A Medical Device Pilot Study to Evaluate the Safety and Usability of the Inga Catheter in Labor Induction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 6
- 主要终点
- Bishop score
研究概览
简要总结
The goal of this clinical study is to evaluate a new mechanical balloon catheter (INGA) used to prepare the cervix for labor induction in pregnant women at term.
The study aims to assess the safety, usability, and performance of the INGA catheter when used for cervical ripening before labor. Researchers will also collect feedback from healthcare professionals and participants about the use of the device.
Participants are pregnant women at term with a single baby in a head-down position who meet the study eligibility criteria.
Participants will:
- have the INGA balloon catheter inserted as part of labor induction,
- receive standard clinical care according to hospital practice,
- provide information about their experience and outcomes related to the device.
The results of this study will help determine whether the INGA catheter is safe and suitable for use in cervical ripening during labor induction.
详细描述
This prospective, single-arm clinical investigation evaluates the safety, usability, performance, and preliminary efficacy of the INGA mechanical cervical ripening balloon catheter when used for induction of labor at term. The study is conducted as a medical device investigation in accordance with the Declaration of Helsinki, ICH-GCP principles, and applicable regulatory and ethical requirements. All participants provide written informed consent prior to participation. Mechanical cervical ripening is an established method for labor induction, particularly in women with an unfavorable cervix. Balloon catheters promote cervical ripening through direct mechanical dilation and stimulation of endogenous prostaglandin release, offering a non-pharmacological alternative to pharmacologic methods.
The INGA catheter is a single-use mechanical single-balloon device intended for placement between the fetal membranes and the internal cervical os during a vaginal examination. After insertion, the balloon is filled with sterile saline according to the device instructions for use and maintained under gentle traction. The device may remain in place for up to 24 hours or until spontaneous detachment. Cervical status is assessed prior to catheter insertion and following catheter detachment or removal, and further induction management, including amniotomy and/or oxytocin administration, is performed according to routine clinical practice. Outpatient cervical ripening may be permitted for selected participants based on predefined clinical criteria and local hospital practice.
The study enrolls approximately 30-50 pregnant women at ≥37 weeks of gestation with a singleton pregnancy in cephalic presentation and an unfavorable cervix (Bishop score ≤6) for whom induction of labor has been clinically indicated. Both nulliparous and multiparous women may participate. After providing written informed consent and confirmation of eligibility, participants undergo cervical ripening with the INGA catheter as part of standard induction care. The study does not include a comparison group.
The study collects clinical data during cervical ripening, labor, and delivery in order to characterize device performance in a real-world hospital setting. In addition to clinical outcomes, the investigation includes structured assessments of user experience. Participating women complete questionnaires regarding pain and overall experience related to catheter placement and retention. Healthcare professionals complete structured usability evaluations addressing ease of insertion, handling characteristics, and overall device performance.
Clinical data are collected during cervical ripening, labor, and delivery to characterize device performance in a real-world hospital setting. In addition to clinical outcomes, structured user-reported data are obtained. Participating women complete questionnaires addressing pain and overall experience during catheter placement and retention. Healthcare professionals complete structured evaluations of device usability, ease of insertion, handling characteristics, and overall performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 56 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women aged ≥18 and ≤56 years
- •An unripe cervix, ≤6 points according to the Bishop assessment (0-10 point scale)
- •Planned induction of labor by mechanical balloon catheter method
- •Examples of diagnoses as the basis for labor induction:
- •Post-term pregnancy (≥41 weeks of gestation)
- •Maternal request for labor induction
- •Gestational diabetes
- •Preeclampsia (with blood pressure <150/100)
- •Well-controlled hypertension
- •Cholestasis of pregnancy
- •Humanitarian or psychosocial reasons
- •Gestational age at the time of the study ≥ 37 weeks (gestational age confirmed by ultrasound before the 21st week of pregnancy)
- •Singleton pregnancy
- •Cephalic presentation
- •The subject understands the study information and signs the consent form
排除标准
- •Preterm induction of labor (<37 weeks of gestation)
- •Pathological CTG at inclusion
- •Spontaneous rupture of membranes at inclusion
- •Clinically significant vaginal bleeding with need of hospitalization in the third trimester
- •Clinically active vaginal or uterine infection
- •Maternal HIV, hepatitis C, or hepatitis B
- •Uterine scar (including previous cesarean section)
- •Condition of the fetus or mother requiring immediate delivery
- •Presence of eclampsia
- •Severe Pre-eclampsia (Blood pressure ≥160/110 and any of the following: low platelet count (<100 × 10 9/L), HELLP, progressive renal insufficiency, pulmonary edema)
- •Severe fetal growth restriction (FGR, fetal growth < -2 SD)
- •Estimated fetal weight ≥ 2SD or ≥ 95th percentile
- •Breech or transverse fetal position
- •Multiple pregnancy
- •Vasa previa or placenta previa
- •Umbilical cord prolapse
- •Maternal 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 catheter for cervical ripening
Participants in this arm will undergo cervical ripening using the INGA cervical ripening balloon catheter as part of labor induction. The catheter is inserted into the cervix and filled with saline according to the device instructions. The balloon may remain in place for up to 24 hours unless expelled spontaneously earlier. Cervical status is assessed before and after catheter use using the Bishop score. Participants will receive standard obstetric care throughout labor induction and labor. Data on device usability, insertion experience, pain, retention time, and delivery outcomes will be collected. Participants and healthcare professionals involved in the procedure will also provide feedback on catheter performance and usability.
干预措施: Cervical ripening, labor induction (Device)
结局指标
主要结局
Bishop score
时间窗: From catheter insertion to detachment
The change in Bishop score (on a scale from 0 to 10) during cervical ripening assessed prior to catheter insertion and after catheter detachment
次要结局
- Successful catheter placement (clinical assessment by investigator)(Periprocedural (at the time of catheter insertion))
- Retention time of the balloon catheter(From balloon catheter placement to catheter detachment (up to 24 hours))
- Induction to delivery interval(From balloon catheter insertion to delivery of the neonate (assessed up to 48 hours after induction initiation))
- Mode of delivery(From enrolment to birth)
- Patient-reported pain assessment 30 minutes after catheter insertion(Within 60 minutes after catheter insertion)
- Professionals' experience of insertion and catheter usability(Periprocedural (after catheter insertion))