for Women and Children, Tianjin Central Hospital of Gynecology Obstetrics, Fujian Maternity and Child Health Hospital
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Integrated Improvement strategiesThe 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). |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Improvement strategiesIntegrated 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. | Other | Experimental Arm |
Primary outcome
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)
3 secondary outcomes
Rate of consequent adverse outcomes
Time frame: every month after intervention initiation
Rate of adherence to essential clinical practices
Time frame: at 6, 12, 18, and 24 months after intervention initiation
Acceptability to the interventions
Time frame: at 24 months after intervention initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yangyu Zhao, MD principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Improvement strategies in people with Postpartum Hemorrhage and Vaginal Delivery, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huifeng Shi, Ph.D (15201277769, nsxm@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of postpartum hemorrhage after vaginal delivery (time frame: every month after intervention initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2022.