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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT00212446
First received: September 13, 2005
Last updated: November 19, 2015
Last verified: October 2015
  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 ]

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: September 13, 2005
Last Updated: November 19, 2015
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 September 30, 2016