Impact of Uterotonic Agents on Isolated Human Myometrium

NCT00989027 | Completed

• 1 other identifier: 07-08
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postpartum Hemorrhage

Keywords

Uterine contraction; Dose-response; Oxytocin pre-treatment

Outcome Measures

Primary Outcomes (1)

• Amplitude of contraction

  6-8 hours

Secondary Outcomes (3)

• Integrated area under response curve (AUC)

  6-8 hours

• Basal tone

  6-8 hours

• Frequency of contraction

  6-8 hours

Study Arms (2)

No treatment

NO INTERVENTION

A control sample from each patient (no uterotonic drug applied) will be measured concurrently with samples treated with various drugs.

Treatment

ACTIVE COMPARATOR

Samples from each patient will be bathed in solutions containing varying concentrations of either oxytocin, carboprost and ergonovine, and contractility will be measured.

Drug: Oxytocin; Drug: Ergonovine; Drug: Carboprost; Drug: Oxytocin and Ergonovine; Drug: Oxytocin and Carboprost

Interventions

Oxytocin DRUG

Oxytocin, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.

Treatment

Ergonovine DRUG

Ergonovine, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.

Also known as: Ergonovine Maleate

Treatment

Carboprost DRUG

Carboprost, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.

Also known as: Hemabate

Treatment

Oxytocin and Ergonovine DRUG

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

Also known as: Oxytocin, Ergonovine

Treatment

Oxytocin and Carboprost DRUG

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

Also known as: Oxytocin, Hemabate

Treatment

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Gestational age 37-41 weeks
• Non-laboring patients, not exposed to exogenous oxytocin
• Patients requiring primary Cesarean section
• Cesarean section under spinal anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Oxytocin; Ergonovine; Carboprost; carboprost tromethamine

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Mrinalini Balki, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2009
• First Posted: October 2, 2009
• Study Start: June 1, 2007
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: February 20, 2014

Record last verified: 2014-02

Locations

CA (1)