NCT01689298

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
Last Updated

September 21, 2012

Status Verified

September 1, 2012

Enrollment Period

2.2 years

First QC Date

September 17, 2012

Last Update Submit

September 17, 2012

Conditions

Postpartum Hemorrhage

Keywords

Uterine contractionDose responseOxytocin pretreatmentOxytocinCarbetocin

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 drug pre-treatment

ACTIVE COMPARATOR

A control sample from each patient (no uterotonic drug will be applied during pre-treatment) will be measured concurrently with samples pre-treated with oxytocin. Controls will undergo the same dose response of oxytocin or carbetocin after pre-treatment period as the groups given oxytocin for pre-treatment.

Drug: OxytocinDrug: Carbetocin

Drug pre-treatment

ACTIVE COMPARATOR

A sample from each patient will be pre-treated with oxytocin 10-5mol/L. These samples will undergo the same dose response of oxytocin or carbetocin after pre-treatment period as the groups given no drug for pre-treatment (controls).

Drug: OxytocinDrug: Carbetocin

Interventions

OxytocinDRUG

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

Also known as: Pitocin
Drug pre-treatmentNo drug pre-treatment
CarbetocinDRUG

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

Also known as: Duratocin
Drug pre-treatmentNo drug pre-treatment

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (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 or first repeat Cesarean section
  • Cesarean section under spinal anesthesia

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Oxytocincarbetocin

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

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

September 17, 2012

First Posted

September 21, 2012

Study Start

January 1, 2010

Primary Completion

March 1, 2012

Study Completion

August 1, 2012

Last Updated

September 21, 2012

Record last verified: 2012-09

Locations

CA(1)