Carbetocin Versus Oxytocin Infusion Plus Tranexamic Acid During Cesarean Section

Carbetocin Versus Oxytocin Infusion Plus Tranexamic Acid for Prevention of Postpartum Hemorrhage at Cesarean Section: A Double-Blind Randomized Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Drug: Carbetocin; Drug: placebo to TA; Drug: placebo to oxytocin; Drug: oxytocin; Drug: TA; Drug: placebo to carbetocin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Aswan, Egypt, 81528
    • Recruiting
    • Aswan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Carbetocin plus placebo to TA and 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	Drug: Carbetocin; 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; Other Names: Active Comparator; Drug: placebo to TA; 2 placebo ampoules to TA in 100 ml saline by slow infusion; Other Names: placebo comparator; Drug: placebo to oxytocin; two placebo ampoules to oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby; Other Names: placebo comparator
Active Comparator: oxytocin plus 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	Drug: oxytocin; 20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby; Other Names: Active Comparator; Drug: TA; 2 ampoules of TA in 100 ml saline by slow infusion; Other Names: active comparator; Drug: placebo 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; Other Names: placebo comparator
Active Comparator: oxytocin plus placebo to TA and 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	Drug: placebo to TA; 2 placebo ampoules to TA in 100 ml saline by slow infusion; Other Names: placebo comparator; Drug: oxytocin; 20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby; Other Names: Active Comparator; Drug: placebo 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; Other Names: placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of the patient need of additional pharmacological uterotonic.	calculate the number of the patient need of additional pharmacological uterotonic.	24 hours post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
estimation of intraoperative blood loss (ml)	measure Intraoperative blood loss in ml by gravimetric methods	during the operation
amount of postoperative blood loss	measure amount of blood loss post operative in ml by gravimetric methods	24 hours post operative
number of patient with postpartum hemorrhage	calculation of the number of the patients with blood loss >1000 ml	24 hours post operative

Collaborators and Investigators

• Sponsor: Aswan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): March 30, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: December 14, 2018
• First Submitted That Met QC Criteria: December 14, 2018
• First Posted (Actual): December 17, 2018

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 14, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: cesarean section; oxytocin; tranexamic acid; carbetocin
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin; Carbetocin
• Other Study ID Numbers: aswu/186/18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No