AbstractObjectiveOur objective was to evaluate whether prophylactic administration of intramuscular (IM) methylergonovine after cord clamping reduces blood loss during planned cesarean delivery (CD) of twin pregnancies.MethodThis single‐center randomized placebo‐controlled triple‐blinded trial compared the effects of IM methylergonovine versus saline placebo control on maternal blood loss at CD. Pregnant individuals with twin gestations at ≥ 34 weeks of gestation undergoing planned CD were enrolled. Methylergonovine or saline placebo was administered immediately after umbilical cord clamping of the second twin in addition to standard oxytocin prophylaxis. The primary outcome was a change in mean maternal hemoglobin (Hgb) level from preoperative to postoperative day 1 (POD 1). Secondary outcomes include intraoperative blood loss, additional uterotonic use, and rates of postpartum hemorrhage and transfusion. We planned to enroll 66 patients to detect a standard deviation (SD) greater drop in postoperative maternal Hgb, assuming −1.40 (± 0.83) g/dL Hgb difference after planned CDs (90% power, alpha 0.05). Pearson chi‐square test, Fisher's exact test, t‐test, and Wilcoxon rank sum test with intent‐to‐treat principles were performed as appropriate. A linear regression model was performed on the primary outcome.ResultsA total of 66 patients (33 methylergonovine and 33 placebo) were randomized. There were no demographic differences between methylergonovine and placebo groups. Median gestational age at delivery was 37 weeks for both groups. Mean Hgb drop on POD 1 was 1.1 g/dL (SD 0.7 g/dL) for methylergonovine and 2.1 g/dL (SD 0.9 g/dL) for placebo (p < 0.001). Quantitative blood loss was significantly lower in patients receiving prophylactic methylergonovine (891 vs. 1017 mL, p = 0.003). Postpartum hemorrhage rates were lower in the methylergonovine group (18.2% vs. 54.5%, p = 0.002). There were seven cases of unblinding due to hemorrhage in the placebo group compared to no cases in the methylergonovine group (p = 0.01); all unblinded subjects received methylergonovine.ConclusionProphylactic IM methylergonovine administered after umbilical cord clamping during twin CD significantly reduced intraoperative blood loss and hemoglobin drop on POD 1. These data support further study of methylergonovine as a preventative treatment strategy at the time of twin CD.
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