Carbetocin Versus Oxytocin Infusion Plus Tranexamic Acid During Cesarean Section

NCT ID: NCT03777878

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2021-05-01

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.

Conditions

Cesarean Section Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Carbetocin

Intervention Type: DRUG

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

placebo to TA

Intervention Type: DRUG

2 placebo ampoules to TA in 100 ml saline by slow infusion

placebo to oxytocin

Intervention Type: DRUG

two placebo ampoules to oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby

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

Group Type: ACTIVE_COMPARATOR

oxytocin

Intervention Type: DRUG

20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby

TA

Intervention Type: DRUG

2 ampoules of TA in 100 ml saline by slow infusion

placebo to carbetocin

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

oxytocin

Intervention Type: DRUG

20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby

placebo to carbetocin

Intervention Type: DRUG

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

Intervention Type: DRUG

2 placebo ampoules to TA in 100 ml saline by slow infusion

Interventions

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

Intervention Type: DRUG

oxytocin

20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby

Intervention Type: DRUG

TA

2 ampoules of TA in 100 ml saline by slow infusion

Intervention Type: 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

Intervention Type: DRUG

placebo to TA

2 placebo ampoules to TA in 100 ml saline by slow infusion

Intervention Type: DRUG

placebo to oxytocin

two placebo ampoules to oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby

Intervention Type: DRUG

Other Intervention Names

Active Comparator; Active Comparator; active comparator; placebo comparator; placebo comparator; placebo comparator

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aswan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

hany farouk

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aswan University

Aswān, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

hany f sallam, md

Role: primary

nahla.elsayed@aswu.ed.eg

01092440504 ext. 002

Nahla w Shady, md

Role: backup

nahla.elsayed@aswu.edu.eg

1019240504 ext. 002

Other Identifiers

aswu/186/18

Identifier Type: -

Identifier Source: org_study_id