Electrical Inhibition of Human Preterm Contractions
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StatusAccepting Candidates
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Age18 Years - 50 Years
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SexesFemale
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Healthy VolunteersAccepts Healthy Volunteers
Objective
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.
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.
Details
Full study title | Electrical Inhibition (EI): A Preliminary Study to Prevent the Uterine Contractions of Human Preterm Labor and Preterm Birth |
Protocol number | OCR26522 |
ClinicalTrials.gov ID | NCT02983240 |
Phase | N/A |
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)
Lead researcher
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John C Smulian, MD, MPHMaternal and Fetal Medicine Specialist
Participate in a study
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Step1
Contact the research team
Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.
Primary contact
John Smulian -
Step2
Get screened to confirm eligibility
You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.
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Step3
Provide your consent to participate
If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.
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Step4
Participate
If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.