Inhaled Oxytocin's Safety, Tolerability, and Drug Levels Compared to IM/IV for Post-Partum Hemorrhage

Post-partum hemorrhage (PPH) remains a leading cause of maternal morbidity and mortality globally, particularly in resource-poor settings. Current standard-of-care involves injectable oxytocin, typically administered intramuscularly (IM) or intravenously (IV). However, these routes require sterile needles, trained personnel, and cold chain storage, posing significant logistical challenges in low-resource environments. An easily administered, stable formulation of oxytocin, such as a dry powder for inhalation, could overcome these barriers, improving access to life-saving treatment and reducing the global burden of PPH. This study explores the potential of inhaled oxytocin to address these critical gaps in maternal healthcare by evaluating its safety, tolerability, and drug levels.

This study is designed to evaluate a stable, dry-powder formulation of inhaled oxytocin (IH) against standard administration routes. Two distinct groups of women are being enrolled. Group 1 comprises pregnant women (34-41 weeks gestation) who will be randomized to receive either IH oxytocin or 10 IU intramuscular (IM) oxytocin during the third stage of labor for active management. Group 2 includes healthy non-pregnant women of childbearing potential, who will receive IH oxytocin and intravenous (IV) oxytocin in a crossover design across two dosing sessions. The primary objectives are to assess the safety and tolerability of IH oxytocin and to characterize its drug levels (pharmacokinetics) compared to IM and IV routes using methods like plasma concentration analysis.