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Electrical Inhibition of Human Preterm Contractions

Primary Purpose

Preterm Labor, PreTerm Birth, Preterm Labor With Delivery Nos

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Electrical Uterine Pacemaker

About this trial

This is an interventional treatment trial for Preterm Labor

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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 34 weeks pregnant with a singleton gestation
Cervical dilation of ≤ 6 cm
Normal spontaneous vaginal delivery (NSVD) expected.
Be in preterm labor, as defined by the American College of Obstetricians and Gynecologists and the American Academy of Pediatrics, as follows:
Persistent uterine contractions (4 every 20 minutes, or 8 every 60 minutes)
And any one or more of the following:
Documented cervical change
1cm cervical dilatation and progressing
> 80% cervical effacement
Be admitted to Labor and Delivery with the diagnosis of preterm labor or preterm contractions

Exclusion Criteria:

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
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)

Sites / Locations

University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

60 Minute Study

80 Minute Study

120 Minute Study

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Uterine contraction frequency during labor as measured by external uterine tocodynamometric monitoring

Secondary Outcome Measures

FHR pattern as measured by the maternal-fetal monitor

EMG monitoring as measured by LaborView Device

EHG monitoring as measured by LaborView Device

fECG monitoring as measured by LaborView Device

Maternal pain medication administration

Maternal heart rate

Full Information

NCT ID

NCT02983240

First Posted

December 2, 2016

Last Updated

December 8, 2022

Sponsor

e-Bio Corp

1. Study Identification

Unique Protocol Identification Number

NCT02983240

Brief Title

Electrical Inhibition of Human Preterm Contractions

Official Title

Electrical Inhibition (EI): A Preliminary Study to Prevent the Uterine Contractions of Human Preterm Labor and Preterm Birth

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2017 (Actual)

Primary Completion Date

January 21, 2023 (Anticipated)

Study Completion Date

January 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

e-Bio Corp

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Preterm Labor, PreTerm Birth, Preterm Labor With Delivery Nos

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

60 Minute Study

Arm Type

Experimental

Arm Description

Arm Title

80 Minute Study

Arm Type

Experimental

Arm Description

Arm Title

120 Minute Study

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Electrical Uterine Pacemaker

Intervention Description

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.

Primary Outcome Measure Information:

Title

Uterine contraction frequency during labor as measured by external uterine tocodynamometric monitoring

Time Frame

Change from 20, 40, and 80 minutes

Secondary Outcome Measure Information:

Title

FHR pattern as measured by the maternal-fetal monitor

Time Frame

Change from 60 and 120 minutes

Title

EMG monitoring as measured by LaborView Device

Time Frame

Change from 60 and 120 minutes

Title

EHG monitoring as measured by LaborView Device

Time Frame

Change from 60 and 120 minutes

Title

fECG monitoring as measured by LaborView Device

Time Frame

Change from 60 and 120 minutes

Title

Maternal pain medication administration

Time Frame

Before and after use of electrical uterine pacemaker, assessed up to 120 minutes

Title

Maternal heart rate

Time Frame

Change from 60 and 120 minutes

Other Pre-specified Outcome Measures:

Title

Adverse events

Time Frame

Before and after use of electrical uterine pacemaker, assessed up to 120 minutes

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 Exclusion Criteria: 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 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

John Smulian, MD

Phone

352-273-7580

jsmulian@ufl.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey Karsdon, MD

Organizational Affiliation

New York University Lagone Medical Center

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

John Smulian, MD

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

John Smulian, MD

Phone

352-273-7580

jsmulian@ufl.edu

First Name & Middle Initial & Last Name & Degree

Jeffrey Karsdon, MD

First Name & Middle Initial & Last Name & Degree

Fred Naftolin, MD

First Name & Middle Initial & Last Name & Degree

John Smulian, MD

First Name & Middle Initial & Last Name & Degree

Lauren Silva, MD

First Name & Middle Initial & Last Name & Degree

Erica Smith, MD

First Name & Middle Initial & Last Name & Degree

Marcella Rodriguez, MD

First Name & Middle Initial & Last Name & Degree

Tony Wen, MD

First Name & Middle Initial & Last Name & Degree

Samuel Wu, PHD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23089601

Citation

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.

Results Reference

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Electrical Inhibition of Human Preterm Contractions

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