Preterm LaborNCT02983240
Electrical Inhibition of Human Preterm Contractions
A study testing Electrical Uterine Pacemaker in people with Preterm Labor and PreTerm Birth, run by e-Bio Corp at 1 site in United States.
Trial summary
The purpose of this study is to explore a new method to stop preterm uterine contractions using an electrical device. The device, an "electrical pacemaker for the uterus," has been approved by the Food and Drug Administration (FDA) for clinical research in pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Labor, PreTerm Birth, Preterm Labor With Delivery Nos
- What is being tested?
- Electrical Uterine Pacemaker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 21 Jan 2026
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Wong-Baker pain score ≤ 6
- Pregnancy Depression Scale score < 16
- Informed consent form signed and dated by patient
- Be willing and able to comply with study requirements
- Be between 18-50 years of age
- Be between 23 to 36 5/7 weeks pregnant with a singleton gestation
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- Cervical dilation of ≤ 6 cm
- A normal spontaneous vaginal delivery (NSVD) expected
- Suspected to have preterm labor, as defined by the American College of Obstetricians and Gynecologists and the American Academy of Pediatrics, as follows.78
- Persistent uterine contractions (4 every 20 minutes, or 8 every 60 minutes)
- And any one or more of the following:
- Documented cervical change
- 1 cm cervical dilatation and progressing
- -> 80% cervical effacement
- Be admitted to the maternity unit with the diagnosis of preterm labor or preterm contractions
Who cannot join
- Severe preeclampsia
- Severe abruption placenta
- Abnormal placentation (i.e. placenta previa)
- Rupture of amniotic membranes
- Active preterm labor with cervical dilation > 6 cm
- Exposed amniotic membranes
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- Vaginal bleeding > 10 cc
- Frank chorioamnionitis
- Fetal death
- Fetal anomaly incompatible with life
- Severe fetal growth restriction (EFW < 5%)
- Uterine anomalies (i.e. bicornuate uterus, uterine didelphys)
- Mature fetal lung studies
- Maternal cardiac arrhythmias
- HIV, Hepatitis C, Hepatitis B
- History of herpes simplex virus (HSV)
- A permanent cardiac pacemaker
- A fetal cardiac arrhythmia
- Contraindication for tocolysis e.g. premature rupture of the amniotic membranes allowing for ascending intrauterine infection with group B streptococcus or GBS (beta hemolytic streptococcus, S. agalactiae) or other micro-organisms.
- IV or po narcotic pain medication < 12 hours prior to admission (regional anesthesia, long acting oral maintenance opiates i.e. methadone, Suboxone, Subutex not included in exclusion criteria)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electrical Inhibition (EI): A Preliminary Study to Prevent the Uterine Contractions of Human Preterm Labor and Preterm Birth
The purpose of this study is to explore a new method to stop preterm uterine contractions using an electrical device. The device, an "electrical pacemaker for the uterus," has been approved by the Food and Drug Administration (FDA) for clinical research in pregnant women. The purpose of this study is to evaluate the feasibility and safety of the device. The investigators hypothesize that human preterm uterine contractions can be safely and objectively inhibited with a weak electrical current provided by an electrical inhibition (EI)/uterine pacemaker device, and that this effect relates to the timing and length of EI exposure.
Read the detailed description
The purpose of this study is to determine the effectiveness of a new method of preventing the human preterm uterine contractions of labor during electrical monitoring. The objective is to test a method for the inhibition of human preterm uterine contractions with an electrical pacemaker, electrical inhibition (EI). The study will investigate EI associated changes in preterm uterine contraction frequency as monitored by objective uterine tocodynamometry and adjunct electromyography (EMG) and electrohysterogram (EHG). The endpoint is the statistically significant EI induced decrease in the gold standard tocodynamometric monitored preterm uterine contraction frequency. The adjunct EMG and EHG monitoring provides valuable adjunct data about the electrical activity of the preterm uterine contractions and the effect of EI on this activity.
The investigators hypothesize that human preterm uterine contractions can be safely and objectively inhibited with a weak electrical current provided by an electrical inhibition (EI)/uterine pacemaker device. This effect can be assessed by the use of a non-invasive tocodynamometer. It has been previously been shown that the frequency of contractions during preterm labor can be lowered by EI applied by the use of an intravaginal catheter carrying electrodes similar to a cardiac pacemaker (Karsdon et al). The investigators hypothesize that this effect relates to the timing and length of EI exposure.
- Being tested
- Electrical Uterine Pacemaker
- Medical subject headings
- Obstetric Labor, Premature, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Uterine PacemakerDevice
The catheter is placed under ultrasound guidance into the posterior vaginal fornix next to the external cervical os. The electrode connectors are attached to the EI device. Activating the EI device involves: 1) turning the current pulse duration rotary dial clockwise to the desired setting; this is an important setting and should be set at 20ms; 2) turning the current frequency rotary dial clockwise to the desired setting; 3) turn on the EI device on with the on/off toggle switch; 4) SLOWLY turning the current strength rotary dial clockwise to the desired setting, at this time the red light should be flashing. Usually 5-10mA of current is sufficient, but 20 mA is a maximum. Based on the tocometer recordings the least amount of EI current is given to inhibit the uterine contractions.
| Study group | Role | What they receive |
|---|---|---|
| 60 Minute Study | Experimental | After a 20-minute pre-intervention control period the electrical inhibition will be used intermittently, only when there is monitored contraction, during the 20-minute intervention study period. At the end of the intervention period there will be a 20-minute post-intervention control period. The FHR patterns, tocogram, EMG and EHG, and fECG recordings will be compared to before and after the use of the electrical uterine pacemaker device. Receives: Device: Electrical Uterine Pacemaker |
| 80 Minute Study | Experimental | After a 20-minute pre-intervention control period the electrical inhibition will be used intermittently, only when there is monitored contraction, during the 40-minute intervention study period. At the end of the intervention period there will be a 20-minute post-intervention control period. The FHR patterns, tocogram, EMG and EHG, and fECG recordings will be compared to before and after the use of the electrical uterine pacemaker device. Receives: Device: Electrical Uterine Pacemaker |
| 120 Minute Study | Experimental | After a 20-minute pre-intervention control period the electrical inhibition will be used intermittently, only when there is monitored contraction, during the 80-minute intervention study period. At the end of the intervention period there will be a 20-minute post-intervention control period. The FHR patterns, tocogram, EMG and EHG, and fECG recordings will be compared to before and after the use of the electrical uterine pacemaker device. Receives: Device: Electrical Uterine Pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine contraction frequency during labor as measured by external uterine tocodynamometric monitoring
Measured: Change from 20, 40, and 80 minutes
Secondary outcomes (6)
FHR pattern as measured by the maternal-fetal monitor
Measured: Change from 60 and 120 minutes
EMG monitoring as measured by LaborView Device
Measured: Change from 60 and 120 minutes
EHG monitoring as measured by LaborView Device
Measured: Change from 60 and 120 minutes
fECG monitoring as measured by LaborView Device
Measured: Change from 60 and 120 minutes
Maternal pain medication administration
Measured: Before and after use of electrical uterine pacemaker, assessed up to 120 minutes
Maternal heart rate
Measured: Change from 60 and 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study start1 Mar 2017
- Primary completion21 Jan 2026 (estimated)
- Study completion21 Jan 2026 (estimated)
Why it stopped: PI change
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 Preterm LaborStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- e-Bio Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Karsdon, MD, Study chair, New York University Lagone Medical CenterJohn Smulian, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983240
- Sponsor's protocol ID
- IRB201601699 - A
- Other IDs
- OCR26522, E-BIO CORP
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2016
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Karsdon J, El Daouk M, Huang WM, Ashmead GG. Electrical pacemaker as a safe and feasible method for decreasing the uterine contractions of human preterm labor. J Perinat Med. 2012 Nov;40(6):697-700. doi: 10.1515/jpm-2012-0136.
PubMed 23089601
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Inhibition (EI): A Preliminary Study to Prevent the Uterine Contractions of Human Preterm Labor and Preterm Birth
- ClinicalTrials.gov ID
- NCT02983240
- Acronym / sponsor ID
- IRB201601699 - A
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: PI change
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- e-Bio CorpIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 21 Jan 2026 (estimated)
- Study completion
- 21 Jan 2026 (estimated)
- First posted
- 6 Dec 2016 (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 purpose of this study is to explore a new method to stop preterm uterine contractions using an electrical device. The device, an "electrical pacemaker for the uterus," has been approved by the Food and Drug Administration (FDA) for clinical research in pregnant women. The purpose of this study is to evaluate the feasibility and safety of the device. The investigators hypothesize that human preterm uterine contractions can be safely and objectively inhibited with a weak electrical current provided by an electrical inhibition (EI)/uterine pacemaker device, and that this effect relates to the timing and length of EI exposure.
Detailed description
The purpose of this study is to determine the effectiveness of a new method of preventing the human preterm uterine contractions of labor during electrical monitoring. The objective is to test a method for the inhibition of human preterm uterine contractions with an electrical pacemaker, electrical inhibition (EI). The study will investigate EI associated changes in preterm uterine contraction frequency as monitored by objective uterine tocodynamometry and adjunct electromyography (EMG) and electrohysterogram (EHG). The endpoint is the statistically significant EI induced decrease in the gold standard tocodynamometric monitored preterm uterine contraction frequency. The adjunct EMG and EHG monitoring provides valuable adjunct data about the electrical activity of the preterm uterine contractions and the effect of EI on this activity.
