PrematurityPhase 1PSEUCINCT00994058
Pilot Study of Electronic Uterine Contraction Inhibitor
A Phase 1 study testing Electrical Inhibition (EI) Uterine Pacemaker in people with Prematurity, run by Winthrop University Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Prematurity
- What is being tested?
- Electrical Inhibition (EI) Uterine Pacemaker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Aug 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 24 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)
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- Be at least 18 years of age
- Have signed a written informed consent document
- Be willing and able to comply with study requirements
Who cannot join
- Severe preeclampsia
- Severe abruption placenta
- Rupture of amnionic membranes
- Frank chorioamnionitis
- Fetal death
- Fetal anomaly incompatible with life
Show all 11Show fewer
- Severe fetal growth restriction (estimated fetal weight <5%)
- Mature fetal lung studies
- Maternal cardiac arrythmias
- A permanent cardiac pacemaker
- A fetal cardiac arrhythmia
Trial locations and contacts
1 site in 1 country.
United States1 site
Winthrop University Hospital
Mineola, New York, 11501
About this study
Official title: Pilot Study to Evaluate A Prototype Electronic Uterine Inhibitor to Prevent Preterm Contractions
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.
Read the 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.
RISK:
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.
BENEFIT:
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.
- Conditions
- Prematurity
- Being tested
- Electrical Inhibition (EI) Uterine Pacemaker
- Keywords
- Preterm Labor, Uterine Inhibitor, Electro-Inhibition
- Medical subject headings
- Premature Birth, Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Inhibition (EI) Uterine PacemakerDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Intevention with Inhibitor | Experimental | Not described Receives: Device: Electrical Inhibition (EI) Uterine Pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contraction frequency
Measured: 60 minutes
Secondary outcomes (1)
Preterm birth
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionAug 2010
- Study completionAug 2010
Why it stopped: The Investigator has changed institutions.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winthrop University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Graham G Ashmead, MD, Principal investigator, Winthrop University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994058
- Sponsor's protocol ID
- 09034
- Acronym
- PSEUCI
- Status last verified
- Dec 2015
- First submitted
- 7 Oct 2009
- Last updated
- 24 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16325601
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate A Prototype Electronic Uterine Inhibitor to Prevent Preterm Contractions
- ClinicalTrials.gov ID
- NCT00994058
- Acronym / sponsor ID
- PSEUCI / 09034
- Conditions
- Prematurity
- Keywords
- Preterm Labor, Uterine Inhibitor, Electro-Inhibition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The Investigator has changed institutions.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Winthrop University HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 14 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
RISK:
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.
BENEFIT:
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intevention with Inhibitor | Experimental | Device: Electrical Inhibition (EI) Uterine Pacemaker |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 24 to 34 weeks pregnant
- preterm labor
- Have received tocolysis therapy
- Anticipate a normal spontaneous vaginal delivery (NSVD)
- Be at least 18 years of age
Key exclusion criteria (11 listed)
- Severe preeclampsia
- Severe abruption placenta
- Rupture of amnionic membranes
- Frank chorioamnionitis
- Fetal death
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical Inhibition (EI) Uterine PacemakerAn 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). | Device | Intevention with Inhibitor |
Primary outcome
Contraction frequency
Time frame: 60 minutes
1 secondary outcome
Preterm birth
Time frame: 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2015.
- Background: PubMed 16325601Karsdon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graham G Ashmead, MD principal investigator
Winthrop University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Electrical Inhibition (EI) Uterine Pacemaker in people with Prematurity, run by Winthrop University Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contraction frequency (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00994058, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2015.