NCT06968481

Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage

A Phase 2, Single-center, Open-label, Randomized, Dose Ascending Trial to Evaluate the Efficacy and Safety of Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage Caused by Uterine Atony in Term Pregnant Women Having an Uncomplicated Vaginal Delivery

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: Insud Pharma · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

An open-label, randomized, single-center, dose ascending trial will be conducted to evaluate the efficacy and safety of sublingual oxytocin for the prevention of post-partum hemorrhage caused by uterine atony in term pregnant women having an uncomplicated vaginal delivery. The primary objective is to estimate the optimal effective dose (ED90) of sublingual oxytocin administered during the active management of the third stage of labor to result in satisfactory uterine tone and a cumulative blood loss \< 500 ml at 20 minutes after vaginal delivery in 90% of parturients with an acceptable safety profile.

Conditions

• Post Partum Hemorrhage

Interventions

Type	Name	Description
DRUG	Oxytocin	Sublingual oxytocin 1000 IU, 3000 IU or 6000 IU
DRUG	Oxytocin	Intramuscular oxytocin 10 IU

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-02-01
• Completion: 2026-04-30
• First posted: 2025-05-13
• Last updated: 2025-05-13

Locations

1 site across 1 country: Nigeria