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

This study is currently recruiting participants.
Verified February 2014 by St. Luke's-Roosevelt Hospital Center
Sponsor:
Information provided by (Responsible Party):
Graham Ashmead, St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT00212446
First received: September 13, 2005
Last updated: February 28, 2014
Last verified: February 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
  • No fetal heart arrhythmias [ Time Frame: 20 minutes ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Increased latency of birth [ Time Frame: Time until delivery ] [ Designated as safety issue: Yes ]
  • Decreased pain during the birthing process [ Time Frame: Until birthing process is complete ] [ Designated as safety issue: No ]
  • Normal Apgars [ Time Frame: Until after childbirth ] [ Designated as safety issue: Yes ]
  • Normal newborn [ Time Frame: until after childbirth ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: September 2004
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 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 control period 1(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 control period 1(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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00212446

Contacts
Contact: Jeffrey Karsdon, M.D 516-603-6668 jk_md@yahoo.com

Locations
United States, New York
St. Luke's-Roosevelt Hospital Center Recruiting
New York, New York, United States, 10019
Contact: Graham G. Ashmead, M.D.    212-523-6266    docmead@mac.com   
Contact: Carolyn R. Waldron, MS, MA    212-523-6201    cwaldron@chpnet.org   
Sub-Investigator: Jeffrey Karsdon, M.D.         
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Investigators
Principal Investigator: Graham G Ashmead, MD St. Luke's-Roosevelt Hospital Center
  More Information

No publications provided

Responsible Party: Graham Ashmead, Maternal-Fetal Medicine Faculty Attending, St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT00212446     History of Changes
Other Study ID Numbers: I123
Study First Received: September 13, 2005
Last Updated: February 28, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014