Electrical Inhibition of Human Preterm Contractions

Not Applicable

Suspended

• Conditions: Preterm Labor; Preterm Labor With Delivery Nos; PreTerm Birth
• Interventions: Device: Electrical Uterine Pacemaker

• Registration Number: NCT02983240
• Lead Sponsor: e-Bio Corp

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.

Study Timeline

• Study First Submitted: 2016-12-02
• Study First Submitted QC: 2016-12-05
• Study First Posted: 2016-12-06
• Study Start: 2017-03-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-01
• Last Update Posted: 2024-12-04
• Primary Completion: 2026-01-21
• Study Completion: 2026-01-21

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 110

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
120 Minute Study	Electrical Uterine Pacemaker	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.
80 Minute Study	Electrical Uterine Pacemaker	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.
60 Minute Study	Electrical Uterine Pacemaker	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.

Primary Outcome Measures

Name	Time	Method
Uterine contraction frequency during labor as measured by external uterine tocodynamometric monitoring	Change from 20, 40, and 80 minutes

Secondary Outcome Measures

Name	Time	Method
Maternal heart rate	Change from 60 and 120 minutes
EMG monitoring as measured by LaborView Device	Change from 60 and 120 minutes
FHR pattern as measured by the maternal-fetal monitor	Change from 60 and 120 minutes
EHG 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
fECG monitoring as measured by LaborView Device	Change from 60 and 120 minutes

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States