Carbetocin Versus Oxytocin Infusion Plus Tranexamic Acid During Cesarean Section

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03777878
• Other study ID #: aswu/186/18
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: May 1, 2021

Study information

• Verified date: February 2019
• Source: Aswan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 1, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

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
• oxytocin
20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby
• TA
2 ampoules of TA in 100 ml saline by slow infusion
• 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
• placebo to TA
2 placebo ampoules to TA in 100 ml saline by slow infusion
• placebo to oxytocin
two placebo ampoules to oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby

Locations

Country	Name	City	State
Egypt	Aswan University	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

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