Impact of Uterotonic Agents on Isolated Human Myometrium

Postpartum Hemorrhage Clinical Trial

Official title:

Impact of Uterotonic Agents on Isolated Human Myometrium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00989027
• Other study ID #: 07-08
• Status: Completed
• Phase: N/A
• First received: July 29, 2009
• Last updated: February 19, 2014
• Start date: June 2007
• Est. completion date: August 2013

Study information

• Verified date: February 2014
• 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 a sample of uterine muscle tissue to contract in the presence of various drugs. The drugs studied are typically used to contract the uterus when a pregnant patient continues to bleed after delivery. Amongst the uterotonic drugs (used to contract the uterus), namely oxytocin, ergonovine and carboprost, the most effective one to use is not known.

The investigators will be testing uterine muscle samples in the presence of these drugs at various concentrations, to see what their contractility measures over time, as compared with a control sample, in which no drugs will be applied.

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 for the ability to contract after treatment with various uterotonic drugs (oxytocin, ergonovine and carboprost) in the laboratory. This information will help us know the effect of these drugs by comparing the contractile capability of the uterine tissue.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• 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 Cesarean section

• Cesarean section under spinal anesthesia

Exclusion Criteria:

• Patients who require general anesthesia

• Patient who had previous uterine surgery or Cesarean section

• Patients with placental anomalies

• Emergency Cesarean section in labor

• Patients with bleeding disorders

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, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
• Ergonovine
Ergonovine, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
• Carboprost
Carboprost, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
• Oxytocin and Ergonovine
Oxytocin and Ergonovine, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
• Oxytocin and Carboprost
Oxytocin and Carboprost, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

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