Sublingual Oxytocin Phase 2 Trial to Evaluate Post-partum Hemorrhage Prevention Efficacy
Background
Post-partum hemorrhage (PPH) remains a leading cause of maternal mortality worldwide, with uterine atony accounting for up to 80% of cases. Current standard-of-care often involves intravenous or intramuscular administration of oxytocin, which requires trained personnel and sterile injection equipment, posing challenges in low-resource settings. An easily administered, non-injectable formulation of oxytocin could significantly improve access to timely PPH prevention, reducing maternal morbidity and mortality by ensuring rapid uterine contraction.
Study Design
This open-label, randomized, single-center, dose-ascending Phase 2 trial (NCT06968481) is designed to evaluate the efficacy and safety of sublingual Oxytocin for preventing PPH. The study plans to enroll an estimated 330 term pregnant women undergoing uncomplicated vaginal delivery. Participants will be randomized to receive either sublingual Oxytocin 1000 IU, 3000 IU, or 6000 IU, or a reference arm of intramuscular Oxytocin 10 IU. The primary endpoint will assess the prevention of PPH caused by uterine atony.
Why It Matters
A successful sublingual Oxytocin formulation could revolutionize PPH prevention, particularly in settings where intravenous access or skilled personnel are limited. This non-injectable route offers a practical, user-friendly alternative to current protocols, potentially enabling broader and more rapid administration immediately post-delivery. Such a development could significantly reduce maternal deaths and complications globally, making PPH prevention more accessible and less reliant on complex medical infrastructure. This trial is a critical step towards validating a simpler, potentially life-saving intervention.
oxytocin
post-partum hemorrhage
uterine atony
maternal health
phase 2 trial
prevention