The study is about early detection of excess bleeding after delivery and its treatment using the World Health Organization (WHO) ‘first response’ bundle in  a cluster randomised trial with health economic analysis and mixed-methods evaluation.

In this study we aim to evaluate the effect of  implementation of early detection and the use of WHO MOTIVE ‘first response’ treatment bundle for PPH on clinical, implementation and resource use outcomes through mixed-methods and carry out a health economic evaluation from the public healthcare system perspective.

The study is a mtulti-country, parallel cluster randomised trial with a baseline control phase, along with mixed-methods and health economic evaluations whoich will be conducted in secondary level health facilities in Kenya, Tanzania, Nigeria, South Africa, Sri Lanka, and India. 

The E-MOTIVE intervention consists of three elements: 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 and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination & Escalation; and 3) an implementation strategy, focusing on simulation-based training, peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with action line, and MOTIVE emergency kits.

The Control will be usual care with dissemination of the current guidelines.

The primary outcomes will be a combination of three clinical outcomes: severe PPH defined as blood loss ≥1000 ml or postpartum laparotomy for bleeding or postpartum maternal death from bleeding. The secondary outcomes will constitute: Blood transfusion, uterine tamponade, Intensive Care Unit admissions or higher level facility transfers, and newborn deaths along with implementation and resource use outcomes.

Mixed methods work During the 11-month baseline phase, we will refine and optimise the E-MOTIVE implementation strategy by piloting it in one to two facilities per country over up to two adaptive cycles for addressing barriers and enablers to delivery and implementation, ahead of the intervention phase. 

Process evaluation during the intervention phase We will conduct a mixed-methods process evaluation to assess the extent to which the E-MOTIVE intervention has been implemented as intended. The implementation outcomes of interest are fidelity, adoption, adaptation, acceptability, and sustainability, as well as contextual influences and barriers and enablers to implementation. 

Health economics We plan to assess the cost-effectiveness of the E-MOTIVE intervention compared with usual care from a public healthcare system perspective for each country, as measured by incremental cost-effectiveness ratios for a) severe PPH prevented, b) laparotomy for PPH prevented, c) death from PPH avoided, and (d) quality-adjusted life-years prevented.

Title Early detection of PPH and treatment using the WHO MOTIVE ‘first response’ bundle: a cluster randomised trial with health economic analysis and mixed-methods evaluation. 

Aim To evaluate the implementation of early detection and the use of WHO MOTIVE ‘first response’ treatment bundle for PPH on clinical, implementation and resource use outcomes. We will evaluate the implementation through mixed-methods and carry out a health economic evaluation from the public healthcare system perspective.

Study 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, Sri Lanka, and India.

Population Cluster: Health facility is the randomisation unit. Health facilities are eligible for inclusion if they are able to provide comprehensive obstetric and newborn care for 750 to 5000 births a year. Research participants: All healthcare providers attending vaginal births in the study facilities. 

Intervention The E-MOTIVE intervention consists of three elements: 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 and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination & Escalation; and 3) an implementation strategy, focusing on simulation-based training, peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with action line, and MOTIVE emergency kits.

Control Usual care with dissemination of the current guidelines.

Outcomes Primary: Composite of the following three clinical outcomes: severe PPH defined as blood loss ≥1000 ml or postpartum laparotomy for bleeding or postpartum maternal death from bleeding. Secondary: Blood transfusion, uterine tamponade, Intensive Care Unit admissions or higher level facility transfers, and newborn deaths along with implementation and resource use outcomes.

Randomisation and sample size. 80 health facilities will take part in the study. Initially, all health facilities will enter an 11-month baseline period in which they will be following usual care. After this, we will randomise 40 of the 80 health facilities to the E-MOTIVE intervention for 11 months, allowing two months for transition. The other 40 health facilities will continue to follow usual care as per the baseline period for the entire trial duration (2 years).The total sample size for the study would be 337,920 women. This sample size is expected to have over 90% power to detect a 25% relative reduction in the primary outcome from 2% to 1.5% after allowing for clustering. The number of clusters has been inflated by 10% to allow for drop out of health facilities and for varying cluster sizes. Randomisation will use a minimisation algorithm to balance centres by the number of births per hospital, the characteristics of health facilities, country and the health facility rate of the composite primary outcome during the baseline phase. 

Mixed methods work During the 11-month baseline phase, we will refine and optimise the E-MOTIVE implementation strategy by piloting it in one to two facilities per country over up to two adaptive cycles for addressing barriers and enablers to delivery and implementation, ahead of the intervention phase. 

Process evaluation during the intervention phase We will conduct a mixed-methods process evaluation to assess the extent to which the E-MOTIVE intervention has been implemented as intended. The implementation outcomes of interest are fidelity, adoption, adaptation, acceptability, and sustainability, as well as contextual influences and barriers and enablers to implementation. 

Health economics We plan to assess the cost-effectiveness of the E-MOTIVE intervention compared with usual care from a public healthcare system perspective for each country, as measured by incremental cost-effectiveness ratios for a) severe PPH prevented, b) laparotomy for PPH prevented, c) death from PPH avoided, and (d) quality-adjusted life-years prevented.