Pilot Study to Evaluate A Prototype Electronic Uterine Inhibitor to Prevent Preterm Contractions
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Contraction frequency
研究概览
简要总结
The objective is to test a novel paradigm for the inhibition of human preterm uterine contractions.
The study hypothesis is that human preterm contractions can be safely inhibited with a weak electrical current provided by an electrical inhibition/uterine pacemaker device.
Preterm birth is still a major problem. Current methods of preventing the uterine contractions of preterm are limited and associated with many side-effects affecting both the mother and baby. A reliable method of preventing preterm uterine contractions would be an important discovery. Such a method could eventually lead to a long-term goal of decreasing neonatal morbidity and mortality.
详细描述
The study design is a Pilot Study to confirm the safety of the uterine inhibitor/pacemaker and measure its effect on women experiencing preterm labor.
A total of 10 (ten) patients will be enrolled in this pilot study to confirm the methodology and safety of the device. Patients who meet the inclusion criteria and none of the exclusion criteria will be recruited for the study.
The study device (EI/uterine inhibitor/pacemaker) has been classified by FDA as an Investigational Device Exemption (IDE) number G080036, Class A device. The EI/uterine inhibitor/pacemaker device is FDA cleared for research of the prevention of the prevention of the human contractions of preterm birth.
This proposal is for an initial prospective FDA approved pilot study. After FDA evaluation of the pilot study findings and approval, the pilot study may lead eventually to a prospective randomized controlled clinical study.
Only adult women who are experiencing uterine contractions due to the birthing process are eligible.
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
- Health Services Research
- 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
- 否
入选标准
- •24 to 34 weeks pregnant
- •preterm labor
- •at least one contraction every 5 minutes for 30 minutes
- •> 3 cm cervical dilation; > 80% cervical effacement
- •Have received tocolysis therapy
- •Anticipate a normal spontaneous vaginal delivery (NSVD)
- •Be at least 18 years of age
- •Have signed a written informed consent document
- •Be willing and able to comply with study requirements
排除标准
- •Severe preeclampsia
- •Severe abruption placenta
- •Rupture of amnionic membranes
- •Frank chorioamnionitis
- •Fetal death
- •Fetal anomaly incompatible with life
- •Severe fetal growth restriction (estimated fetal weight <5%)
- •Mature fetal lung studies
- •Maternal cardiac arrythmias
- •A permanent cardiac pacemaker
- •A fetal cardiac arrhythmia
结局指标
主要结局
Contraction frequency
时间窗: 60 minutes
次要结局
- Preterm birth(24 hours)