Carbetocin Versus Oxytocin Infusion Plus Tranexamic Acid During Cesarean Section
- Conditions
- Cesarean Section Complications
- Interventions
- Registration Number
- NCT03777878
- Lead Sponsor
- Aswan University Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 400
- Women who undergo elective cesarean section with one or more risk factors for PPH were the candidates for participation
- With fetal macrosomia, polyhydramnios, low insertion of the placenta, multiple gestations, prolonged labor, chorioamnionitis, past history of PPH, diabetes and high parity (5 previous deliveries).
- suspected coagulopathy,
- history of coronary artery disease or hypertension,
- women with a history of hypersensitivity to carbetocin, TA or oxytocin
- general anesthesia, and
- PPH due to causes other than uterine atony.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Carbetocin plus placebo to TA and placebo to oxytocin placebo to TA 100 μg carbetocin ampoule or separate placebo ampoule was diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby plus two placebo ampoules to oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby plus 2 placebo ampoules to TA in 100 ml saline by slow infusion Carbetocin plus placebo to TA and placebo to oxytocin placebo to oxytocin 100 μg carbetocin ampoule or separate placebo ampoule was diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby plus two placebo ampoules to oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby plus 2 placebo ampoules to TA in 100 ml saline by slow infusion oxytocin plus TA placebo to carbetocin 20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby plus 1gm TA in 100ml saline by slow infusion plus 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 oxytocin plus placebo to TA and placebo to carbetocin placebo to TA 20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby plus 2 placebo ampoules to TA in 100 ml saline by slow infusion plus 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 oxytocin plus placebo to TA and placebo to carbetocin placebo to carbetocin 20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby plus 2 placebo ampoules to TA in 100 ml saline by slow infusion plus 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 Carbetocin plus placebo to TA and placebo to oxytocin Carbetocin 100 μg carbetocin ampoule or separate placebo ampoule was diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby plus two placebo ampoules to oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby plus 2 placebo ampoules to TA in 100 ml saline by slow infusion oxytocin plus TA oxytocin 20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby plus 1gm TA in 100ml saline by slow infusion plus 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 oxytocin plus placebo to TA and placebo to carbetocin oxytocin 20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby plus 2 placebo ampoules to TA in 100 ml saline by slow infusion plus 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 oxytocin plus TA TA 20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby plus 1gm TA in 100ml saline by slow infusion plus 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
- Primary Outcome Measures
Name Time Method The number of the patient need of additional pharmacological uterotonic. 24 hours post operative calculate the number of the patient need of additional pharmacological uterotonic.
- Secondary Outcome Measures
Name Time Method estimation of intraoperative blood loss (ml) during the operation measure Intraoperative blood loss in ml by gravimetric methods
number of patient with postpartum hemorrhage 24 hours post operative calculation of the number of the patients with blood loss \>1000 ml
amount of postoperative blood loss 24 hours post operative measure amount of blood loss post operative in ml by gravimetric methods
Trial Locations
- Locations (1)
Aswan University
🇪🇬Aswan, Egypt