The global burden of postpartum haemorrhage01

WHO First Response Bundle for PPH. Where are we with the evidence?

The WHO first response bundle for reducing the burden of postpartum haemorrhage

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The E-MOTIVE & partners04

Challenges in managing postpartum haemorrhage proposed solutions

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Trial design0506 Progress to date and next steps

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Postpartum haemorrhage (PPH) is the leading cause of maternal death worldwide.

Postpartum haemorrhage (PPH) is commonly defined as a blood loss of 500 ml or more within 24 hours after birth.

Globally, nearly one quarter of all maternal deaths are associated with PPH. In most low-income countries, it is the main cause of maternal mortality.

1. The global burden of postpartum haemorrhage

99% of all maternal deaths occur in low- andmiddle-income countries (LMICs).

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PPH is common despite effective prevention

Women suffering PPH of 500 ml or more the risk of death or severe morbidity such as admission to intensive care unit was 100 times higher compared to women that did not suffer PPH (1.49%; 45/3,018 women versus 0.015%; 4/26,521)

1. The global burden of postpartum haemorrhage

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2. The WHO first response bundle for reducing the burden of postpartum haemorrhage

The WHO published “Recommendations for the Prevention and Treatment of Postpartum Hemorrhage” in 2012 to provide evidence-informed recommendations for managing PPH.

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2. The WHO first response bundle for reducing the burden of postpartum haemorrhage

Oxytocic drugs are the mainstay of prevention and treatment

Safe and effective manoeuvres to treat PPH such as uterine massage, examination for the source of PPH and initial fluid resuscitation with isotonic crystalloids are also recommended

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2. Interventions to reduce the burden of postpartum haemorrhage

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In 2016, the World Health Assembly and the United Nations Secretary-General updated the Every Woman, Every Childglobal strategy for ending all preventable deaths of women.

As part of this programme, the UN Commission on Life-Saving Commodities for Women and Children was set up to increase availability, expand access and improve utilisation of 13 life-saving commodities. Two of them were oxytocin and misoprostol for prevention and treatment of PPH.

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2. The WHO first response bundle for reducing the burden of postpartum haemorrhage

WHO produced a first response bundle after a technical consultation supported by BMGF

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3. Current challenges and solutions

1. PPH is often not detected early; thus life-saving treatment is not promptly initiated Solution: Early detection and treatment of PPH

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Blood loss increments (100ml)

95% confidence intervals

Only 26% of women with PPH received a treatment uterotonic drug

Even with severe PPH>1000ml 30% of women did not receive a treatment uterotonic drug

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3. Current challenges and solutions

2. Delayed or inconsistent use of interventions for PPH management Solution: the bundle

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3. Current challenges and solutions

3. Despite guideline dissemination, many care providers do not provide effective care Solution: Implementation strategy targeting Capabilities, Opportunities and Motivations for Behavior change (COM-B)

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- Lack of knowledge and skills - Lack of qualified staff- Lack of self-efficacy- Inappropriate expectations

- Lack of engagement or buy-in of staff or management- Lack of leadership or champions- Fear of reprisals - Lack of awareness

Physical – Work overload and workflow inefficiencies- Difficult access to resourcesSocial – Lack of teamwork and communication

Demonstrated barriers to bundle implementation

Proposed implementation strategies to address barriers to bundle implementation

- Simulation-based team learning at each site - Deliberate skills practice and repeated refresher training, facilitated by designated peers (peer-assisted learning)

- Introduction of local E-MOTIVE champions who encourage, support, and model bundle use- Introduction of calibrated drapes with trigger line to increase motivation for bundle use - Actionable data feedback to providers

Physical – Facilitated workflow through the introduction of MOTIVE emergency kits with all bundle components enabling easy and timely access to commodities Social – Peer assisted learning and champions

Capability

Motivation

Opportunity

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3. Current challenges and solutions

