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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
400
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
20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby
2 ampoules of TA in 100 ml saline by slow infusion
Aswan University
Aswān, Egypt
RECRUITINGThe number of the patient need of additional pharmacological uterotonic.
calculate the number of the patient need of additional pharmacological uterotonic.
Time frame: 24 hours post operative
estimation of intraoperative blood loss (ml)
measure Intraoperative blood loss in ml by gravimetric methods
Time frame: during the operation
amount of postoperative blood loss
measure amount of blood loss post operative in ml by gravimetric methods
Time frame: 24 hours post operative
number of patient with postpartum hemorrhage
calculation of the number of the patients with blood loss \>1000 ml
Time frame: 24 hours post operative
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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
2 placebo ampoules to TA in 100 ml saline by slow infusion
two placebo ampoules to oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby