OBJECTIVE: To evaluate whether sustained transabdominal uterine massage can reduce blood loss after vaginal delivery.
METHODS: In this multicenter randomized controlled trial, eligible women who had delivered vaginally were randomly assigned to receive 10 units oxytocin intramuscularly immediately after delivery of the shoulder plus 30 minutes of sustained transabdominal uterine massage after delivery of the placenta or to 10 units oxytocin intramuscularly alone. The primary outcome was blood loss of 400 mL or more in the 2 hours after delivery of the neonate. Secondary outcomes included blood loss of 1,000 mL or more, blood loss in the 2 hours after delivery, use of therapeutic uterotonics or other hemostatic procedures, hemoglobin of lower than 80 g/L before discharge, and need for blood transfusion. Analysis was by intent to treat. With a one-sided α of 0.05 and a power of 0.8, a sample size of 1,061 women per group was calculated to detect a 3% absolute decrease in the primary outcome.
RESULTS: Of 2,340 eligible women, 1,170 were randomized to oxytocin plus uterine massage and 1,170 to the oxytocin-only group. Baseline characteristics were similar in both groups. The incidence of blood loss of 400 mL or more in the 2 hours after delivery was not significantly different between the two groups (143/1,170 [12.2%] compared with 144/1,170 [12.3%]; relative risk 0.99, 95% confidence interval 0.88–1.13) according to intent-to-treat analysis with a power of more than 0.8. No significant differences were found in the secondary outcomes.
CONCLUSION: In patients delivered vaginally, transabdominal uterine massage after delivery of the placenta in addition to oxytocin does not reduce blood loss when compared with administration of oxytocin alone.
CLINICAL TRIAL REGISTRATION: Chinese Clinical Trial Registry, www.chictr.org, ChiCTR-TRC-11001763.
LEVEL OF EVIDENCE: I