Pilot Study of Electronic Uterine Contraction Inhibitor

NCT00994058 | Withdrawn Phase 1

• 1 other identifier: 09034
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Preterm Labor; Uterine Inhibitor; Electro-Inhibition

Outcome Measures

Primary Outcomes (1)

• Contraction frequency

  60 minutes

Secondary Outcomes (1)

• Preterm birth

  24 hours

Study Arms (1)

Intevention with Inhibitor

EXPERIMENTAL

Device: Electrical Inhibition (EI) Uterine Pacemaker

Interventions

Electrical Inhibition (EI) Uterine Pacemaker DEVICE

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).

Intevention with Inhibitor

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• to 34 weeks pregnant
• preterm labor
• at least one contraction every 5 minutes for 30 minutes
• \> 3 cm cervical dilation; \> 80% cervical effacement
• Have received tocolysis therapy
• Anticipate a normal spontaneous vaginal delivery (NSVD)
• Be at least 18 years of age
• Have signed a written informed consent document
• Be willing and able to comply with study requirements

You may not qualify if:

• Severe preeclampsia
• Severe abruption placenta
• Rupture of amnionic membranes
• Frank chorioamnionitis
• Fetal death
• Fetal anomaly incompatible with life
• Severe fetal growth restriction (estimated fetal weight \<5%)
• Mature fetal lung studies
• Maternal cardiac arrythmias
• A permanent cardiac pacemaker
• A fetal cardiac arrhythmia

Sponsors & Collaborators

• Winthrop University Hospital: lead

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Related Publications (1)

• Karsdon J, Garfield RE, Shi SQ, Maner W, Saade G. Electrical inhibition of preterm birth: inhibition of uterine contractility in the rabbit and pup births in the rat. Am J Obstet Gynecol. 2005 Dec;193(6):1986-93. doi: 10.1016/j.ajog.2005.05.009.

  PMID: 16325601 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

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

Study Officials

• Graham G Ashmead, MD

  Winthrop University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 7, 2009
• First Posted: October 14, 2009
• Study Start: October 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: December 24, 2015

Record last verified: 2015-12

Locations

US (1)