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Pilot Study of Electronic Uterine Contraction Inhibitor

NCT00994058 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2015-12-24

No results posted yet for this study

Summary

The objective is to test a novel paradigm for the inhibition of human preterm uterine contractions.

The study hypothesis is that human preterm contractions can be safely inhibited with a weak electrical current provided by an electrical inhibition/uterine pacemaker device.

Preterm birth is still a major problem. Current methods of preventing the uterine contractions of preterm are limited and associated with many side-effects affecting both the mother and baby. A reliable method of preventing preterm uterine contractions would be an important discovery. Such a method could eventually lead to a long-term goal of decreasing neonatal morbidity and mortality.

Conditions

  • Prematurity

Interventions

DEVICE

Electrical Inhibition (EI) Uterine Pacemaker

An external powered pulse generator, pacemaker for external stimulation of the uterine muscle through the vaginal canal for the therapeutic use of preventing preterm birth. Patients with preterm contractions (\< 37 weeks gestation) will be monitored for contraction frequency for 20 minutes before, 20 minutes during use of EI and 20 minutes after EI/uterine inhibitor/pacemaker. Device generates a weak electrical current (0-10mA, 0-50 Hz, 0-50mS).

Sponsors & Collaborators

  • Winthrop University Hospital

    lead OTHER

Principal Investigators

  • Graham G Ashmead, MD · Winthrop University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States

Study Locations

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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 NCT00994058 on ClinicalTrials.gov