Carbetocin Versus Oxytocin Infusion Plus Tranexamic Acid During Cesarean Section

NCT03777878 | Unknown DMC

• 1 other identifier: aswu/186/18
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section Complications

Keywords

cesarean section; tranexamic acid; oxytocin; carbetocin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• estimation of intraoperative blood loss (ml)

  during the operation

• amount of postoperative blood loss

  24 hours post operative

• number of patient with postpartum hemorrhage

  24 hours post operative

Study Arms (3)

Carbetocin plus placebo to TA and placebo to oxytocin

ACTIVE COMPARATOR

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; Drug: placebo to TA; Drug: placebo to oxytocin

oxytocin plus TA

ACTIVE COMPARATOR

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; Drug: TA; Drug: placebo to carbetocin

oxytocin plus placebo to TA and placebo to carbetocin

ACTIVE COMPARATOR

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

Interventions

Carbetocin 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

Also known as: Active Comparator

Carbetocin plus placebo to TA and placebo to oxytocin

oxytocin DRUG

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

Also known as: Active Comparator

oxytocin plus TA; oxytocin plus placebo to TA and placebo to carbetocin

TA DRUG

2 ampoules of TA in 100 ml saline by slow infusion

Also known as: active comparator

oxytocin plus TA

placebo to carbetocin 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

Also known as: placebo comparator

oxytocin plus TA; oxytocin plus placebo to TA and placebo to carbetocin

placebo to TA DRUG

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

Also known as: placebo comparator

Carbetocin plus placebo to TA and placebo to oxytocin; oxytocin plus placebo to TA and placebo to carbetocin

placebo to oxytocin DRUG

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

Also known as: placebo comparator

Carbetocin plus placebo to TA and placebo to oxytocin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women who undergo elective cesarean section with one or more risk factors for PPH were the candidates for participation
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University

Aswān, 81528, Egypt

RECRUITING

MeSH Terms

Interventions

carbetocin; Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A Double-Blind Randomized Clinical Trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A Double-Blind Randomized Clinical Trial

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 17, 2018
• Study Start: January 1, 2019
• Primary Completion: March 30, 2021
• Study Completion: May 1, 2021
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

EG (1)