Postpartum Hemorrhage Risks Averted With Monitoring, Bundled Treatment

— Trial in low- and middle-income countries shows big advantage for severe maternal outcomes

MedpageToday
A photo of a nurse assisting a woman giving birth in a hospital.

Early detection of hemorrhage after childbirth and initiating all recommended treatment strategies at once, rather than waiting sequentially, reduced severe maternal outcomes, the E-MOTIVE trial showed.

Among more than 200,000 vaginal delivery patients in low- and middle-income countries, the intervention cut the composite risk -- 1,000 mL or more of blood loss, laparotomy for bleeding, or maternal death from bleeding -- by 60% compared with usual care (1.6% vs 4.3%; risk ratio [RR] 0.40, 95% CI 0.32-0.50, P<0.001), reported Adam Devall, BMedSci, PhD, of the WHO Collaborating Centre on Global Women's Health at the University of Birmingham in England, and colleagues.

"This benefit was presumably attributable to observed improvements in the detection of postpartum hemorrhage and the use of the WHO first-response bundle in the hospitals in the intervention group," they wrote in the New England Journal of Medicine.

Secondary bleeding endpoints and transfusions also dropped with randomization to use of a calibrated drape to catch blood for better assessment of volume lost and concurrent use of WHO-recommended interventions (uterine massage, oxytocic drugs, tranexamic acid, IV fluids, and a process for examination and escalation to advanced treatment).

All the interventions can be delivered by midwives.

"This new approach to treating postpartum haemorrhage could radically improve women's chances of surviving childbirth globally, helping them get the treatment they need when they need it," said senior author Arri Coomarasamy, MBChB, MD, also of the University of Birmingham, in a press release from the WHO. "Time is of the essence when responding to postpartum bleeding, so interventions that eliminate delays in diagnosis or treatment should be game-changers for maternal health."

A WHO report released the same day documented declining progress in the "extraordinarily high" number of preventable maternal, perinatal, and neonatal deaths, totalling some 14.5 million a year.

A key part of the problem is intervening early enough for effective response. "Blood loss after birth is currently visually estimated, which results in underestimation of blood loss and delays in the initiation of lifesaving treatment," Devall and team noted. Further time is lost waiting to see if the initial interventions are effective before starting the next.

The trial included 80 hospitals in Kenya, Nigeria, South Africa, and Tanzania cluster randomized from August to October 2021 to continue providing usual care or to implement the trial intervention for 7 months after a 7-month baseline period of usual care for postpartum hemorrhage. A 2-month transition period allowed for training and incorporation of the intervention into practice.

Control hospitals estimated blood loss visually with drapes that didn't have marks to indicate blood loss levels but could be used to measure bleeding for study purposes. Their interventions for postpartum hemorrhage followed local or national guidelines, typically with oxytocic drugs given as first-line treatment and tranexamic acid reserved for refractory bleeding. The difference in use of the treatment bundle showed the expected gap between the intervention group and usual care patients (91.2% vs 19.4%).

Inclusion-eligible hospitals had a case volume of 1,000 to 5,000 vaginal births per year and capacity for comprehensive obstetrical care, including surgery for postpartum hemorrhage. Hospitals that had already implemented a bundle for treatment of postpartum hemorrhage were excluded.

Postpartum hemorrhage, defined by at least 500 mL of blood loss, was detected in more of the intervention group patients compared with the usual care group (93.1% vs 51.1%; RR 1.58, 95% CI 1.41-1.76). Postpartum blood transfusion for bleeding occurred in 1.2% and 1.9%, respectively (RR 0.71, 95% CI 0.55-0.90), "which is of particular importance in low-income countries where blood is a scarce and expensive resource," according to the WHO release.

While the trial was underpowered to look at maternal mortality, Devall and colleagues noted that it trended in favor of the intervention, with 17 cases compared with 28 in the usual-care group (RR 0.73, 95% CI 0.40-1.31).

"The E-MOTIVE protocol allowed for triggering of the treatment bundle at blood loss of 300 mL or more if there was an accompanying abnormality in the vital signs or clinical observations," they wrote. "This trigger criterion was commonly used in the hospitals in the intervention group, and this trigger criterion probably underlies the apparent benefit of the intervention for less-severe postpartum hemorrhage."

Limitations of the trial included a lack of data on some clinical outcomes, like postnatal hemoglobin and anemia, and on patients' experience. Also, conduct of the trial in low- and middle-income countries means that "further implementation research is needed in high-income settings, focusing on process outcomes such as postpartum hemorrhage detection and bundle use to ensure broader generalizability," the researchers pointed out.

Disclosures

The trial was supported by an investment grant from the Bill and Melinda Gates Foundation.

Devall and Coomarasamy disclosed no relevant conflicts of interest.

Primary Source

New England Journal of Medicine

Source Reference: Gallos I, et al "Randomized trial of early detection and treatment of postpartum hemorrhage" N Engl J Med 2023; DOI: 10.1056/NEJMoa2303966.