Premature Birth Clinical Trial
Official title:
Electrical Inhibition (EI): A Preliminary Study To Prevent The Uterine Contractions Of Human Preterm Labor And Preterm Birth
An electrical-inhibition (EI) uterine pacemaker device similar to an electrical heart pacemaker delivers a weak electrical current to the human uterus during active preterm labor to rapidly and safely inhibit the unwanted premature uterine contractions and possibly a preterm birth.
Electrical intervention (EI) uses bipolar, constant-current (1-20 mA), square-wave pulses in
20% duty cycles. Women in active preterm labor have an electrode catheter placed into the
posterior fornix of the vaginal canal. The EI current is given up to 80 minutes while
monitoring tocodynamometric (toco) contractions and adjunct electrohysterographic (EHG)
activity while continuously monitoring maternal vital signs, fetal heart rate and
electrocardiogram (fECG). The study includes a pre-EI control period (C1); the EI period,
when a 10-second current burst is delivered only during a contraction; and a post-EI control
period (C2). The whole study will take a maximum of two hours.
The uterine toco contraction frequency and adjunct EHG electrical activity are analyzed for
changes caused by EI. Changes in maternal vital signs, fetal heart rate and fECG will
determine EI side-effects.
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