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Pilot Study to Evaluate a Prototype Electronic Uterine Inhibitor to Prevent Preterm Contractions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00212446
First Posted: September 21, 2005
Last Update Posted: November 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
  Purpose
Use an electrical-inhibition (EI)/uterine pacemaker device similar to an electrical heart pacemaker to deliver a weak electrical current to the human uterus that will rapidly and safely inhibit the unwanted premature uterine contractions of preterm birth.

Condition Intervention
Preterm Birth Device: Electrical Intervention (EI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pilot Study to Evaluate a Prototype Electronic Uterine Inhibitor to Prevent Preterm Contractions

Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • Decreased uterine contractions [ Time Frame: 20 minutes ]
  • No fetal heart arrhythmias [ Time Frame: 20 minutes ]

Secondary Outcome Measures:
  • Increased latency of birth [ Time Frame: Time until delivery ]
  • Decreased pain during the birthing process [ Time Frame: Until birthing process is complete ]
  • Normal Apgars [ Time Frame: Until after childbirth ]
  • Normal newborn [ Time Frame: until after childbirth ]

Enrollment: 8
Study Start Date: September 2014
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Electrical Intervention
Electrical intervention (EI) is bipolar, constant-current (1-20 mA), square-wave pulses in 20% duty cycles. Women in preterm labor have an electrode placed vaginally; tocodynamometric contraction timing and fetal heart rate are monitored continuously. Successive 20-minute periods include pre-control period (C1); the EI period, in which a 10-second current burst is delivered at expected contraction times; and a post-EI control period (C2).
Device: Electrical Intervention (EI)
Electrical intervention (EI) is bipolar, constant-current (1-20 mA), square-wave pulses in 20% duty cycles. Women in preterm labor have an electrode placed vaginally; tocodynamometric contraction timing and fetal heart rate are monitored continuously. Successive 20-minute periods include pre-control period (C1); the EI period, in which a 10-second current burst is delivered at expected contraction times; and a post-EI control period (C2).

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pending preterm birth
  • vaginal birth

Exclusion Criteria:

  • disease disorders including but not limited to thyroid, liver disease, HIV, diabetes or drug addiction
  • using a permanent cardiac pacemaker
  • have malignancies that are currently being treated or recurrent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00212446


Locations
United States, New York
St. Luke's-Roosevelt Hospital Center
New York, New York, United States, 10019
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Investigators
Principal Investigator: Graham G Ashmead, MD St. Luke's-Roosevelt Hospital Center
  More Information

Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT00212446     History of Changes
Other Study ID Numbers: I123
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: November 20, 2015
Last Verified: October 2015

Keywords provided by St. Luke's-Roosevelt Hospital Center:
Tocolysis
Electrical Pacemaker

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications