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NCT01262742·Not applicable·INTERVENTIONAL

Carbetocin at Elective Cesarean Delivery

CarbetocinOtherCompleted

Status

Completed

Phase

Not applicable

Enrollment

80

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most commonly uterotonic drug used to prevent and treat PPH in North America, however, there are some limitations to its use. Oxytocin has a very short duration of action, which requires a continuous infusion to achieve sustained uterotonic activity. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recently recommended a single 100mcg dose of carbetocin at elective Cesarean delivery to promote uterine contraction and prevent post partum hemorrhage (PPH), in lieu of the more traditional oxytocin regimens. Carbetocin lasts 4 to 7 times longer than oxytocin, with a similar side effect profile and apparent greater efficacy rate. However, a dose response to determine the minimum effective dose of carbetocin has not yet been published. We hypothesize that a dose-response study will establish the minimum dose of carbetocin required to produce appropriate contractility in 95% of the women (ED95) undergoing elective cesarean delivery.

Full detailed description

The Society of Obstetricians and Gynecologists of Canada (SOGC)recently recommended a 100mcg intravenous bolus dose of carbetocin following Cesarean delivery. However, a dose response study to determine the minimum effective dose of carbetocin has not yet been published. Studies thus far show that carbetocin may be just as effective as oxytocin in promoting uterine contraction, with a similar side effects profile. In addition, patients receiving carbetocin may experience less blood loss, and require less additional uterotonics when compared with oxytocin. The results of this study will define the minimum required dose of carbetocin for uterine contraction, thus minimizing unnecessary side effects, improving quality and safety of patient care. It may also contribute in establishing carbetocin as a substitute to oxytocin for elective cesarean section at our institution as well as others.

Interventions

Treatment arms and agents.

DRUG

Carbetocin

80mcg carbetocin, IV, over 1 minute following delivery of the fetal head.

DRUG

Carbetocin

90mcg carbetocin, IV, over 1 minute following delivery of the fetal head.

DRUG

Carbetocin

100mcg carbetocin, IV, over 1 minute following delivery of the fetal head.

DRUG

Carbetocin

110mcg carbetocin, IV, over 1 minute following delivery of the fetal head.

DRUG

Carbetocin

120mcg carbetocin, IV, over 1 minute following delivery of the fetal head.

Timeline

From registration to results.

  1. First posted

    Dec 17, 2010

  2. Study start

    Nov 2010

  3. Primary completion

    Mar 2011

  4. Study completion

    Mar 2011

  5. Results posted

    Not reported

  6. Registry updated

    Apr 25, 2025

Outcomes

What the study measures.

Primary outcomes

Uterine tone.

Time frame · 2 minutes

The obstetrician will assess uterine tone by palpation. Uterine tone will be rated as satisfactory (firm) or unsatisfactory (boggy).

Secondary outcomes

Uterine tone

Time frame · 2 hours

Uterine tone will be assessed by palpation 2 hours post-delivery by the nurse/obstetrician in the recovery room.

Blood loss

Time frame · 48 hours

Blood loss will be calculated through the difference in hematocrit values assessed prior to and at the end of 48 hours after the cesarean section.

Side effects

Time frame · 2 hours

Any of the following will be noted up to 2 hours post delivery: systolic blood pressure \< 80% of pre-delivery values, tachycardia \> 30% pre-delivery levels, bradycardia \< 30% pre-delivery levels, other dysrhythmias, nausea, vomiting, chest pain, shortness of breath, headache, flushing, others

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
50 Years
Sex
FEMALE
Healthy volunteers
Yes

Inclusion Criteria: * All patients planned for elective cesarean delivery under spinal anesthesia; * All patients who gave written informed consent to participate in this study. Exclusion Criteria: * All patients who refuse to give written informed consent. * All patients who claim allergy or hypersensitivity to carbetocin or oxytocin. * All patients with conditions that predispose to uterine atony and postpartum hemorrhage such as placenta previa, multiple gestation, preeclampsia, eclampsia, macrosomia, polyhydramnios, uterine fibroids, previous history of uterine atony and postpartum bleeding, or bleeding diathesis. * All patients with hepatic, renal, and vascular disease, * All patients requiring general anesthesia prior to the administration of the study drug.

Study locations

1 registered sites.

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

Mount Sinai Hospital

Toronto, Ontario, Canada

Publications

Results and literature.

PMID 22717890 ↗Cordovani D, Balki M, Farine D, Seaward G, Carvalho JC. Carbetocin at elective Cesarean delivery: a randomized controlled trial to determine the effective dose. Can J Anaesth. 2012 Aug;59(8):751-7. doi: 10.1007/s12630-012-9728-2. Epub 2012 Jun 21.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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.

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