OBJECTIVES: To compare oxytocin plus ergometrine against oxytocin alone, when administered as part of the active management of the 3rd stage of labor, in terms of postpartum hemorrhage and manual removal of the placenta. DESIGN: A double-blind, randomized controlled trial. SETTING:A university teaching hospital: Hope Hospital, Salford. PATIENTS: All women delivering in the hospital over the period of the trial, except those for whom a cesarean section was planned, or who had significant hypertension or cardiac disease. INTERVENTIONS:Syntometrine (5 units of oxytocin with 0.5 mg of ergometrine) versus 5 units of Syntocinon (oxytocin), both given by intramuscular injection with delivery of the anterior shoulder. MAIN OUTCOME MEASURES: Postpartum blood loss, the length of the 3rd stage of labor, and the need for manual removal of the placenta. RESULTS:Four hundred sixty-one women were recruited, 230 allocated toergometrine plus oxytocin and 231 to oxytocin alone. The duration of the 3rd stage of labor in each group was similar (difference in means 0.2 mins; 95% confidence interval [CI], -1.0 to 1.5) and the need for manual removal of the placenta (odds ratio [OR] 1.21; 95% CI, 0.37 to 4.00). There was less postpartum blood loss in the oxytocin plus ergometrine group, reflected in the lower incidence of primary postpartum hemorrhage (> 500 mL) (OR 0.37; 95% CI, 0.16 to 0.85). CONCLUSIONS: Judged on the basis of this trial alone, oxytocin plus ergometrine is more effective than oxytocin alone in the prevention of postpartum hemorrhage. However, evidence from other trials shows that the ergometrine component not uncommonly has side effects of nausea, vomiting, and raised blood pressure. The implications for practice therefore depend on the relative weights placed on these competing risks by women and clinicians. Further research is needed to quantify these along with research into possible differential effects on longer-term outcomes and into the implications of a higher dose of oxytocin.
RCT Entities:
OBJECTIVES: To compare oxytocin plus ergometrine against oxytocin alone, when administered as part of the active management of the 3rd stage of labor, in terms of postpartum hemorrhage and manual removal of the placenta. DESIGN: A double-blind, randomized controlled trial. SETTING: A university teaching hospital: Hope Hospital, Salford. PATIENTS: All women delivering in the hospital over the period of the trial, except those for whom a cesarean section was planned, or who had significant hypertension or cardiac disease. INTERVENTIONS:Syntometrine (5 units of oxytocin with 0.5 mg of ergometrine) versus 5 units of Syntocinon (oxytocin), both given by intramuscular injection with delivery of the anterior shoulder. MAIN OUTCOME MEASURES: Postpartum blood loss, the length of the 3rd stage of labor, and the need for manual removal of the placenta. RESULTS: Four hundred sixty-one women were recruited, 230 allocated to ergometrine plus oxytocin and 231 to oxytocin alone. The duration of the 3rd stage of labor in each group was similar (difference in means 0.2 mins; 95% confidence interval [CI], -1.0 to 1.5) and the need for manual removal of the placenta (odds ratio [OR] 1.21; 95% CI, 0.37 to 4.00). There was less postpartum blood loss in the oxytocin plus ergometrine group, reflected in the lower incidence of primary postpartum hemorrhage (> 500 mL) (OR 0.37; 95% CI, 0.16 to 0.85). CONCLUSIONS: Judged on the basis of this trial alone, oxytocin plus ergometrine is more effective than oxytocin alone in the prevention of postpartum hemorrhage. However, evidence from other trials shows that the ergometrine component not uncommonly has side effects of nausea, vomiting, and raised blood pressure. The implications for practice therefore depend on the relative weights placed on these competing risks by women and clinicians. Further research is needed to quantify these along with research into possible differential effects on longer-term outcomes and into the implications of a higher dose of oxytocin.
Authors: Ioannis D Gallos; Helen M Williams; Malcolm J Price; Abi Merriel; Harold Gee; David Lissauer; Vidhya Moorthy; Aurelio Tobias; Jonathan J Deeks; Mariana Widmer; Özge Tunçalp; Ahmet Metin Gülmezoglu; G Justus Hofmeyr; Arri Coomarasamy Journal: Cochrane Database Syst Rev Date: 2018-04-25