Cesarean DeliveryRE-TEAMNCT06684080
The Effectiveness of a Care Bundle to Prevent Postpartum Hemorrhage After Cesarean Delivery
A study testing A care bundle in people with Cesarean Delivery, run by Dunjin Chen.
Trial summary
Delays in the detection or inconsistent use of effective interventions of postpartum hemorrhage can result in complications or death. We designed a cluster-randomized trial to assess a multi-component strategy for the detection and treatment of postpartum hemorrhage after cesarean delivery. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cesarean Delivery
- What is being tested?
- A care bundle
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hospital level
- Public hospitals
- There are more than 100 cesarean deliveries per year
- Patient level
- Cesarean delivery
- Sign informed consent
Who cannot join
- Hospital level
- 1. Data verification information cannot be provided
- Pregnant woman level 1. No blood routine results within 2 weeks before surgery
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Cluster Randomized Trial on the Effectiveness of a Care Bundle to Prevent Postpartum Hemorrhage After Cesarean Delivery (Re-Team)
Delays in the detection or inconsistent use of effective interventions of postpartum hemorrhage can result in complications or death. We designed a cluster-randomized trial to assess a multi-component strategy for the detection and treatment of postpartum hemorrhage after cesarean delivery.
- Conditions
- Cesarean Delivery
- Being tested
- A care bundle
- Keywords
- Postpartum Hemorrhage, cesarean delivery, Randomized trial, Detection, treatment
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A care bundleOther
- Risk evaluation for PPH and Reserve plan;
- Assess blood loss using Estimated Blood Loss Form and amnion fluid collection drape;
- Satisfy any of the following conditions: i. If the estimated blood loss reaches 500ml but is less than 1000ml, and any of the following abnormal indicators are present; ii. If the estimated blood loss reaches 1000ml, no other indicators need to be considered: 1） Lack of uterine contractions 2） Persistent bleeding 3）Shock index (heart rate/systolic blood pressure) was greater than 0.9 Initiate the following protocols①, ②, ③, ④
- Maintain uterus tone (Administration of Oxytocin and second-line medications to promote uterine contraction)
- Intravenous infusion ③ Administered tranexamic acid ④ Multi-methods and Multi-disciplinary
| Study group | Role | What they receive |
|---|---|---|
| Care bundle group | Experimental | 1. Risk evaluation for PPH and Reserve plan; 2.Assess blood loss using Estimated Blood Loss Form and amnion fluid collection drape; 3. Satisfy any of the following conditions: i. If the estimated blood loss reaches 500ml but is less than 1000ml, and any of the following abnormal indicators are present; ii. If the estimated blood loss reaches 1000ml, no other indicators need to be considered:
1. Lack of uterine contractions
2. Persistent bleeding
3. Shock index (heart rate/systolic blood pressure) was greater than 0.9 Initiate the following protocols①, ②, ③, ④
* Maintain uterus tone (Administration of Oxytocin and second-line medications to promote uterine contraction)
* Intravenous infusion ③ Administered tranexamic acid
* Multi-methods and Multi-disciplinary Receives: Other: A care bundle |
| Usual care group | No intervention | The usual care group does not receive a PPH risk assessment and estimates blood loss visually and used various interventions for postpartum hemorrhage in accordance with local or national guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PPH
defined by a calculated estimated blood loss > 1000 mL [Calculated estimated blood loss = estimated blood volume × (preoperative hematocrit - postoperative hematocrit)/preoperative hematocrit (where estimated blood volume (mL) = weight (Kg) × 85)] or red blood cell (RBC) transfusion before day 2 postpartum .
