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NOT YET RECRUITING
NCT06968481
PHASE2

Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage

Sponsor: Insud Pharma

View on ClinicalTrials.gov

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.

Official title: Phase 2, 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 With Uncomplicated Vaginal Delivery

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

330

Start Date

2026-05-30

Completion Date

2026-10-30

Last Updated

2026-04-23

Healthy Volunteers

No

Interventions

DRUG

Oxytocin sublingual

Sublingual oxytocin 1000 IU, 3000 IU or 6000 IU

DRUG

Oxytocin IM

Intramuscular oxytocin 10 IU

Locations (1)

Africa Center of Excellence for Population Health and Policy

Kano, Nigeria