A Phase 2 interventional study of Misoprostol in Postpartum Haemorrhage and Retained Placenta, sponsored by Hawler Medical University. Completed at 1 site in Iraq. Open to female participants aged 15 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-22.
Sponsored by Hawler Medical University · Phase 2, Interventional, and Treatment
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
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
445 studies on the registry are indexed under Postpartum Hemorrhage; 75 are open to participants now.
This study's enrollment of 509 is above the median of 148 across 340 interventional studies indexed under Postpartum Hemorrhage.
Browse Postpartum Hemorrhage studies →Hawler Medical University is the lead sponsor of 56 studies on the registry; 6 are open to participants now.
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Misoprostol 400 micro-gram dissolved in 20 mL normal saline will be injected in the umbilical vein in the first group
Drug: Misoprostol
Misoprostol 800 micro-gram dissolved in 20 mL normal saline will be injected in umbilical cord of the second group
Drug: Misoprostol
2 regimes of misoprostol 400 microgram and 800 microgram injections used for 2 groups of women
Also known as: Cytotic
Delivery of placenta after injection of of 400 Microgram intraumbilical misoprostol versus 800 microgram of misoprostol
complete delivery of placenta after injection of intraumbilical misoprostol
Time frame: up to 30 minutes after intraumbilical injection
The amount of blood loss vaginally in both groups
To estimate the amount of vaginal blood loss from time of injection of the the interventional drug and till the delivery of the placenta
Time frame: up to 30 minutes after injection of placenta
The time of delivery of placenta in both groups
the time interval estimation from the injection to complete delivery of the placenta
Time frame: up to 30 minutes after delivery of the placenta
side effects of misoprostol
Any side effects related to misoprostol after the injection (Fever, severing , diarrhea)
Time frame: up to 24 hours after delivery of placenta
Plan to share: No
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Hawler Medical University