Medical Device Pilot Study on the Safety and Feasibility of the INGA Sensor System for Fetal and Uterine Monitoring During Cervical Ripening With the INGA Balloon Catheter
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Proportion of successful sensor measurements
研究概览
简要总结
The goal of this clinical trial is to learn about the safety and performance of the INGA Sensor System when used with the INGA balloon catheter during cervical ripening for labor induction in pregnant individuals at term. Cervical ripening is a process used to prepare the cervix for labor.
The main questions it aims to answer are:
- Is the INGA Sensor System safe to use during cervical ripening with the INGA balloon catheter?
- How well does the sensor system measure uterine contractions and fetal heart rate during cervical ripening?
- How does the use of the INGA balloon catheter affect cervical ripening and the time from induction to delivery?
- How do participants and healthcare professionals evaluate the usability of the catheter and sensor system?
All participants in this study will receive the INGA balloon catheter with the attached sensor system. There is no comparison group.
Participants will:
- Undergo routine assessments before labor induction, including medical history review, cervical examination, blood pressure and heart rate measurement, and fetal heart rate monitoring
- Have the INGA balloon catheter placed in the cervix by a trained physician
- Have a small sensor device attached to the external end of the catheter
- Undergo standard fetal heart rate monitoring after placement
- Keep the catheter and sensor in place until the catheter is expelled naturally or for up to 24 hours
- Continue labor induction and delivery according to standard hospital practice
- Complete a questionnaire about comfort and usability
- Allow collection of information about labor, delivery, and newborn outcomes from medical records
Participation lasts from signing informed consent until hospital discharge.
详细描述
This is a prospective, single-arm, early feasibility clinical trial designed to evaluate the safety, performance, and usability of the INGA Sensor System when used together with the INGA cervical ripening catheter during induction of labor in pregnant individuals at term. Approximately 120 participants are planned to be enrolled.
The primary objective of the study is to evaluate the performance of the INGA Sensor System in providing clinically interpretable data on fetal wellbeing and induction progress during cervical ripening. A successful measurement is defined as the sensor providing interpretable signal data for at least 10 consecutive minutes.
Secondary objectives include evaluation of device usability, technical performance, maternal and neonatal safety, and obstetric outcomes such as change in Bishop score, induction-to-delivery interval, and mode of delivery.
Participation lasts from signing informed consent until hospital discharge following delivery.
Screening phase
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 其他
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 18 Years 至 56 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- Pregnant women aged ≥18 and ≤56 years
- An unripe cervix, see below
- Planned induction of labor by mechanical balloon catheter method
- Gestational age at the time of the study ≥ 37 weeks
- Singleton pregnancy
- Cephalic presentation
- The subject understands the study information and signs the informed consent
排除标准
- Preterm induction of labor (<37 weeks of gestation)
- Clinical active vaginal or uterine infection
- Abnormal cardiotocography (CTG) at inclusion
- Spontaneous rupture of membranes at inclusion
- Clinically significant vaginal bleeding with need of hospitalization in the third trimester
- Maternal HIV, hepatitis C, or hepatitis B
- Condition of the fetus or mother requiring immediate delivery
- Presence of eclampsia
- Severe Preeclampsia (Blood pressure ≥160/110 and any of the following: HELLP (Hemolysis, Elevated Liver enzymes, and Low Platelet count <100 × 10 9/L syndrome), progressive renal insufficiency, pulmonary edema)
- Severe fetal growth restriction (FGR, growth < -2 SD/<10th percentile)
- Estimated fetal weight ≥ 2SD or ≥ 95th percentile
- Breech or transverse fetal position
- Multiple pregnancy
- Vasa previa or placenta previa
- Uterine scar (including previous caesarean section)
- Umbilical cord prolapse
- Bishop score ≥6 on cervical assessment prior to labor induction
- Reduced amniotic fluid volume (deepest vertical pocket <30 mm)
- Receiving epidural anesthesia prior to catheter insertion
- Refusal to participate in the study and/or insufficient language skills to understand the study information and/or consent form
研究组 & 干预措施
INGA Sensor
Participants in this single study arm will undergo cervical ripening using the INGA balloon catheter with the attached INGA sensor during labor induction. The catheter is inserted vaginally through the cervical canal so that the balloon tip is positioned between the amniotic membranes and the internal cervical os. The balloon is inflated with 50-75 mL of sterile saline and the external end is secured to the inner thigh. The INGA sensor is attached to the external portion of the catheter and records maternal and fetal data, such as heart rate and uterine contractions. Clinical monitoring is performed according to hospital guidelines. CTG monitoring is conducted for at least 60 minutes after placement. The sensor remains in place until catheter detachment or up to 24 hours.
干预措施: Cervical ripening, labor Induction, uterus and fetal monitoring (Device)
结局指标
主要结局
Proportion of successful sensor measurements
时间窗: During catheter and sensor placement, up to 24 hours
Proportion (%) of successful sensor measurements out of all measurement attempts. A successful measurement is defined as a sensor reading that provides clinically interpretable fetal heart rate and/or uterine contraction data for at least 10 consecutive minutes.
次要结局
- Health care professional's experience on the sensor usability(Periprocedurally (after catheter and sensor placement))
- Patient-reported assessment of pain(Periprocedurally)
- Patient-reported experience of the device use(Periprocedurally)
- Healthcare professionals' experience of catheter usability(Periprocedurally (after catheter and sensor placement))
- Adverse events and safety(Through study completion, an average of 4 days.)
- Percentage of monitoring time with valid continuous pressure signal from the INGA Sensor(During continuous monitoring from INGA catheter and INGA sensor placement until catheter expulsion and sensor removal, up to 24 hours)
- Device malfunctions(During catheter and sensor placement, up to 24 hours)
- Signal Interruptions(During continuous monitoring with the INGA Sensor, from sensor placement until sensor removal, up to 24 hours)
- Time required for setup and measurement(Periprocedurally, from the start of catheter placement to the initiation of successful sensor measurement, up to 120 minutes)
- Bishop score change(From catheter insertion to detachment, assessed up to 24 hours.)
- Placement success(Periprocedurally, at the time of catheter insertion, up to 30 minutes)
- Retention time of balloon catheter(From catheter insertion to detachment, 0-24 hours)
- Induction to delivery Interval(From balloon catheter placement to birth, 0-48 hours)
- Mode of delivery(From time of enrollment until delivery, assessed up to 7 days from enrollment)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07846111
- 其他研究编号
- CIV-EE-26-08-059575., 240023
日期
- 首次提交
- (28天前)
- 首次发布
- (昨天)
- 主要完成日期
- (4个月后)
- 研究完成日期
- (6个月后)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- UNDECIDED
- 是否有结果
- 否