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Oxytocin Alone Prevents Postpartum Hemorrhage

Jennifer Garcia March 06, 2012 March 6, 2012 Controlled cord traction can be omitted from the management of the third stage of labor without a significant increase in the risk for severe hemorrhage, according to a study published online March 6 in the Lancet. In a noninferiority, randomized controlled trial designed to assess severity of postpartum blood loss, women were assigned to either simplified placental delivery involving gravity and maternal effort (simplified package) or the full package, with controlled cord traction and cord clamping (full package). Women in both groups received oxytocin (10 IU) immediately after birth; uterine massage was administered according to hospital policy. The noninferiority margin for the risk ratio was 1.3, and was chosen by examining the effect of active vs expectant management in previous trials. The primary outcome of blood loss of 1000 mL or more had a risk ratio of 1.09 (95% confidence interval [CI], 0.91 - 1.31). However, the upper 95% CI limit crossed the prestated noninferiority margin, which means the trial failed to demonstrate noninferiority. "We draw two inferences from these results: first, controlled cord traction is safe and its use can be continued in settings in which it is routinely practised; and second, the main component of active management is the uterotonic and in settings in which the full package cannot be used safely, focus should be on the uterotonic component," write A. Metin Glmezoglu, MD, from the Department of Obstetrics and Gynecology, Faculty of Medicine, Khon Kaen University, Thailand, and colleagues. Current (2007) World Health Organization recommendations include administration of oxytocin soon after delivery of the baby, controlled cord traction, and delayed clamping and cutting of the cord until the healthcare worker is ready to apply traction. A press release issued by the Lancet notes the World Health Organization Recommendations for Prevention and Management of Postpartum Hemorrhage guidelines will be revised next week in light of these new findings. Almost a third of pregnancy-related deaths in Africa and Asia are a result of postpartum hemorrhage. The contribution of controlled cord traction on decreasing blood loss has been largely unknown, however, and often requires the presence of trained birth attendants.

Therefore, between June 1, 2009, and October 30, 2010, women who were expected to deliver vaginally were enrolled in the trial from 16 hospitals and 2 primary healthcare centers in Argentina, Egypt, India, Kenya, the Philippines, South Africa, Thailand, and Uganda. Overall, 12,227 women were randomly assigned to the expectant management group and 12,163 to the active management group. Women were excluded if they were first seen in advanced labor, were not able to give consent because of an obstetric emergency, had a mental disorder, or planned to have caesarean delivery. Minors without a guardian or women with twin pregnancies were also excluded. The primary (noninferiority) outcome was severe postpartum hemorrhage, defined as blood loss of 1000 mL or more at 1 hour and up to 2 hours for women who continued to bleed. The secondary (superiority) outcomes were blood transfusion, use of additional uterotonics, blood loss of 500 mL or more, maternal death, manual placental removal, surgical procedures (hysterectomy, ligation of vessels), the composite outcome of maternal death or severe morbidity (admission to intensive care unit, hysterectomy, blood loss of 2000 mL or more, uterine inversion), and initiation of breast-feeding. The researchers note that although the trial failed to demonstrate noninferiority, their findings suggest that injection of oxytocin after delivery is the essential component of delivery management, with or without cord traction. They estimate that out of 581 women, 1 additional woman would have severe hemorrhage if the simplified package were used compared with the full package. The risk for the secondary outcome of postpartum hemorrhage was higher in women given the simplified package than in those given the full package (risk ratio, 1.07; 95% CI, 1.00 - 1.14, superiority hypothesis). The rate of manual placental removal was significantly higher in the simplified package group, however; the researchers felt this was likely because of the high use of ergometrine as prophylaxis in one of the sites in the Philippines. Mean blood loss was approximately 11 mL greater, with the third stage lasting about 7 minutes longer in those women receiving expectant management only. "Our study provides the largest evidence so far of the effect of controlled cord traction as part of active management. Controlled cord traction adds only marginally to the beneficial effect of the full package. Because the main component of the management package is oxytocin, in settings in which no skilled birth attendants are present to give the full package, efforts should focus on the uterotonic (primarily oxytocin) to reduce post-partum haemorrhage," conclude Dr. Glmezoglu and colleagues. In an accompanying commentary, Yap-Seng Chong, MD, from the Department of Obstetrics and Gynecology, National University of Singapore, and Sabaratnam Arulkumaran, MD, from the Division of Obstetrics and Gynecology, St George's Hospital Medical School, London, United Kingdom, discuss how the outcome of this study may lead to better healthcare for women in low-resource settings and result in safer childbirth practices. "By showing that controlled cord traction can be omitted and that the administration of a uterotonic agent is the key intervention that will prevent excessive bleeding after childbirth,

Glmezoglu and co-workers have made it easier for health authorities with scarce resources to provide meaningful assistance to women in rural areas with few or no childbirth facilities," write the commentators. Funding for the study was provided by the US Agency for International Development and UN Development Programme/UN Population Fund/World Health Organization/World Bank Special Programme of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research. The authors and commentators have disclosed no relevant financial relationships. Lancet. Published online March 6, 2012. Commentary

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