Clinical Trial: Two Different Regimens of Misoprostol in Retained Placenta

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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 Summary: 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
Sponsor: Hawler Medical University

Current Primary Outcome: Delivery of placenta after injection of of 400 Microgram intraumbilical misoprostol versus 800 microgram of misoprostol [ Time Frame: up to 30 minutes after intraumbilical injection ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The amount of blood loss vaginally in both groups [ Time Frame: up to 30 minutes after injection of placenta ]
  • The time of delivery of placenta in both groups [ Time Frame: up to 30 minutes after delivery of the placenta ]
  • side effects of misoprostol (fever,shivering, diarrhea) [ Time Frame: up to 24 hours after delivery of placenta ]


Original Secondary Outcome: Same as current

Information By: Hawler Medical University

Dates:
Date Received: February 19, 2016
Date Started: March 2016
Date Completion: May 2018
Last Updated: June 9, 2016
Last Verified: June 2016