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Randomized Controlled Trial
. 2012 Feb;119(2 Pt 1):293-300.
doi: 10.1097/AOG.0b013e318242da74.

Higher-dose oxytocin and hemorrhage after vaginal delivery: a randomized controlled trial

Alan T N Tita  1 , Jeff M Szychowski, Dwight J Rouse, Cynthia M Bean, Victoria Chapman, Allison Nothern, Dana Figueroa, Rebecca Quinn, William W Andrews, John C Hauth
Affiliations
Randomized Controlled Trial

Higher-dose oxytocin and hemorrhage after vaginal delivery: a randomized controlled trial

Alan T N Tita et al. Obstet Gynecol. 2012 Feb.

Abstract

Objective: Higher-dose oxytocin is more effective than lower-dose regimens to prevent postpartum hemorrhage after cesarean delivery. We compared two higher-dose regimens (80 units and 40 units) to our routine regimen (10 units) among women who delivered vaginally.

Methods: In a double-masked randomized trial, oxytocin (80 units, 40 units, or 10 units) was administered in 500 mL over 1 hour after placental delivery. The primary outcome was a composite of any treatment of uterine atony or hemorrhage. Prespecified secondary outcomes included outcomes in the primary composite and a decline of 6% or more in hematocrit. A sample size of 600 per group (N=1,800) was planned to compare each of the 80-unit and 40-unit groups to the 10-unit group. At planned interim review (n=1,201), enrollment in the 40-unit group was stopped for futility and enrollment continued in the other groups.

Results: Of 2,869 women, 1,798 were randomized as follows: 658 to 80 units; 481 to 40 units; and 659 to 10 units. Most characteristics were similar across groups. The risk of the primary outcome in the 80-unit group (6%; relative risk [RR] 0.93, 95% confidence interval [CI] 0.62-1.40) or the 40-unit group (6%; RR 0.94, 95% CI 0.61-1.47) was not different compared with the 10-unit group (7%). Treatment with additional oxytocin after the first hour was less frequent with 80 units compared with 10 units (RR 0.41, 95% CI 0.19-0.88), as was a 6% or more decline in hematocrit (RR 0.83, 95% CI 0.69-0.99); both outcomes declined with increasing oxytocin dose. Outcomes were similar between the 40-unit and 10-unit groups.

Conclusion: Compared with 10 units, 80 units or 40 units of prophylactic oxytocin did not reduce overall postpartum hemorrhage treatment when administered in 500 mL over 1 hour for vaginal delivery. Eighty units decreased the need for additional oxytocin and the risk of a decline in hematocrit of 6% or more.

Clinical trial registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00790062.

Level of evidence: I.

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Conflict of interest statement

Financial Disclosure: The authors did not report any potential conflicts of interest.

Figures

Figure 1
Figure 1
Flow of patients through the oxytocin trial
See this image and copyright information in PMC

Comment in

References

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