NCT02704780

Two Different Regimens of Misoprostol in Retained Placenta

Umbilical Vein Injection of 800µg Misoprostol Versus 400 µg Misoprostol in the Treatment of Retained Placenta: A Multicenter, Randomized Double Blind Controlled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 509 (actual)
• Sponsor: Hawler Medical University · Academic / Other
• Sex: Female
• Age: 15 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study evaluates intra umbilical vein injection of 800 µg versus 400 µg misoprostol for the treatment of retained placenta to reduce the need of manual removal of placenta under general anaesthesia

Detailed description

The third stage of labor may be complicated by retained placenta, which may cause severe bleeding and infection, with a potentially fatal outcome. Manual removal of placenta is the current standard of management of retained placenta which usually requires general or regional anaesthesia at a hospital and it is an invasive procedure that may lead to bleeding, trauma and infection. Intraumbilical injection of uterotonic agent( misoprostol) is an easy, non invasive procedure. A randomized clinical trial are required to determine the difference between two doses of misoprostol 400 versus 800 micro gram for management of retained placenta

Conditions

• Postpartum Haemorrhage
• Retained Placenta

Interventions

Type	Name	Description
DRUG	Misoprostol	2 regimes of misoprostol 400 microgram and 800 microgram injections used for 2 groups of women

Timeline

• Start date: 2016-03-01
• Primary completion: 2019-02-01
• Completion: 2019-02-14
• First posted: 2016-03-10
• Last updated: 2019-02-22

Locations

1 site across 1 country: Iraq