By Oluwadamilola Sosanya, BS, and Maria I. Rodriguez, MD, MPH
Oluwadamilola Sosanya is an MD candidate, Oregon Health & Science University, Portland, and Dr. Rodriguez is Professor, Obstetrics & Gynecology, Division of Complex Family Planning, Department of Obstetrics & Gynecology, Oregon Health & Science University, Portland.
SYNOPSIS: This international, parallel, cluster-randomized trial assigned 80 secondary-level hospitals in four African countries to evaluate a multicomponent intervention for early detection and treatment of postpartum hemorrhage (PPH) vs. usual care following a vaginal birth. The intervention group had 60% less severe PPH cases (> 1 L blood loss) than the usual care cohort.
SOURCE: Gallos I, Devall A, Martin J, et al. Randomized trial of early detection and treatment of postpartum hemorrhage. N Engl J Med 2023;389:11-21.
Postpartum hemorrhage (PPH), defined as at least 500 mL of blood loss following a vaginal birth, is a leading cause of maternal mortality and morbidity globally.1 Despite evidence-based guidelines and known strategies for preventing and swiftly treating PPH, it remains a common cause of complications and maternal deaths. Earlier work has identified three key barriers to effective treatment of PPH: delayed diagnosis, delayed or inconsistent use of treatments for PPH, and poor uptake of evidence-based guidelines at the hospital level. Management of PPH is time-sensitive; a failure to detect heavy bleeding early or to properly initiate treatment can be deadly.2-4
The E-MOTIVE trial studied the effect of the World Health Organization’s (WHO) first response bundle in preventing severe PPH (> 1 L blood loss) following vaginal birth. E-MOTIVE stands for Early detection and trigger criteria; Massage of uterus; Oxytocic drugs; Tranexamic acid; IV (intravenous) fluids; and Examination and escalation. The “early detection and trigger criteria,” unique to this study, involved a blood-collection drape that included trigger lines at 300 mL and 500 mL. The drape was used in the first hour after birth along with blood pressure and pulse monitoring and documentation of blood loss every 15 minutes. The trigger criteria were based on clinical judgment and blood loss ≥ 500 mL (WHO’s definition of PPH following a vaginal birth) or blood loss ≥ 300 mL plus one abnormal physical exam finding. Importantly, the training and bundle included time parameters within which subsequent steps in the protocol were to be initiated to limit delays in care.
The control hospitals, where usual care was provided, estimated blood loss qualitatively and used assorted interventions for PPH in accordance with local or national guidelines. Importantly, these interventions often were administered sequentially, with uterotonics given as first-line treatment and tranexamic acid reserved for refractory bleeding. Uncalibrated drapes, without alert or action lines, were used in the control hospitals to quantify blood loss for the purpose of the trial.
The study was designed as an international, parallel, cluster-randomized trial. The trial took place between August and October 2021 and included 80 hospitals across Kenya, Nigeria, South Africa, and Tanzania. Hospitals were included for their ability to provide comprehensive obstetrical care (including surgery for PPH), having 1,000 to 5,000 vaginal births per year, and being geographically and administratively distinct from other participating hospitals. Eligible hospitals entered a seven-month baseline control phase where usual care was provided and data were collected prior to being randomly assigned (in a 1:1 ratio) to the usual care group or the trial intervention (the E-MOTIVE group). Usual care was defined as the use of qualitative blood loss assessment and assorted interventions, depending on local or national guidelines. Randomization was at the level of the hospital. Hospitals assigned to the trial intervention underwent a two-month transition phase for training and to allow time for the implementation of the intervention to their practice. Implementation of the intervention was supported by several components: trolleys or carry cases for PPH; simulation-based training; local champions; and evaluation of and feedback to obstetrical providers.
The intervention phase lasted seven months, and mixed-methods process evaluations were conducted to assess the implementation outcomes that occurred in these months. Of the 80 participating hospitals, data were analyzed for 78 hospitals that had a total of 210,132 patients during the trial — 110,437 in the baseline phase and 99,659 in the implementation phase. For comparison between the intervention group and the usual care group, the researchers analyzed clusters in a generalized linear mixed model with a constrained baseline analysis. The study was powered to detect a 25% decrease in relative risk with 90% power.
