The LENTE Study:The Effectiveness of Prophylactic Intramuscular Oxytocin in the Third Stage of Labor Among Low-Risk Women in Primary Care Midwifery Practice: A Randomized Controlled Trial

PURPOSE: To test third stage management of labor for low-risk women comparing routine prophylactic intramuscular oxytocin management versus modified expectant management. STUDY DESIGN: Randomized controlled multicenter trial in primary care midwifery practice. MAJOR FINDINGS: 32.4% of women in the prophylactic intramuscular oxytocin management group had blood loss of 500 mL or more versus 44.2% in the modified expectant management group, relative risk (RR) 0.61, 95% confidence interval (CI) [0.50, 0.74]. The percentage of women experiencing postpartum hemorrhage (PPH) defined as more than 1,000 mL blood loss was 6.3% in the prophylactic intramuscular oxytocin management group versus 11.9% in the modified expectant management group (RR 0.50, 95% CI [0.36, 0.71]). The type of management showed no significant differences between the two groups in clinically relevant indicators of women's short-term health such as the number of referrals, treatment given, hemoglobin level 36 hours postpartum, and breastfeeding rates after 1 week. Medium-term health such as hemoglobin level at 6 weeks postpartum, women's perceptions of tiredness, and breastfeeding rates at 3 months after birth also showed no differences between the two groups. CONCLUSION: Third stage management by means of routine prophylactic intramuscular oxytocin reduced the risk of postpartum hemorrhage in a group of childbearing women at low risk of complications in primary midwifery care compared to modified expectant third stage management, but there was no evidence this was associated with a reduction in clinically relevant adverse health outcomes