Cesarean Section Complications
Conditions
Keywords
cesarean section, tranexamic acid, oxytocin, carbetocin
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.
Interventions
DRUGCarbetocin
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
DRUGoxytocin
20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby
DRUGTA
2 ampoules of TA in 100 ml saline by slow infusion
DRUGplacebo 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
DRUGplacebo to TA
2 placebo ampoules to TA in 100 ml saline by slow infusion
DRUGplacebo to oxytocin
two placebo ampoules to oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby
Sponsors
Aswan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
A Double-Blind Randomized Clinical Trial
Intervention model description
A Double-Blind Randomized Clinical Trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| estimation of intraoperative blood loss (ml) | during the operation | measure Intraoperative blood loss in ml by gravimetric methods |
| amount of postoperative blood loss | 24 hours post operative | measure amount of blood loss post operative 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 |
Countries
Egypt
Outcome results
None listed