E-MOTIVE
Trial question
What is the role of bundled treatment in patients having vaginal delivery?
Study design
Multi-center
Open label
RCT
Population
99659 female patients.
Inclusion criteria: patients having vaginal delivery.
Key exclusion criteria: pre-existing implementation of early detection or bundled approach for treatment of postpartum hemorrhage.
Interventions
N=49101 bundled treatment (calibrated blood-collection drape for early detection of postpartum hemorrhage and a bundle of first-response treatments supported by an implementation strategy).
N=50558 usual care (various interventions in accordance with local or national guidelines).
Primary outcome
Composite of severe postpartum hemorrhage, laparotomy for bleeding, or maternal death from bleeding
1.6%
4.3%
4.3 %
3.2 %
2.1 %
1.1 %
0.0 %
Bundled
treatment
Usual
care
Significant
decrease ▼
NNT = 37
Significant decrease in severe postpartum hemorrhage, laparotomy for bleeding, or maternal death from bleeding (1.6% vs. 4.3%; RR 0.4, 95% CI 0.32 to 0.5).
Secondary outcomes
Significant increase in detection of postpartum hemorrhage (93.1% vs. 51.1%; RR 1.58, 95% CI 1.41 to 1.76).
Significant decrease in postpartum hemorrhage (8.5% vs. 16.7%; RR 0.51, 95% CI 0.44 to 0.6).
Significant increase in adherence to treatment bundle (91.2% vs. 19.4%; RR 4.94, 95% CI 3.88 to 6.28).
Safety outcomes
No significant difference in maternal deaths.
Conclusion
In patients having vaginal delivery, bundled treatment was superior to usual care with respect to the composite of severe postpartum hemorrhage, laparotomy for bleeding, or maternal death from bleeding.
Reference
Ioannis Gallos, Adam Devall, James Martin et al. Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage. N Engl J Med. 2023 Jul 6;389(1):11-21.
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