NCT03777878

Carbetocin Versus Oxytocin Infusion Plus Tranexamic Acid During Cesarean Section

Carbetocin Versus Oxytocin Infusion Plus Tranexamic Acid for Prevention of Postpartum Hemorrhage at Cesarean Section: A Double-Blind Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Aswan University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Purpose to evaluates the effects of oxytocin infusion with or without intravenous tranexamic acid (TA) in comparison with Carbetocin for prevention of postpartum hemorrhage at a cesarean section with one or more risk factor for postpartum hemorrhage.

Detailed description

Postpartum hemorrhage (PPH) is potentially life-threatening and is a significant contributor to maternal mortality and morbidity especially in developing countries. The risk of PPH is much higher for women undergoing cesarean delivery (CD). Oxytocin is regarded as the gold standard uterotonic agent but only has a half-life of 4-10 min; therefore, at cesarean section oxytocin must be administered as a continuous intravenous infusion to attain sustained uterotonic activity throughout the surgical procedure and immediate postpartum period. Carbetocin is a long-acting synthetic analog of oxytocin that can be administered as a single-dose injection; intravenously administered carbetocin has a half-life of approximately 40 min. A single intravenous bolus of carbetocin produces a tetanic uterine contraction within 2 min and persists for an average of 60 min following injection. The aim of this study is to compare the effectiveness of combined tranexamic acid (TA) and oxytocin infusion with intravenous carbetocin for prevention of PPH in patients with risk factors during cesarean section.

Conditions

• Cesarean Section Complications

Interventions

Type	Name	Description
DRUG	Carbetocin	100 μg carbetocin ampoule will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby
DRUG	oxytocin	20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby
DRUG	TA	2 ampoules of TA in 100 ml saline by slow infusion
DRUG	placebo to carbetocin	placebo ampoule to carbetocin will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby
DRUG	placebo to TA	2 placebo ampoules to TA in 100 ml saline by slow infusion
DRUG	placebo to oxytocin	two placebo ampoules to oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby

Timeline

• Start date: 2019-01-01
• Primary completion: 2021-03-30
• Completion: 2021-05-01
• First posted: 2018-12-17
• Last updated: 2019-02-15

Locations

1 site across 1 country: Egypt