Life-Saving Solution for Postpartum Hemorrhage

A life-saving solution dramatically reduces severe bleeding after childbirth, addressing a critical complication of postpartum hemorrhage. This intervention has the potential to improve maternal outcomes and reduce maternal mortality rates.

December 2023
Life-Saving Solution for Postpartum Hemorrhage

A trial of a set of interventions to control postpartum hemorrhage, published in the New England Journal of Medicine , found a 60% reduction in heavy bleeding.

Summary

Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage

Background

Delays in detecting or treating postpartum hemorrhage can lead to complications or death. A blood collection drape can help provide an objective, accurate, and early diagnosis of postpartum hemorrhage, and late or inconsistent use of effective interventions can be addressed through a treatment package.

Methods

We conducted an international cluster-randomized trial to evaluate a multicomponent clinical intervention for postpartum hemorrhage in patients delivering vaginally. The intervention included a calibrated blood collection field for early detection of postpartum hemorrhage and a first-response treatment package ( uterine massage, oxytocic medications, tranexamic acid, intravenous fluids, screening and escalation ), supported by an implementation strategy ( intervention group).

Hospitals in the control group provided usual care. The primary outcome was a composite of severe postpartum hemorrhage (blood loss, ≥1000 mL), laparotomy for hemorrhage, or maternal death due to hemorrhage. Key secondary outcomes of implementation were detection of postpartum hemorrhage and adherence to the treatment package.

Results

A total of 80 secondary level hospitals in Kenya, Nigeria, South Africa and Tanzania, in which 210,132 patients underwent vaginal delivery, were randomly assigned to the intervention group or the usual care group.

Among hospitals and patients with data, a primary outcome event occurred in 1.6% of patients in the intervention group, compared with 4.3% of those in the usual care group (hazard ratio, 0.40; 95% confidence interval [CI], 0.32 to 0.50; P<0.001).

Postpartum hemorrhage was detected in 93.1% of patients in the intervention group and 51.1% of those in the usual care group (rate ratio, 1.58; 95% CI, 1.41 to 1 .76), and the treatment package was used in 91.2% and 19.4%, respectively (rate ratio, 4.94; 95% CI, 3.88 to 6.28).

Conclusions

Early detection of postpartum hemorrhage and use of a treatment package led to a lower risk of the primary outcome, a composite of severe postpartum hemorrhage, laparotomy for bleeding, or death due to bleeding, than usual care among patients who delivered vaginally. .

(Funded by the Bill & Melinda Gates Foundation; E-MOTIVE ClinicalTrials.gov number, NCT04341662. opens in new tab.)

Life-Saving Solution for Postpartum Hemorrhage

E-MOTIVE treatment package . Early detection and treatment of postpartum hemorrhage (PPH) involved the use of a blood collection cloth and the World Health Organization first response treatment package, which together comprise the E-MOTIVE protocol. Misoprostol can be administered rectally or sublingually. IV denotes intravenous. 

Discussion

The E-MOTIVE intervention resulted in a 60% lower risk of the primary outcome (a composite of severe postpartum hemorrhage, laparotomy for postpartum hemorrhage, or maternal death for postpartum hemorrhage) after vaginal delivery in secondary level hospitals in Kenya, Nigeria, South Africa and Tanzania. This benefit was presumably due to the improvements observed in the detection of postpartum haemorrhage and the use of the WHO first response package in the hospitals in the intervention group.

Findings related to postpartum hemorrhage (blood loss, ≥500 mL) were consistent with those of the primary outcome. The E-MOTIVE protocol allowed the treatment package to be activated with a blood loss of 300 ml or more if there was an accompanying abnormality in vital signs or clinical observations. This trigger criterion was frequently used in hospitals in the intervention group, and this trigger criterion likely underlies the apparent benefit of the intervention for less severe postpartum hemorrhage.

We minimized identification and recruitment bias by using broad inclusion criteria to include all patients with vaginal deliveries at the trial hospitals. The analysis approach adjusted for slight residual imbalance in the baseline phase between trial groups in proportion to the primary outcome. We took care, to the extent possible, to avoid contamination between trial groups by ensuring that trial hospitals were geographically dispersed and in different administrative areas. Hospitals in the usual care group continued to provide usual care and had the same access to package components and proven quality medications as those in the intervention group.

