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

Postpartum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01689298
• Other study ID #: 12-05
• Secondary ID: 11-0257-E
• Status: Completed
• Phase: N/A
• First received: September 17, 2012
• Last updated: September 17, 2012
• Start date: January 2010
• Est. completion date: August 2012

Study information

• Verified date: September 2012
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Gestational age 37-41 weeks

• Non-laboring patients, not exposed to exogenous oxytocin

• Patients requiring primary or first repeat Cesarean section

• Cesarean section under spinal anesthesia

Exclusion Criteria:

• Patients who require general anesthesia

• Patient who had previous myometrial surgery or more than one previous Cesarean section

• Patients with placental anomalies

• Emergency Cesarean section in labor

• Patients with multiple pregnancy (twins, etc.)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postpartum Hemorrhage

Intervention

Drug:
• Oxytocin
Oxytocin, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
• Carbetocin
Carbetocin, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital	University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amplitude of contraction		6-8 hours	No
Secondary	Integrated area under response curve (AUC)		6-8 hours	No
Secondary	Basal tone		6-8 hours	No
Secondary	Frequency of contraction		6-8 hours	No