Measured: Day 2
Secondary outcomes (7)
mean total calculated blood loss
Calculated estimated blood loss = estimated blood volume × (preoperative hematocrit - postoperative hematocrit)/preoperative hematocrit (where estimated blood volume (mL) = weight (Kg) × 85)]
Measured: Day 2
Estimated blood loss
Estimated intraoperative and postoperative blood loss at 24 hours
Measured: postpartum 24 hours
Incidence of postpartum transfusion
infusion of RBC, plasma, platelet, or cryo et al
Measured: baseline
Incidence of additional operations performed outside cesarean section
Additional operations include B-Lnych, uterine artery suture, partial hysterectomy, hysterectomy et al
Measured: baseline
Incidence of transfer to intensive care unit
transfer to intensive care unit
Measured: baseline
Incidence of maternal death from any cause
maternal death from any cause
Measured: Up to 42 days
The adherence to the treatment bundle
defined adherence to at least four core bundle elements: risk evaluation for PPH and reserve plan, maintaining uterus tone (administration of oxytocin and second-line medications to promote uterine contraction), intravenous infusion, administered tranexamic acid
Measured: intraoperation and postpartum 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean DeliveryStudies 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
- Masking
- None (open label)
- Enrolment
- 52,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dunjin Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dunjin Chen, The Third Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684080
- Sponsor's protocol ID
- RE-TEAM
- Acronym
- RE-TEAM
- Status last verified
- Dec 2024
- First submitted
- 29 Oct 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Trial on the Effectiveness of a Care Bundle to Prevent Postpartum Hemorrhage After Cesarean Delivery (Re-Team)
- ClinicalTrials.gov ID
- NCT06684080
- Acronym / sponsor ID
- RE-TEAM / RE-TEAM
- Conditions
- Cesarean Delivery
- Keywords
- Postpartum Hemorrhage, cesarean delivery, Randomized trial, Detection, treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52,000 participants (estimated)
- Lead sponsor
- Dunjin ChenUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 12 Nov 2024 (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.
Delays in the detection or inconsistent use of effective interventions of postpartum hemorrhage can result in complications or death. We designed a cluster-randomized trial to assess a multi-component strategy for the detection and treatment of postpartum hemorrhage after cesarean delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care bundle group | Experimental | Other: A care bundle1. Risk evaluation for PPH and Reserve plan; 2.Assess blood loss using Estimated Blood Loss Form and amnion fluid collection drape; 3. Satisfy any of the following conditions: i. If the estimated blood loss reaches 500ml but is less than 1000ml, and any of the following abnormal indicators are present; ii. If the estimated blood loss reaches 1000ml, no other indicators need to be considered: 1. Lack of uterine contractions 2. Persistent bleeding 3. Shock index (heart rate/systolic blood pressure) was greater than 0.9 Initiate the following protocols①, ②, ③, ④ * Maintain uterus tone (Administration of Oxytocin and second-line medications to promote uterine contraction) * Intravenous infusion ③ Administered tranexamic acid * Multi-methods and Multi-disciplinary |
| Usual care group | No intervention | –The usual care group does not receive a PPH risk assessment and estimates blood loss visually and used various interventions for postpartum hemorrhage in accordance with local or national guidelines. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Hospital level
- Patient level
Key exclusion criteria (3 listed)
- Hospital level
- 1. Data verification information cannot be provided
- Pregnant woman level 1. No blood routine results within 2 weeks before surgery
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 |
|---|---|---|
| A care bundle1. Risk evaluation for PPH and Reserve plan; 2. Assess blood loss using Estimated Blood Loss Form and amnion fluid collection drape; 3. Satisfy any of the following conditions: i. If the estimated blood loss reaches 500ml but is less than 1000ml, and any of the following abnormal indicators are present; ii. If the estimated blood loss reaches 1000ml, no other indicators need to be considered: 1） Lack of uterine contractions 2） Persistent bleeding 3）Shock index (heart rate/systolic blood pressure) was greater than 0.9 Initiate the following protocols①, ②, ③, ④ * Maintain uterus tone (Administration of Oxytocin and second-line medications to promote uterine contraction) * Intravenous infusion ③ Administered tranexamic acid ④ Multi-methods and Multi-disciplinary | Other | Care bundle group |
Primary outcome
Incidence of PPH
Time frame: Day 2
defined by a calculated estimated blood loss > 1000 mL [Calculated estimated blood loss = estimated blood volume × (preoperative hematocrit - postoperative hematocrit)/preoperative hematocrit (where estimated blood volume (mL) = weight (Kg) × 85)] or red blood cell (RBC) transfusion before day 2 postpartum .
7 secondary outcomes
mean total calculated blood loss
Time frame: Day 2
Estimated blood loss
Time frame: postpartum 24 hours
Incidence of postpartum transfusion
Time frame: baseline
Incidence of additional operations performed outside cesarean section
Time frame: baseline
Incidence of transfer to intensive care unit
Time frame: baseline
Incidence of maternal death from any cause
Time frame: Up to 42 days
The adherence to the treatment bundle
Time frame: intraoperation and postpartum 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing A care bundle in people with Cesarean Delivery, run by Dunjin Chen.
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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lizi M.D. (086-13265352553, 2022390064@gzhmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of PPH (time frame: Day 2). 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 1 Jan 2025.