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

NCT00212446 | Completed Results

• 1 other identifier: 10-173
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preterm Birth

Keywords

Tocolysis; Electrical Pacemaker

Outcome Measures

Primary Outcomes (2)

• Uterine Contractions

  The first 20 minutes are the control contraction period (C1). The second 20 minutes are the EI period, with a 10-second burst of current administered just prior to each expected contraction; expected contractions are determined by the timing of the C1 contractions and/or by the rise of the subjective tocodynamometer tracing above baseline levels. The third 20 minutes is the post-intervention control contraction period (C2).

  20 minutes, 40 minutes, 60 minutes

• Number of Newborn With Fetal Heart Arrhythmias

  Number of newborn with fetal heart arrhythmias noted

  60 minutes

Secondary Outcomes (5)

• Latency of Birth

  Time until delivery, up to 4 weeks

• Pain During the Birthing Process

  Until birthing process is complete

• Apgars Score

  1 minute and 5 minute after childbirth

• The Length of NICU Stay

  up to one month

• Gestational Age at Discharge

  until after childbirth

Study Arms (1)

Electrical Intervention

EXPERIMENTAL

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)

Interventions

Electrical Intervention (EI) DEVICE

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).

Electrical Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pending preterm birth
• vaginal birth

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Luke's-Roosevelt Hospital Center: lead

Study Sites (1)

St. Luke's-Roosevelt Hospital Center

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Limitations and Caveats

it was difficult not only to obtain written informed consent from patients but also to convince their attending physicians to participate in study. Challenging to make researchers available when patients were in preterm labor and eligible for study.

Results Point of Contact

• Title: Dr. Jeffrey Karsdon
• Organization: New York Downtown Hospital (hospital bankrupt/closed)

JK_MD@yahoo.com

Study Officials

• Graham G Ashmead, MD

  St. Luke's-Roosevelt Hospital Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: February 1, 2005
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: December 17, 2018
• Results First Posted: December 17, 2018

Record last verified: 2018-12

Locations

US (1)