XXXX at Cesarean delivery for @entity1167 : a sequential allocation trial to determine the effective dose.

@entity1 @entity16550 @entity398 @entity943 @entity190 @entity591 @entity1316 @entity1167 @entity551
PURPOSE: The aim of this study was to estimate the effective dose 90% (ED90) of @entity16550 to provide adequate uterine tone at Cesarean delivery (CD) for @entity1167 . METHODS: We conducted a double-blind dose-finding study of @entity16550 using a biased-coin up-and-down design in @entity1 undergoing CD for @entity1167 under epidural anesthesia. Forty healthy term pregnant @entity1 who had received at least three hours of @entity398 infusion during labour were recruited for the study. @entity16550 was administered intravenously upon delivery of the anterior shoulder of the fetus. The first @entity1 received 20    g, and the dose for the subsequent @entity1 was determined according to the response of the previous @entity1 as per the biased-coin allocation scheme using increments or decrements of 20    g (maximum 140    g). Uterine tone was assessed by the obstetrician and rated as satisfactory or unsatisfactory throughout the intraoperative period. The primary outcome was satisfactory uterine tone with no need for additional uterotonic drugs intraoperatively. Secondary outcomes included use of additional uterotonic drugs postoperatively in the first 24  hr, estimated @entity190 , and adverse effects. RESULTS: The ED90 of @entity16550 to produce adequate uterine tone was estimated at 121    g (95% confidence interval [CI]: 111 to 130; 99% CI: 108 to 133) using the truncated @entity1316 ( @entity1316 ) method. The isotonic estimator of ED90 was 140    g; however, the observed response rate across all doses was  <  90%. Also, the 95% CI of the @entity1316 estimator is likely to have lower than expected coverage, while the 99% CI may have about 90% coverage. Therefore, these results should be interpreted with caution. The overall median (range) estimated @entity190 was 1,014 (104-2,436)  mL. The overall incidence of @entity551 and @entity591 were 45% and 57.5%, respectively. At a dose of 140    g, the incidence of @entity591 and intraoperative @entity943 was 76% and 14%, respectively. CONCLUSION: The ED90 of @entity16550 at CD for @entity1167 , as determined in our study, should be interpreted with caution since it may be underestimated. This dose is higher than the currently recommended dose of 100    g at elective CD and should not be used routinely given the uncertainty regarding its efficacy and the high incidence of @entity943 at higher doses. This trial was registered at ClinicalTrials.gov, number: NCT01725243.
