MedTrace Logo

Carbetocin at Elective Cesarean Delivery Part 2

NCT01428817 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2012-03-26

No results posted yet for this study

Summary

Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most common 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. The investigators hypothesize that the minimum effective dose (ED90) is above 20mcgs and below 80mcgs in women undergoing elective Cesarean delivery.

Conditions

  • Postpartum Hemorrhage

Interventions

DRUG

Carbetocin

20mcg carbetocin, IV, over 1 minute following delivery of the fetal head.

DRUG

Carbetocin

40mcg carbetocin, IV, over 1 minute following delivery of the fetal head.

DRUG

Carbetocin

60mcg carbetocin, IV, over 1 minute following delivery of the fetal head.

DRUG

Carbetocin

80mcg 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.

Sponsors & Collaborators

  • Samuel Lunenfeld Research Institute, Mount Sinai Hospital

    lead OTHER

Principal Investigators

  • Jose CA Carvalho, MD · MOUNT SINAI HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01428817 on ClinicalTrials.gov