The investigators hypothesize that human preterm uterine contractions can be safely and objectively inhibited with a weak electrical current provided by an electrical inhibition (EI)/uterine pacemaker device. This effect can be assessed by the use of a non-invasive tocodynamometer. It has been previously been shown that the frequency of contractions during preterm labor can be lowered by EI applied by the use of an intravaginal catheter carrying electrodes similar to a cardiac pacemaker (Karsdon et al). The investigators hypothesize that this effect relates to the timing and length of EI exposure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 60 Minute Study | Experimental | Device: Electrical Uterine PacemakerAfter a 20-minute pre-intervention control period the electrical inhibition will be used intermittently, only when there is monitored contraction, during the 20-minute intervention study period. At the end of the intervention period there will be a 20-minute post-intervention control period. The FHR patterns, tocogram, EMG and EHG, and fECG recordings will be compared to before and after the use of the electrical uterine pacemaker device. |
| 80 Minute Study | Experimental | Device: Electrical Uterine PacemakerAfter a 20-minute pre-intervention control period the electrical inhibition will be used intermittently, only when there is monitored contraction, during the 40-minute intervention study period. At the end of the intervention period there will be a 20-minute post-intervention control period. The FHR patterns, tocogram, EMG and EHG, and fECG recordings will be compared to before and after the use of the electrical uterine pacemaker device. |
| 120 Minute Study | Experimental | Device: Electrical Uterine PacemakerAfter a 20-minute pre-intervention control period the electrical inhibition will be used intermittently, only when there is monitored contraction, during the 80-minute intervention study period. At the end of the intervention period there will be a 20-minute post-intervention control period. The FHR patterns, tocogram, EMG and EHG, and fECG recordings will be compared to before and after the use of the electrical uterine pacemaker device. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Wong-Baker pain score ≤ 6
- Pregnancy Depression Scale score < 16
- Informed consent form signed and dated by patient
- Be willing and able to comply with study requirements
- Be between 18-50 years of age
Key exclusion criteria (20 listed)
- Severe preeclampsia
- Severe abruption placenta
- Abnormal placentation (i.e. placenta previa)
- Rupture of amniotic membranes
- Active preterm labor with cervical dilation > 6 cm
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 Uterine PacemakerThe catheter is placed under ultrasound guidance into the posterior vaginal fornix next to the external cervical os. The electrode connectors are attached to the EI device. Activating the EI device involves: 1) turning the current pulse duration rotary dial clockwise to the desired setting; this is an important setting and should be set at 20ms; 2) turning the current frequency rotary dial clockwise to the desired setting; 3) turn on the EI device on with the on/off toggle switch; 4) SLOWLY turning the current strength rotary dial clockwise to the desired setting, at this time the red light should be flashing. Usually 5-10mA of current is sufficient, but 20 mA is a maximum. Based on the tocometer recordings the least amount of EI current is given to inhibit the uterine contractions. | Device | 120 Minute Study, 60 Minute Study, 80 Minute Study |
Primary outcome
Uterine contraction frequency during labor as measured by external uterine tocodynamometric monitoring
Time frame: Change from 20, 40, and 80 minutes
6 secondary outcomes
FHR pattern as measured by the maternal-fetal monitor
Time frame: Change from 60 and 120 minutes
EMG monitoring as measured by LaborView Device
Time frame: Change from 60 and 120 minutes
EHG monitoring as measured by LaborView Device
Time frame: Change from 60 and 120 minutes
fECG monitoring as measured by LaborView Device
Time frame: Change from 60 and 120 minutes
Maternal pain medication administration
Time frame: Before and after use of electrical uterine pacemaker, assessed up to 120 minutes
Maternal heart rate
Time frame: Change from 60 and 120 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Background: PubMed 23089601Karsdon J, El Daouk M, Huang WM, Ashmead GG. Electrical pacemaker as a safe and feasible method for decreasing the uterine contractions of human preterm labor. J Perinat Med. 2012 Nov;40(6):697-700. doi: 10.1515/jpm-2012-0136.
- Individual participant dataSharing planned: No
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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.
Jeffrey Karsdon, MD study chair
New York University Lagone Medical Center
John Smulian, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Uterine Pacemaker in people with Preterm Labor and PreTerm Birth, run by e-Bio Corp 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 15 inclusion and 20 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: paused, as of the sponsor's last update on 4 Dec 2024. 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.
Are results available for this study?
Results are not available in the source record.
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?
Uterine contraction frequency during labor as measured by external uterine tocodynamometric monitoring (time frame: Change from 20, 40, and 80 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 NCT02983240, 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 4 Dec 2024.