Electrical Inhibition of Human Preterm Contractions

NCT02983240 | Suspended FDA Device

• 3 other identifiers: IRB201601699 - AOCR26522E-BIO CORP
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Labor; PreTerm Birth; Preterm Labor With Delivery Nos

Outcome Measures

Primary Outcomes (1)

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

  Change from 20, 40, and 80 minutes

Secondary Outcomes (6)

• FHR pattern as measured by the maternal-fetal monitor

  Change from 60 and 120 minutes

• EMG monitoring as measured by LaborView Device

  Change from 60 and 120 minutes

• EHG monitoring as measured by LaborView Device

  Change from 60 and 120 minutes

• fECG monitoring as measured by LaborView Device

  Change from 60 and 120 minutes

• Maternal pain medication administration

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

Other Outcomes (1)

• Adverse events

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

Study Arms (3)

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.

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.

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.

Device: Electrical Uterine Pacemaker

Interventions

Electrical Uterine Pacemaker 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; 60 Minute Study; 80 Minute Study

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• cm cervical dilatation and progressing
• \> 80% cervical effacement
• Be admitted to the maternity unit with the diagnosis of preterm labor or preterm contractions

You may not qualify if:

• 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

Sponsors & Collaborators

• e-Bio Corp: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

• 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.

  PMID: 23089601 BACKGROUND

MeSH Terms

Conditions

Obstetric Labor, Premature; Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Jeffrey Karsdon, MD

  New York University Lagone Medical Center

  STUDY CHAIR

• John Smulian, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 6, 2016
• Study Start: March 1, 2017
• Primary Completion: January 21, 2026
• Study Completion: January 21, 2026
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)