NCT04044287

Misoprostol in the Prevention of Postpartum Haemorrhage

Sublingual Misoprostol and Routine Third Stage Prophylaxis for the Prevention of Postpartum Haemorrhage: A Randomised Controlled Clinical Trial.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,496 (estimated)
• Sponsor: The University of The West Indies · Academic / Other
• Sex: Female
• Age: 16 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Postpartum haemorrhage is a major contributor to maternal mortality in the developing world. The incidence is between 5 and 12% in Jamaica and varies depending on the route of delivery. Misoprostol is a uterotonic agent which has the potential to augment the effects of the standard parenteral oxytocic agents used as best practice in the active management of the third stage of labour, thereby reducing the risk of postpartum haemorrhage and its attendant complications. The Aim of the study is twofold: to show that this additive effect translates to a reduced postpartum haemorrhage rate and secondly to demonstrate reduced side effects of misoprostol resulting from the lower dose and the powdered sublingual administration.

Conditions

• Postpartum Hemorrhage

Interventions

Type	Name	Description
DRUG	200 micrograms of misoprostol	200 micrograms of powdered misoprostol applied sublingually together with standard parenteral oxytocic therapy
DRUG	Placebo Oral Tablet	200 micrograms of powdered placebo applied sublingually together with standard parenteral oxytocic therapy

Timeline

• Start date: 2013-01-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2019-08-05
• Last updated: 2019-08-05

Locations

1 site across 1 country: Jamaica