Randomized Trial Compares Oxytocin 2.5 Units to 10 Units for Uterotonic Efficacy and Safety During C-Section

Postpartum hemorrhage remains a leading cause of maternal mortality globally, necessitating effective uterotonic agents. Oxytocin is the gold standard for preventing and treating uterine atony after delivery, including during caesarean sections. While highly effective, intravenous bolus doses of oxytocin can induce cardiovascular side effects, such as hypotension and ECG changes, particularly with higher doses. The optimal balance between achieving adequate uterine tone and minimizing adverse effects is crucial. This study aimed to investigate if a lower dose of Oxytocin could maintain efficacy while improving safety during C-sections.

This was a randomized, triple-blinded, Phase 4 clinical trial conducted at Mulago Hospital, enrolling 103 patients undergoing caesarean section. Participants were randomized to receive either an intravenous bolus of Oxytocin 2.5 IU or Oxytocin 10 IU. The primary endpoints were change in uterine tone, assessed by the surgeon as adequate or inadequate at 3, 6, and 9 minutes after the initial dose, and time to adequate uterine tone from infant delivery to the completion of the C-section. Secondary outcomes included monitoring for myocardial ischemia, hypotension, and blood loss as safety parameters.

The provided abstract and NCT record do not include specific numerical findings or results from this completed Phase 4 trial. The study was designed to rigorously compare the uterotonic efficacy and safety profiles of two distinct Oxytocin doses. Researchers aimed to determine if 2.5 IU of Oxytocin could achieve uterine tone comparable to the standard 10 IU dose, while simultaneously assessing safety parameters. Primary endpoints included the qualitative assessment of uterine tone (adequate or inadequate, as judged by the surgeon at 3, 6, and 9 minutes post-dose) and the time to adequate uterine tone from infant delivery to the C-section completion. Secondary safety outcomes, as indicated by the NCT record, involved monitoring for myocardial ischemia, hypotension, and blood loss. The trial, which enrolled 103 participants, completed data collection in July 2008, but the specific data points, statistical comparisons, and conclusions regarding the comparative efficacy and safety of the two Oxytocin doses are not detailed in the available information.