Electrical Inhibition of Human Preterm Contractions

NCT ID: NCT02983240

Last Updated: 2024-12-04

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2026-01-21

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.

Conditions

Preterm Labor; PreTerm Birth; Preterm Labor With Delivery Nos

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

60 Minute Study

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.

Group Type: EXPERIMENTAL

Electrical Uterine Pacemaker

Intervention Type: DEVICE

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.

80 Minute Study

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.

Group Type: EXPERIMENTAL

Electrical Uterine Pacemaker

Intervention Type: DEVICE

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.

120 Minute Study

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.

Group Type: EXPERIMENTAL

Electrical Uterine Pacemaker

Intervention Type: DEVICE

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.

Interventions

Electrical Uterine Pacemaker

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

e-Bio Corp

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Karsdon, MD

Role: STUDY_CHAIR

New York University Lagone Medical Center

John Smulian, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23089601 (View on PubMed)

Other Identifiers

OCR26522

Identifier Type: OTHER

Identifier Source: secondary_id

E-BIO CORP

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201601699 - A

Identifier Type: -

Identifier Source: org_study_id