Several limitations of this trial deserve consideration. First, due to the pragmatic design, we did not collect information on some clinical outcomes, such as postnatal hemoglobin level and anemia, or on patients’ experience of care. Second, our trial was not powered to assess maternal death, but the findings for this outcome, although rare, were in the same direction as those for the primary outcome. Third, the trial was conducted in low- and middle-income countries; More implementation research is needed in high-income settings, focusing on process outcomes such as postpartum hemorrhage screening and bundle use to ensure broader generalization. Finally, the uncalibrated drapes used at the control hospitals for the purpose of collecting trial outcome data were transparent and therefore providers would have been able to see blood pooling on the drape. To the extent that this situation may have influenced their actions, it would be expected to attenuate the observed effect of the intervention.

Currently, blood loss after birth is estimated visually , resulting in an underestimation of blood loss and delays in starting life-saving treatment. A Cochrane review showed that use of a calibrated drape improved detection of postpartum blood loss compared with visual estimation (rate ratio, 1.86; 95% CI, 1.11 to 3.11 [high certainty ]), but had no clear effect on health outcomes.

This large international trial showed that the use of a calibrated postpartum hemorrhage screening drape and treatment package, supported by a multifaceted implementation strategy, resulted in a substantially lower risk of the primary outcome, a composite of severe postpartum hemorrhage, laparotomy. from bleeding or death from bleeding than usual care.

Comments

A new solution, known as E-MOTIVE , could provide a breakthrough in reducing deaths from childbirth-related bleeding, according to a landmark study published today by researchers at the World Health Organization (WHO) and the University of Birmingham.

Postpartum hemorrhage (PPH), defined as loss of more than 500 ml of blood within 24 hours of birth, is the leading cause of maternal mortality worldwide. It affects approximately 14 million women each year and causes around 70,000 deaths, mainly in low- and middle-income countries, equivalent to 1 death every 6 minutes.

“Postpartum hemorrhage is terrifying, not always predictable, but absolutely treatable. However, its impacts around the world are tragic,” said Dr Pascale Allotey, Director of Sexual and Reproductive Health and Research at WHO and head of the Special Program for Research, Development and Training in Human Reproduction Research (HRP). of the United Nations. “No woman should fear for her life when giving birth. “Effective solutions to address postpartum bleeding must be available and accessible so that all women can experience a safe birth and healthy future with their families.”

The study, which involved more than 200,000 women in four countries, found that objectively measuring blood loss using a simple, low-cost collection device called a "drape" and grouping treatments recommended by the WHO, instead Offering them sequentially resulted in dramatic improvements in outcomes for women. Severe bleeding, when a woman loses more than a liter of blood after giving birth, was reduced by 60% and she was less likely to die.

There was also a substantial reduction in the rate of blood transfusions for bleeding, which is of particular importance in low-income countries where blood is a scarce and expensive resource.

"This new approach to treating postpartum haemorrhage could radically improve women’s chances of surviving childbirth around the world, helping them receive the treatment they need when they need it," said Professor Arri Coomarasamy, who led the trial. and is co-director of the WHO Collaborating Center. Center on Global Women’s Health at the University of Birmingham. “Time is of the essence when responding to postpartum bleeding, so interventions that eliminate delays in diagnosis or treatment should be a game-changer for maternal health.”

Currently, a major challenge in responding to PPH is that it is often detected too late to respond effectively. Most providers use visual inspection to assess bleeding, which tends to underestimate blood loss and can lead to life-threatening delays in treatment. When treatment is provided, it is usually done sequentially with intervals between each intervention, which costs more time if the first options are not effective.

The recommended E-MOTIVE package includes early and accurate detection of PPH using a blood collection cloth. This is complemented by an immediate treatment package where indicated, including uterine massage, medications to contract the uterus and stop bleeding, intravenous fluid administration, an examination and, when necessary, escalation to advanced care. In the trial, the E-MOTIVE intervention was supported with an implementation strategy that consisted of specific training, PPH carts or briefcases, participation of local champions, audits and feedback. All components of the E-MOTIVE intervention can be delivered by midwives.

This research responds to one of the main research priorities identified by more than 130 experts from more than 50 countries at the first Global Summit on PPH convened by WHO and HRP in March this year. The Summit marked the beginning of a collaborative global initiative that aims to substantially reduce the burden of PPH and its consequences in low- and middle-income countries.