Current partner codePEPTIDESDE
NCT05758012·Not applicable·OBSERVATIONAL

Carbetocin Compared To Oxytocin During Cesarean Delivery

Status

Unknown

Phase

Not applicable

Enrollment

260

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

As both oxytocin and carbetocin are used daily in obstetric units all over the world, the investigators find it compelling to investigate whether the hemodynamic and myocardial effects of oxytocin and carbetocin are comparable in healthy women during delivery and determine any potential harmful effects following the use of oxytocin or Carbetocin as uterotonic. Other endpoints relating to uterus tone, blood loss, blood pressure, heart rate, post-operative pain and side effects will also be assessed.

Full detailed description

Although the difference between carbetocin and oxytocin in terms of hemodynamic changes, postpartum blood loss and incidence of side effects is not statistically significant. serious cardiovascular adverse events, including ST segment depression, hypotension and tachycardia have been reported after IV oxytocin. Oxytocin dose reduction and/or increased infusion duration may reduce risk of some cardiac-related adverse effects and increase patient safety. As both oxytocin and carbetocin are used daily in obstetric units all over the world, the investigators find it compelling to investigate whether the hemodynamic and myocardial effects of oxytocin and carbetocin are comparable in healthy women during delivery and determine any potential harmful effects following the use of oxytocin or Carbetocin as uterotonic. Other endpoints relating to uterus tone, blood loss, blood pressure, heart rate, post-operative pain and side effects will also be assessed.

Interventions

Treatment arms and agents.

DRUG

oxytocin

Participants will be randomized to receive Oxytocin after delivery of the baby's head and shoulders

DRUG

Carbetocin

Participants will be randomized to receive Cabetocin after delivery of the baby's head and shoulders

Timeline

From registration to results.

  1. First posted

    Mar 7, 2023

  2. Study start

    May 1, 2023

  3. Primary completion

    Nov 1, 2024

  4. Study completion

    Dec 1, 2024

  5. Results posted

    Not reported

  6. Registry updated

    Mar 7, 2023

Outcomes

What the study measures.

Primary outcomes

Myocardial effects

Time frame · immediately before drug administration

Electrocardiograph (QT interval)

Myocardial effects

Time frame · 24 hours after drug administration

Electrocardiograph (QT interval)

Secondary outcomes

Cardiac enzyme

Time frame · immediately before drug administration

Troponin

Cardiac enzyme

Time frame · 24 hours after drug administration

Troponin

Uterine contraction

Time frame · One hour post delivery

Palpate the fundus throughout a contraction to determine intensity

Eligibility

Who can take part.

Minimum age
16 Years
Maximum age
40 Years
Sex
FEMALE
Healthy volunteers
No

Inclusion Criteria: * Normal singleton pregnancy at gestational age of 36 weeks or more. * Women with common comorbid diagnoses (diabetes, hypothyroidism, hypertension) * pregnancy after in vitro fertilization Exclusion Criteria: * placenta praevia or invasive placenta. * pre-eclampsia. * Bleeding disorder, such as von Willebrand disease type I. * Current treatment with low-molecular-weight heparin or other anticoagulation medication (not including aspirin). * Any known intolerance to either of the study drugs. * Prolonged QT-time. * Other serious cardiac disease. * Liver or kidney failure.

Study locations

1 registered sites.

Kuwait. Showing up to 24 locations stored in the fast local snapshot.

Munistery of Health Kuwait

Kuwait City, Kuwait

Related trials

More studies on Carbetocin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.