PreTerm Birth Clinical Trial
Official title:
Electrical Inhibition (EI): A Preliminary Study to Prevent the Uterine Contractions of Human Preterm Labor and Preterm Birth
Verified date | December 2022 |
Source | e-Bio Corp |
Contact | John Smulian, MD |
Phone | 352-273-7580 |
jsmulian[@]ufl.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 110 |
Est. completion date | January 21, 2023 |
Est. primary completion date | January 21, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
e-Bio Corp |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse events | Before and after use of electrical uterine pacemaker, assessed up to 120 minutes | ||
Primary | Uterine contraction frequency during labor as measured by external uterine tocodynamometric monitoring | Change from 20, 40, and 80 minutes | ||
Secondary | FHR pattern as measured by the maternal-fetal monitor | Change from 60 and 120 minutes | ||
Secondary | EMG monitoring as measured by LaborView Device | Change from 60 and 120 minutes | ||
Secondary | EHG monitoring as measured by LaborView Device | Change from 60 and 120 minutes | ||
Secondary | fECG monitoring as measured by LaborView Device | Change from 60 and 120 minutes | ||
Secondary | Maternal pain medication administration | Before and after use of electrical uterine pacemaker, assessed up to 120 minutes | ||
Secondary | Maternal heart rate | Change from 60 and 120 minutes |
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