E-MOTIVE Trial

E-MOTIVE is a multi-country, parallel cluster randomised trial with a baseline control phase, along with mixed-methods and health economic evaluations.

Eighty secondary level health facilities will take part in the trial. Initially, all health facilities will enter a 7-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 7 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 (16 months). The proposed sample size for data collection will be 215,040 women.

This study has the following aims:

1. Evaluate the implementation of the E-MOTIVE intervention compared with usual care on clinical, implementation and resource use outcomes.

2. Assess the cost-effectiveness of the E-MOTIVE intervention compared with usual care from a public healthcare system perspective.

3. Develop, optimise and manualise an implementation strategy, with parallel process evaluation alongside the trial, ready for scaling-up of the E-MOTIVE intervention if found to be effective.

Our purpose is to integrate the evidence into WHO guidance for programmatic implementation of the E-MOTIVE intervention, if found to be effective, for global impact.

This trial will be conducted across 80 secondary level health facilities, across 5 low-and-middle-income countries (LMICs): Kenya, Tanzania, Nigeria, South Africa and Pakistan.

The research participants for this study will be the healthcare providers attending vaginal births in the study facilities. 

The recipients of the intervention will be women who have given birth vaginally and are at risk of PPH.

The E-MOTIVE intervention, which targets the healthcare providers consists of 3 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

3. An implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with action line, and MOTIVE emergency trolley and/or carry case.

A diagram of the E-MOTIVE intervention is shown below:

Below are the primary and secondary outcomes for the E-MOTIVE trial:

Primary outcome (a composite of 3 clinical outcomes):

1. Primary severe PPH defined as blood loss ≥1000 ml following a vaginal birth in the facility measured up to 2 hours postpartum
2. Postpartum laparotomy for bleeding until discharge from the health facility* 
3. Postpartum maternal death from bleeding until discharge from the health facility*

If any of the components occur, this will be deemed as positive for the primary outcome.   

Secondary clinical outcomes

The secondary clinical outcomes (where we expect to see a reduction if E-MOTIVE is effective) are based on the Core Outcome Set for PPH treatment, and are the following:

1. Laparotomy postpartum until discharge from the health facility*;
2. Laparotomy with compression sutures postpartum until discharge from the health facility*;
3. Laparotomy with arterial ligation postpartum until discharge from the health facility*;
4. Hysterectomy postpartum until discharge from the health facility*;
5. Hysterectomy postpartum  for bleeding until discharge from the health facility*;
6. All cause maternal mortality postpartum until discharge from the health facility*;
7. Blood loss (measured in ml) up to 24 hours postpartum;
8. Primary PPH defined as blood loss ≥500 ml up to 24 hours postpartum^†;
9. Duration of hospitalisation postpartum;
10. Duration of ICU hospitalisation postpartum until discharge from the health facility*;
11. Transfers to higher-level facility postpartum until discharge from the health facility;
12. All cause neonatal mortality postpartum until discharge from the health facility*;
13. Use of Non-pneumatic anti-shock garment (NASG) postpartum^†;
14. Use of uterine balloon tamponade postpartum until discharge from the health facility^†*;
15. Blood transfusion postpartum until discharge from the health facility^†*;
16. Blood transfusion for postpartum haemorrhage until discharge from the health facility^†*;
17. Intensive Care Unit (ICU) admissions postpartum until discharge from the health facility^†*;

^†Combined clinical and quality of care exploratory outcomes where we may observe an increase or a reduction if E-MOTIVE is effective

*In cases where a woman is transferred to another facility postpartum, discharge from the health facility relates to the facility the woman is transferred to [and the relevant outcomes will be obtained from the facility to which the woman was referred]. 

Secondary implementation outcomes

The key secondary implementation outcomes of special interest are 1) PPH detection (with the following numerator and denominator: women who objectively had PPH (blood loss ≥ 500 mL after weighing of the drape) and were diagnosed with PPH by the birth attendants divided by the total number of women who objectively had PPH, and 2) compliance with MOTIVE bundle (with the following numerator and denominator: women who objectively had PPH and were treated with the PPH bundle following a diagnosis of PPH by the birth attendants divided by the total number of women who objectively had PPH (blood loss ≥ 500 mL after weighing of the drape). Compliance with the MOTIVE bundle is defined as adherence with three core elements of the bundle: administration of oxytocic drugs, TXA and IV fluids. If all three core elements are administered when a PPH is diagnosed, this will be deemed positive for bundle compliance. If any of the three core elements are not administered when a PPH is diagnosed, then this will be deemed negative for bundle compliance. It is hypothesised that the causal mechanism underpinning the intervention is that it will increase the rate at which PPH is diagnosed; and that an increase in awareness of women suffering from PPH will subsequently lead to an increase in uptake in the interventions to stop PPH from progressing to severe consequences. This will ultimately lead to a reduction in the proportion of women suffering adverse outcomes from PPH. 

Other implementation outcomes are: 

1. PPH treatment (with the following numerator and denominator: women diagnosed with PPH by the birth attendants divided by the total of women having a vaginal birth in the health facility);

2. Bundle usage (with the following numerator and denominator: women treated with the PPH bundle following a diagnosis of PPH by the birth attendants divided by the total of women having a vaginal birth in the health facility);

3. Bundle usage for PPH (with the following numerator and denominator: women treated with the PPH bundle following a diagnosis of PPH by the birth attendant divided by the total of women diagnosed with PPH by the birth attendants);

4. Uterine massage;

5. Oxytocin use;

6. Misoprostol use;

7. TXA use;

8. Intravenous fluids use;

9. Examination of the genital tract;

10. Number of women receiving any treatment uterotonic;

11. Number of women requiring additional treatment interventions (not responding to the MOTIVE bundle).

Implementation outcomes will be reported with three denominators: the total study population; women diagnosed with PPH by the birth attendant; and women who objectively had PPH (blood loss ≥ 500 mL after weighing of the drape) unless otherwise specified. 

The data are routinely collected as part of normal clinical practice and women will not be approached for additional trial-specific data or follow up at any point.

 

 

Data entry for a new patient (for site teams): 

 

 

Editing a new record (for site teams): 

Cases of postpartum laparotomy and maternal death: 

Completing the Monthly Facility Form (for site teams):

Creating a data query (for hub teams): 

Answering a data query (for site teams):

Completion of data checks (for hub teams):

Monthly calibration of the baby weighing scales:

Using the blood collection drapes: 

Chief Investigator: Professor Arri Coomarasamy

Sponsor: University of Birmingham

Sponsor Ref: RG_19-231

Clinicaltrials.gov No.: NCT04341662

This study is funded by the Bill & Melinda Gates Foundation.

Current protocol: E-MOTIVE trial protocol v5.0