4. Lack of evidence and confidence that the proposed E-MOTIVE intervention is effective and cost-effective Solution: A cluster randomized trial with health economic analysis (the E-MOTIVE study)

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4. The E-MOTIVE & partners

Early detection strategy – the BRASSS-V drape

Validated as an early detection tool in India and Vietnam

$0.30-$1.20 per drape. Single use. Plastic, not biodegradable but biodegradable or reusable options available

Multi-country cluster randomized trial vs visual estimation found 17% decreased incidence of PPH morbidity/ mortality (2.1% vs 1.7%, not significant)

Cochrane review found calibrated drape vs visual estimation improved PPH detection (RR 1.86, 95% CI 1.11 to 3.11, high certainty)

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4. The E-MOTIVE & partners

Treatment bundle – the WHO MOTIVE bundle

WHO has carried out a technical consultation to design the MOTIVE bundle and has achieved wider consensus on its components. They are partnering with us to co-lead further development of the implementation strategy, in preparation for the large effectiveness trial.

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4. The E-MOTIVE & partners

Training – the Bleeding after Birth training package

We are partnering with jhpiego who will deliver the training package to health facilities. They have agreed to adapt their materials and training to accommodate the E-MOTIVE for local use.

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4. The E-MOTIVE & partners

University of Birmingham and the WHO collaborating centre for global women’s health are the grantees supported by BCTU for data collection, design and statistical analysis

BCTU is the largest clinical trials unit in the UK with expertise in global health trials.

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4. The E-MOTIVE & partners

Implementation science, qualitative researchers, global health experts, and Concept Foundation

We are partnering with implementation scientists from UCL who will be advising on the implementation methods adopted for rolling out E-MOTIVE, qualitative researchers for the formative work, academic institutions with expertise in global health and international NGO whose mission is to ensure access to high-quality affordable medicines.

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5. Trial design

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POPULATION

Cluster: Health facility is the randomisation unit.

-1000 to 5000 births a year

-Provide comprehensive obstetric care with ability to perform surgery for PPH

-Administratively and geographically distinct from each other

-Excluded if already detect early or use a bundled approach for PPH management

Research participants: All healthcare providers attending vaginal births

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5. Trial design

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INTERVENTION

1) a strategy for early detection of PPH, which allows triggering of the ‘first response’ treatment bundle

2) a ‘first response’ bundle called “MOTIVE”, based on the WHO guideline recommendations

3) an implementation strategy

CONTROL

Usual care with dissemination of the current guidelines

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5. Trial design

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OUTCOMES

Primary: Composite of the following three clinical outcomes:

-severe PPH defined as blood loss ≥1000 ml

-postpartum laparotomy for bleeding

-postpartum maternal death from bleeding

Key Secondary: 1) postpartum haemorrhage detection rate (defined as recording of diagnosis of PPH by birth attendant), and 2) compliance with the MOTIVE bundle

Secondary: blood transfusion, uterine tamponade, Intensive Care Unit admissions or higher-level facility transfers, and new-born deaths along with implementation and resource use outcomes

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5. Trial design

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Design: Multi-country, parallel cluster randomised trial with a baseline control phase, along with mixed-methods and health economic evaluations

Setting: Secondary level health facilities in Kenya, Tanzania, Nigeria, South Africa and Sri Lanka

Health facilities rather than patients are randomised

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5. Trial design

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337,920 women

80 health facilities (clusters)

E-MOTIVE map: http://bit.ly/emotivemap

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5. Trial design

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6. Progress and next steps

The E-MOTIVE study is fully operational and is acquiring pre-randomisation baseline data from 82 hospitals across four countries (Nigeria, Kenya, Tanzania and South Africa)

While the E-MOTIVE trial is progressing with baseline data collection, we are refining the intervention through ‘adaptive cycles’ which implement and test the intervention and the implementation strategy in three hospitals in each country

Study to report results by September 2023 on over 330,000 women

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Email: emotive@trials.bham.ac.uk Website: https://www.birmingham.ac.uk/emotive