Carbetocin Versus Oxytocin Infusion Plus Tranexamic Acid During Cesarean Section

Aswan University Hospital

Status: Unknown

Conditions: Cesarean Section Complications

Treatments: Drug: placebo to TA; Drug: Carbetocin; Drug: placebo to carbetocin; Drug: oxytocin; Drug: placebo to oxytocin; Drug: TA

Study type: Interventional

Funder types: Other

Identifiers

NCT03777878

aswu/186/18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 3 patient groups

Carbetocin plus placebo to TA and placebo to oxytocin

Active Comparator group

Description:

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

Treatment:

Drug: placebo to oxytocin

Drug: Carbetocin

Drug: placebo to TA

oxytocin plus TA

Active Comparator group

Description:

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

Treatment:

Drug: TA

Drug: oxytocin

Drug: placebo to carbetocin

oxytocin plus placebo to TA and placebo to carbetocin

Active Comparator group

Description:

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

Treatment:

Drug: oxytocin

Drug: placebo to carbetocin

Drug: placebo to TA