NCT03870503

Carbetocin Versus Oxytocin Plus Sublingual Misoprostol in the Management of Atonic Postpartum Hemorrhage

Carbetocin Versus Oxytocin Plus Sublingual Misoprostol in the Management of Atonic Post-partum Hemorrhage (PPH) After Vaginal Delivery: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Aswan University Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to compare the effectiveness and safety of carbetocin vs. oxytocin plus sublingual misoprostol in the management of atonic postpartum hemorrhage (PPH)after vaginal delivery.

Detailed description

The first cause of hemorrhage at the time of delivery is uterine atony; therefore, there is general agreement that active management of the third stage of labor is recommended. Oxytocin is the most widely used uterotonic agent but has a half-life of only 4-10 min, that is why it is better administered as a continuous intravenous infusion to achieve sustained uterotonic activity. Carbetocin is a synthetic long-acting oxytocin agonistic analog with prolonged half-life prolonging its pharmacological effects. Its prolonged uterine activity may theoretically offer advantages over oxytocin in the management of the third stage of labor. The side-effect profile of carbetocin was not found to be different from that of Oxytocin but may prove to be advantageous when compared to Syntometrine.

Conditions

• Postpartum Hemorrhage

Interventions

Type	Name	Description
DRUG	oxytocin	The patient will be received oxytocin 20 IU by intravenous infusion
DRUG	oxytocin plus misoprostol	The patient will be received oxytocin 20 IU by intravenous infusion plus 400 mic gm sublingual misoprostol
DRUG	Carbetocin	The patient received Carbetocin 100 mic gm

Timeline

• Start date: 2019-04-01
• Primary completion: 2021-06-30
• Completion: 2021-08-01
• First posted: 2019-03-12
• Last updated: 2021-09-29

Locations

1 site across 1 country: Egypt