Clinical Trials Directory

Trials / Completed

CompletedNCT01689298

Carbetocin vs. Oxytocin: In-vitro Myometrial Contractions With and Without Oxytocin Pre-treatment

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Academic / Other
Sex
Female
Age
Healthy volunteers
Accepted

Summary

The purpose of this study is to compare the ability of an isolated sample of uterine muscle tissue (in a tissue bath) to contract in the presence of various drugs. The drugs studied--uterotonics--are typically used to contract the uterus when a pregnant patient continues to bleed after delivery. Oxytocin is an old standard, but seems to suffer from a desensitization phenomenon. Carbetocin, a similar drug, has recently been suggested to clinicians as a replacement for oxytocin directly after certain types of Cesarean section. The investigators will be testing isolated uterine muscle samples after pre-treatment with oxytocin OR nothing (control) to increasing concentrations of oxytocin OR carbetocin. Contractile measures will be measured and compared between all groups. The investigators hypothesize that oxytocin pre-treatment will reduce contractions in both oxytocin- and carbetocin-induced contractions, and oxytocin and carbetocin will induce different patterns of contractions.

Detailed description

Postpartum hemorrhage (PPH) is a major cause of maternal mortality and morbidity. In 80% cases of PPH, the primary cause is failure of the uterus to contract after delivery of the baby, which then requires further treatment of the mother with uterotonic drugs (drugs used to contract uterus and thus prevent bleeding). Patients participating in this study will be asked to donate a very small sample of uterine tissue during Cesarean section, which will be tested in the laboratory for the ability to contract in response to the uterotonics oxytocin and carbetocin. We will seek to better understand the effects of these drugs by comparing their contractile capability in isolated uterine tissue.

Conditions

Interventions

TypeNameDescription
DRUGOxytocinOxytocin, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
DRUGCarbetocinCarbetocin, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.

Timeline

Start date
2010-01-01
Primary completion
2012-03-01
Completion
2012-08-01
First posted
2012-09-21
Last updated
2012-09-21

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT01689298. Inclusion in this directory is not an endorsement.