Pilot Study of Electronic Uterine Contraction Inhibitor (PSEUCI)

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. Identifier: NCT00994058
Recruitment Status : Withdrawn (The Investigator has changed institutions.)
First Posted : October 14, 2009
Last Update Posted : December 24, 2015
Information provided by:
Winthrop University Hospital

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.

Condition or disease Intervention/treatment Phase
Prematurity Device: Electrical Inhibition (EI) Uterine Pacemaker Phase 1

Detailed Description:

The study design is a Pilot Study to confirm the safety of the uterine inhibitor/pacemaker and measure its effect on women experiencing preterm labor.

A total of 10 (ten) patients will be enrolled in this pilot study to confirm the methodology and safety of the device. Patients who meet the inclusion criteria and none of the exclusion criteria will be recruited for the study.

The study device (EI/uterine inhibitor/pacemaker) has been classified by FDA as an Investigational Device Exemption (IDE) number G080036, Class A device. The EI/uterine inhibitor/pacemaker device is FDA cleared for research of the prevention of the prevention of the human contractions of preterm birth.

This proposal is for an initial prospective FDA approved pilot study. After FDA evaluation of the pilot study findings and approval, the pilot study may lead eventually to a prospective randomized controlled clinical study.

Only adult women who are experiencing uterine contractions due to the birthing process are eligible.

Study patients will be informed about the purpose of the EI/uterine inhibitor/pacemaker device and give informed consent prior to its use. The device will be used for only 20 minutes, preceded and followed by a 20 minute control period.

During the birthing process recordings of the uterine contractions will be recorded. Comparison will be made of these uterine contraction records pre and post use use of the EI/uterine inhibitor/pacemaker device. The uterine contraction tracings will be compared and analyzed for differences in the frequency of contractions.

The patients will also be told how to express the strength of any of their subjective pain in a manner that can be documented in a questionnaire. Study patients will also have their record of the type and amount of pain medication they have received noted on their patient log forms.


Previous human and animal studies indicate minimal risk to either baby or mother. Human studies showed no effect on the fetal or maternal heart rate. Real-time monitoring of the fetal and maternal heart rate during the study will protect against there potential risks.


Reducing the frequency of preterm uterine contractions is a first step to preventing preterm birth,but the proposed investigation is not, itself, expected to prevent any preterm births. However, the investigation could have great benefit to future mothers and their babies.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Pilot Study to Evaluate A Prototype Electronic Uterine Inhibitor to Prevent Preterm Contractions
Study Start Date : October 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Arm Intervention/treatment
Experimental: Intevention with Inhibitor Device: Electrical Inhibition (EI) Uterine Pacemaker

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).

Primary Outcome Measures :
  1. Contraction frequency [ Time Frame: 60 minutes ]

Secondary Outcome Measures :
  1. Preterm birth [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 24 to 34 weeks pregnant
  2. preterm labor

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

Exclusion Criteria:

  1. Severe preeclampsia
  2. Severe abruption placenta
  3. Rupture of amnionic membranes
  4. Frank chorioamnionitis
  5. Fetal death
  6. Fetal anomaly incompatible with life
  7. Severe fetal growth restriction (estimated fetal weight <5%)
  8. Mature fetal lung studies
  9. Maternal cardiac arrythmias
  10. A permanent cardiac pacemaker
  11. A fetal cardiac arrhythmia

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 identifier (NCT number): NCT00994058

United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
Sponsors and Collaborators
Winthrop University Hospital
Principal Investigator: Graham G Ashmead, MD Winthrop University Hospital

Responsible Party: Graham Gaylord Ashmead, MD, Dept OB/GYN, Winthrop University Hospital Identifier: NCT00994058     History of Changes
Other Study ID Numbers: 09034
First Posted: October 14, 2009    Key Record Dates
Last Update Posted: December 24, 2015
Last Verified: December 2015

Keywords provided by Winthrop University Hospital:
Preterm Labor
Uterine Inhibitor