Pilot Study to Evaluate a Prototype Electronic Uterine Inhibitor to Prevent Preterm Contractions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Uterine Contractions
研究概览
简要总结
Use an electrical-inhibition (EI)/uterine pacemaker device similar to an electrical heart pacemaker to deliver a weak electrical current to the human uterus that will rapidly and safely inhibit the unwanted premature uterine contractions of preterm birth.
详细描述
The preterm birth rate in the United states has been stubbornly stuck at 10.5% or higher since the 1950's. The 2011 rate, 11.72%, is the most recent level available. That comes to about a half a million preterm births per year in the United States alone.
Premature birth and the attendant complications are among the greatest health problems in the world today and contribute to about 85% of all neonatal deaths, that is, deaths of infants from the time of birth until1 month old.
During the past ten years, there has been developed a novel method to effectively and objectively inhibit uterine contractility during the birthing process.
The method is nonpharmaceutical, and thus, avoids systemic side effects and has the potential to be noninvasive and easy to master.
This method uses an electrical intervention (EI)/uterine pacemaker device that will allow for rapid and reversible inhibition of preterm uterine contractions and preterm birth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pending preterm birth
- •vaginal birth
排除标准
- •disease disorders including but not limited to thyroid, liver disease, HIV, diabetes or drug addiction
- •using a permanent cardiac pacemaker
- •have malignancies that are currently being treated or recurrent
研究组 & 干预措施
Electrical Intervention
Electrical intervention (EI) is bipolar, constant-current (1-20 mA), square-wave pulses in 20% duty cycles. Women in preterm labor have an electrode placed vaginally; tocodynamometric contraction timing and fetal heart rate are monitored continuously. Successive 20-minute periods include pre-control period (C1); the EI period, in which a 10-second current burst is delivered at expected contraction times; and a post-EI control period (C2).
干预措施: Electrical Intervention (EI) (Device)
结局指标
主要结局
Uterine Contractions
时间窗: 20 minutes, 40 minutes, 60 minutes
The first 20 minutes are the control contraction period (C1). The second 20 minutes are the EI period, with a 10-second burst of current administered just prior to each expected contraction; expected contractions are determined by the timing of the C1 contractions and/or by the rise of the subjective tocodynamometer tracing above baseline levels. The third 20 minutes is the post-intervention control contraction period (C2).
Number of Newborn With Fetal Heart Arrhythmias
时间窗: 60 minutes
Number of newborn with fetal heart arrhythmias noted
次要结局
- Latency of Birth(Time until delivery, up to 4 weeks)
- Pain During the Birthing Process(Until birthing process is complete)
- Apgars Score(1 minute and 5 minute after childbirth)
- The Length of NICU Stay(up to one month)
- Gestational Age at Discharge(until after childbirth)