An Open, Parallel-group, Randomized, Early Feasibility Trial to Evaluate the Initial Safety and Performance of the INGA Catheter in Labor Induction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Bishop Score Change
研究概览
简要总结
This study investigates the safety and usability of the new INGA catheter for labor induction.
Labor induction is common, with about one in three births being induced. In this study, the INGA catheter will be compared to a currently used method. The INGA catheter is a single-balloon device that works similarly to a Foley catheter but is made from different materials. Feedback will be collected from both healthcare professionals and participating women.
详细描述
Screening Phase
Before any study-related procedures are initiated, participants will be asked to read and sign the informed consent form. Once consent is obtained, the following screening assessments will be performed to determine eligibility for participation:
- Confirmation of informed consent.
- Review of inclusion and exclusion criteria to ensure suitability for the study.
- Collection of medical and demographic information, including medical history, concurrent or previous medications, planned delivery date, gestational age, and indication for labor induction.
- Cervical assessment by palpation.
- Measurement of blood pressure and heart rate.
- Cardiotocography (CTG) monitoring of fetal heart rate and uterine contractions for a minimum of 30 minutes.
- Ultrasound examination within one week prior to induction, to evaluate fetal weight, well-being, and overall status.
If the screening assessments confirm that the participant meets all eligibility criteria, she will proceed to the study phase and receive the assigned study device.
Study Device and Randomization
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 score assessment (0-10-point scale)
- •Planned induction of labor by balloon catheter method
- •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 informed consent
排除标准
- •Preterm induction of labor (<37 weeks of gestation)
- •Abnormal Cardiotocography (CTG) at inclusion
- •Spontaneous rupture of membranes at inclusion
- •Clinically significant vaginal bleeding with a need of hospitalization in the third trimester
- •Clinical active vaginal or uterine infection
- •Maternal Human Immunodeficiency Virus (HIV), hepatitis C, or hepatitis B
- •Uterine scar (including previous cesarean section)
- •Condition requiring immediate delivery of the fetus or mother
- •Presence of eclampsia
- •Severe Preeclampsia [Blood pressure (BP)≥ 160/110 and any of the following: thrombocytopenia with platelet count <100 × 10e9/L, HELLP- syndrome ( Hemolysis, Elevated Liver enzymes and Low Platelets), progressive renal insufficiency, pulmonary edema ]
- •Severe fetal growth restriction (Fetal Growth Restriction (FGR) fetal growth <-2 SD/<10th percentile)
- •Estimated fetal weight ≥ 2 Standard Deviation /≥ 95th percentile
- •Reduced amniotic fluid volume (deepest vertical pocket <30 mill meter)
- •Breech or transverse fetal position
- •Multiple pregnancy
- •Vasa previa or placenta previa
- •Umbilical cord prolapses
- •Bishop score ≥6 on cervical assessment prior to labor induction
- •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
Currently used induction catheter
Insertion of the currently used induction balloon catheter through the cervical canal into the uterus is performed for labor induction. During a vaginal examination, the Investigator inserts the catheter so that the balloon tip lies between the amniotic membranes and the internal cervical os. The balloon is filled with 50-75 ml of sterile saline (NaCl) and secured to the upper thigh to maintain gentle traction. The catheter remains in place for up to 24 hours or until spontaneous expulsion. If not expelled, it is removed after 24 hours.
After expulsion or removal, cervical status and Bishop score are assessed. If Bishop ≥ 6, amniotomy and/or oxytocin induction are initiated within one hour. If Bishop < 6, further management follows
干预措施: Currently used single balloon catheter (Device)
INGA Catheter
Description: Insertion of the INGA balloon catheter (medical device) through the cervical canal into the uterus is performed for labor induction. During a vaginal examination, the Investigator inserts the catheter so that the balloon tip lies between the amniotic membranes and the internal cervical os. The balloon is filled with 50-75 ml of sterile saline (NaCl) and secured to the upper thigh to maintain gentle traction. The catheter remains in place for up to 24 hours or until spontaneous expulsion. If not expelled, it is removed after 24 hours. After expulsion or removal, cervical status and Bishop score are assessed. If Bishop ≥ 6, amniotomy and/or oxytocin induction are initiated within one hour. If Bishop < 6, further management follows
干预措施: INGA Catheter (Device)
结局指标
主要结局
Bishop Score Change
时间窗: From catheter insertion to detachment
Change in Bishop score (A scale from 1 to 10) during cervical ripening, with scores assessed before catheter insertion and after catheter detachment.
次要结局
- Mode of delivery(From enrolment to birth)
- Placement success(At catheter insertion)
- Retention time of balloon catheter(From catheter placement to detachment, 0-24 hours)
- Induction to delivery interval(rom the start of balloon catheter insertion until the birth of the neonate, 0-48 hours)
- Pain experience during catheter insertion and in-place time(Within 60 minutes from catheter insertion)
- Professional's experience of catheter insertion and usability(From catheter insertion to detachment)