Electrical Inhibition (EI): A Preliminary Study to Prevent the Uterine Contractions of Human Preterm Labor and Preterm Birth
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Uterine contraction frequency during labor as measured by external uterine tocodynamometric monitoring
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Uterine contraction frequency during labor as measured by external uterine tocodynamometric monitoring
时间窗: Change from 20, 40, and 80 minutes
次要结局
- 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)