In Vitro Myometrial Contractions in Laboring and Non-laboring Women

NCT01689311 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2012-09-21

No results posted yet for this study

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. Amongst common uterotonic drugs, namely oxytocin, ergonovine, prostaglandin F2alpha, and misoprostol, the most effective one to use is unknown.

The investigators will be testing isolated uterine muscle samples to increasing concentrations of these four drugs in three patient populations: non-laboring, laboring without exogenous oxytocin augmentation, and laboring with oxytocin augmentation. Contractile measures will be measured and compared between all groups. The investigators hypothesize that oxytocin alone will have a weaker uterotonic effect in oxytocin-augmented laboring patients, and all four drugs will induce different patterns of contractions.

Conditions

  • Postpartum Hemorrhage

Interventions

DRUG

Oxytocin

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

DRUG

Ergonovine

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

DRUG

Prostaglandin F2alpha

Prostaglandin F2alpha, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.

DRUG

Misoprostol

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

Sponsors & Collaborators

  • University of Toronto

    collaborator OTHER
  • Canadian Anesthesiologists' Society

    collaborator OTHER
  • Samuel Lunenfeld Research Institute, Mount Sinai Hospital

    lead OTHER

Principal Investigators

  • Mrinalini Balki, MD · MOUNT SINAI HOSPITAL

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-08-31
Completion
2012-08-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01689311 on ClinicalTrials.gov