Every six minutes a mother dies from postpartum bleeding in low-resource countries, in the prime of her life and often leaving behind a young family.  The World Health Organization “Recommendations for the Prevention and Treatment of Postpartum Haemorrhage (PPH)” were published in 2012 to provide evidence-informed recommendations for managing postpartum bleeding. However, adherence to these recommendations is currently limited by late detection of PPH, delay or inconsistent use of PPH management interventions, many care providers not providing effective care, and limited scale-up and coverage of effective interventions.

We seek to to develop an affordable, practical, effective, acceptable, and equitable implementation strategy for the E-MOTIVE (Early detection and treatment of PPH, Uterine Massage, Oxytocin, Tranexamic acid IV fluids, Examination bundle)trial through the formative phase that seeks to understand the current perspectives and clinical management of PPH and the feasibility and acceptability of the E-MOTIVE intervention.

In this formative phase we propose to conduct a qualitative research, quantitative survey, and co-design workshop. The formative phase will use mixed-methods to understand how PPH is currently managed in the study settings, as a basis for tailoring and adapting the preliminary implementation intervention. We will also evaluate the quality of oxytocin and tranexamic acid in randomly sampled facilities prior to the intervention phase.

Background: Every six minutes a mother dies from postpartum bleeding in low-resource countries, in the prime of her life and often leaving behind a young family. Notably, when a mother dies during childbirth, her infant has less than a 20% chance of surviving past the first month.  The World Health Organization “Recommendations for the Prevention and Treatment of Postpartum Haemorrhage (PPH)” were published in 2012 to provide evidence-informed recommendations for managing PPH. However, adherence to these recommendations is currently limited by late detection of PPH, delay or inconsistent use of PPH management interventions, many care providers not providing effective care, and limited scale-up and coverage of effective interventions.

Objective: To develop an affordable, practical, effective, acceptable, and equitable implementation strategy for the E-MOTIVE (Early detection and treatment of PPH, Uterine Massage, Oxytocin, Tranexamic acid IV fluids, Examination bundle)trial through the formative phase that seeks to understand the current perspectives and clinical management of PPH and the feasibility and acceptability of the E-MOTIVE intervention.

Methods: In the formative phase we propose to conduct a qualitative research, quantitative survey, and co-design workshop. The formative phase will use mixed-methods to understand how PPH is currently managed in the study settings, as a basis for tailoring and adapting the preliminary implementation intervention. We will also evaluate the quality of oxytocin and tranexamic acid in randomly sampled facilities prior to the intervention phase.

Sampling and sample size: 

Maximum variation sampling will be used to achieve a stratified sample without random selection, and to ensure heterogeneity of research participants. This method uses pre-specified parameters to stratify the sample (n=730-800) and encourages the recruitment and sampling based on diversity. In each of the 80 study facilities, healthcare professionals will be sampled based on their cadre. We expect the type or designation of health care professionals to vary by facility, but at the minimum would include 9-10 providers per study facility as specialists (1-2), medical officers (3), and midwives/nurses (5).

In line with qualitative sample size guidelines and using purposive sampling, we will aim to recruit an initial sample of 10 to 15 participants per country across the three countries [22] (n= a total of 45 participants: n=15 participants per country, n=5 participants per health facility). We will analyse data in parallel with data collection, monitoring for thematic data saturation as we go, and adjust the sample size as necessary (e.g. discontinuing further interviews if saturation is deemed achieved). 

Data management and analysis:  All data will be collected through SmartSurvey software, encrypted using Secure Sockets Layer (SSL), stored and backed up on UK or EU-based servers within the European Economic Area (EEA), and will not be accessed nor shared without prior permission. Descriptive statistics will be calculated on all quantitative survey data. Cross-tabulation will be used to describe practices for PPH management, and perceptions of the E-MOTIVE intervention for PPH management. Results will be cross-tabulated and filtered to allow comparison of results by demographic subgroup, including job role, facility type or level, and country of origin. Qualitative data will be audio-recorded,  transcribed  and analysed using inductive thematic synthesis.

Significance:  Study findings will be used to systematically and transparently report the intervention development process; and finalise the manual of operations for the trial, intervention materials and protocols, including training.