Electrical Inhibition of Human Preterm Contractions
Preterm Labor, PreTerm Birth, Preterm Labor With Delivery Nos
About this trial
This is an interventional treatment trial for Preterm Labor
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 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
Experimental
Experimental
Experimental
60 Minute Study
80 Minute Study
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 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.