Clinical trial NCT03777878: Carbetocin Versus Oxytocin Infusion Plus Tranexamic Acid During Cesarean Section
Official title: Carbetocin Versus Oxytocin Infusion Plus Tranexamic Acid for Prevention of Postpartum Hemorrhage at Cesarean Section: A Double-Blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Section Complications
Keywords: cesarean section
tranexamic acid
oxytocin
carbetocin
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Double-Blind Randomized Clinical Trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The number of the patient need of additional pharmacological uterotonic.
timeFrame: 24 hours post operative
Secondary outcomes:
measure: estimation of intraoperative blood loss (ml)
timeFrame: during the operation
measure: amount of postoperative blood loss
timeFrame: 24 hours post operative
measure: number of patient with postpartum hemorrhage
timeFrame: 24 hours post operative
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University
Study officials:
References: