Abstract
BackgroundOxytocin for postpartum hemorrhage (PPH) prophylaxis is commonly administered by either intramuscular (IM) injection or intravenous (IV) infusion with both routes recommended equally and little discussion of potential differences between the two. This trial assesses the effectiveness and safety of 10 IU oxytocin administered as IM injection versus IV infusion and IV bolus during the third stage of labor for PPH prophylaxis.MethodsIn two tertiary level Egyptian maternity hospitals, women delivering vaginally without exposure to pre-delivery uterotonics were randomized to one of three prophylactic oxytocin administration groups after delivery of the baby. Blood loss was measured 1 h after delivery, and side effects were recorded. Primary outcomes were mean postpartum blood loss and proportion of women with postpartum blood loss ≥500 ml in this open-label, three-arm, parallel, randomized controlled trial.ResultsFour thousand nine hundred thirteen eligible, consenting women were randomized. Compared to IM injection, mean blood loss was 5.9% less in the IV infusion arm (95% CI: -8.5, − 3.3) and 11.1% less in the IV bolus arm (95% CI: -14.7, − 7.8). Risk of postpartum blood loss ≥500 ml in the IV infusion arm was significantly less compared to IM injection (0.8% vs. 1.5%, RR = 0.50, 95% CI: 0.27, 0.91). No side effects were reported in any arm.ConclusionsIntravenous oxytocin is more effective than intramuscular injection for the prevention of PPH in the third stage of labor. Oxytocin delivered by IV bolus presents no safety concerns after vaginal delivery and should be considered a safe option for PPH prophylaxis.Trial registrationclinicaltrials.gov #NCT01914419, posted August 2, 2013.
Highlights
Oxytocin for postpartum hemorrhage (PPH) prophylaxis is commonly administered by either intramuscular (IM) injection or intravenous (IV) infusion with both routes recommended and little discussion of potential differences between the two
The risk of having postpartum blood loss ≥500 ml among women receiving oxytocin via IV infusion was significantly reduced compared to women receiving IM injection oxytocin (0.8% vs. 1.5%, relative risks (RRs) = 0.50, 95% confidence intervals (CIs): 0.27, 0.91)
No statistically significant differences were seen in proportion of hypotension across groups 1 h after delivery (IM injection, IV infusion and IV bolus). The findings of this large randomized controlled trial exploring difference in route of prophylactic oxytocin administration in the third stage of labor suggest that route of oxytocin administration affects postpartum blood loss. These results substantiate earlier findings [12, 13, 24] that both IV infusion and IV bolus administration of 10 IU of oxytocin were associated with significantly less average postpartum blood loss when compared to IM injection
Summary
Oxytocin for postpartum hemorrhage (PPH) prophylaxis is commonly administered by either intramuscular (IM) injection or intravenous (IV) infusion with both routes recommended and little discussion of potential differences between the two. This trial assesses the effectiveness and safety of 10 IU oxytocin administered as IM injection versus IV infusion and IV bolus during the third stage of labor for PPH prophylaxis. Despite many discussions of the clinical importance of route [9, 15,16,17,18,19,20,21,22,23,24,25], differences in efficacy remain largely uninvestigated. The few published studies investigating route are inconsistent, with two showing reduced blood loss associated with IV administration [24, 25] and two others showing no difference between IV and IM administration [20, 21]
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