The primary outcome for the study was a composite of three binary measures: blood loss > 1 L within two hours after birth; postpartum laparotomy for bleeding anytime up to hospital discharge; or maternal death from bleeding anytime up to hospital discharge. The detection of PPH, comparing diagnosis of PPH objectively via calibrated blood-collection drape vs. qualitatively, and adherence to the treatment bundle were measured as secondary implementation outcomes.
In the intervention group, the primary outcome event occurred in 794 of 48,678 patients (1.6%) compared to 2,139 of 50,044 (4.3%) in the usual-care group (risk ratio [RR], 0.40; 95% confidence interval [CI], 0.32 to 0.50; P < 0.001). There were 45 maternal deaths that occurred during the study — 17 deaths in the E-MOTIVE intervention group and 28 deaths in the usual care group (RR, 0.73; 95% CI, 0.40 to 1.31). PPH was the cause of 12 and 18 deaths, respectively. Cases of laparotomy were few, with 12 cases in the E-MOTIVE intervention group and seven cases in the usual care group (RR, 1.72; 95% CI, 0.57 to 5.16). The usual care group detected only 51.1% of postpartum hemorrhage cases, while the E-MOTIVE intervention group detected 93.1% of postpartum hemorrhage cases (rate ratio, 1.58; 95% CI, 1.41 to 1.76). Adherence to the treatment bundle was 91.2% in the intervention group and 19.4% in the usual care practice group (rate ratio, 4.94; 95% CI, 3.88 to 6.28).5
COMMENTARY
The E-MOTIVE study adds to the existing literature on the importance of quantitative assessment of blood loss in the timely detection and management of PPH. Nearly half of cases of PPH were missed when blood loss was evaluated qualitatively, indicating the importance for all obstetricians of changing their practice of assessing blood loss following delivery. Similarly, this study demonstrates the importance of a swift response to abnormal bleeding postpartum, with minimal delay in between interventions, or therapies given in parallel. Following diagnosis of PPH and uterine massage, a bolus of IV oxytocin was injected and a maintenance dose given over a four-hour period. Tranexamic acid (1 g IV) was the next intervention in the pathway, along with IV fluids. A quick transition to escalation then would occur, if bleeding had not resolved. Approximately 60% fewer severe PPH cases occurred with a standardized approach to PPH management (RR, 0.40; 95% CI, 0.32 to 0.50; P < 0.001).
This approach of bundling interventions for PPH also is endorsed by the American College of Obstetricians and Gynecologists and other leading public health authorities. Reducing morbidity and mortality from hemorrhage during childbirth requires labor and delivery departments to adopt a standardized approach to expedite effective care.
REFERENCES
- World Health Organization. Trends in maternal mortality 2000 to 2020: Estimates by WHO, UNICEF, UNFPA, World Bank Group and UNDESA/Population Division. Published Feb. 23, 2023. https://www.who.int/publications/i/item/9789240068759
- Althabe F, Therrien MNS, Pingray V, et al. Postpartum hemorrhage care bundles to improve adherence to guidelines: A WHO technical consultation. Int J Gynaecol Obstet 2020;148:290-299.
- Hancock A, Weeks AD, Lavender DT. Is accurate and reliable blood loss estimation the 'crucial step' in early detection of postpartum haemorrhage: An integrative review of the literature. BMC Pregnancy Childbirth 2015;15:230.
- Widmer M, Piaggio G, Nguyen TMH, et al. Heat-stable carbetocin versus oxytocin to prevent hemorrhage after vaginal birth. N Engl J Med 2018;379:743-752.
- Gallos I, Devall A, Martin J, et al. Randomized trial of early detection and treatment of postpartum hemorrhage. N Engl J Med 2023;389:11-21.
This international, parallel, cluster-randomized trial assigned 80 secondary-level hospitals in four African countries to evaluate a multicomponent intervention for early detection and treatment of postpartum hemorrhage (PPH) vs. usual care following a vaginal birth. The intervention group had 60% less severe PPH cases (> 1 L blood loss) than the usual care cohort.
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