Safety and Feasibility of the INGA Sensor System for Fetal and Uterine Monitoring During Cervical Ripening (INGA-SENPe)
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
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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
Before any study-related procedures are initiated, participants will be asked to read and sign an informed consent form. Once consent has been obtained, the following screening assessments will be performed to determine eligibility:
- Confirmation of informed consent.
- Review of inclusion and exclusion criteria to confirm suitability for the study.
- Collection of medical and demographic data, including medical history, current or previous medications, planned time of delivery, gestational age, and indication for labor induction.
- Cervical assessment by palpation.
- Measurement of blood pressure and heart rate.
- Cardiotocography (CTG) to monitor fetal heart rate and uterine contractions for at least 30 minutes.
- Ultrasound examination within one week prior to labor induction to assess fetal weight, well-being, and general condition.
Participants who meet all eligibility criteria will proceed to the study phase.
The study follows the standard clinical process for balloon catheter-based cervical ripening, with the addition of the investigational sensor. After insertion of the INGA catheter, the study sensor will be attached to the external end of the catheter fixed to the thigh for the duration of catheter placement. The sensor records data that are not visible to the participant or healthcare professionals. Throughout the procedure, the investigator and hospital staff will closely monitor the induction process and ensure the safety and well-being of both the mother and fetus.
Study procedures
Participants will undergo the following procedures as part of the study:
- A trained physician will insert the INGA cervical ripening catheter vaginally through the cervical canal. The balloon will be inflated with sterile saline to secure placement and taped to the inner thigh according to standard practice. After catheter placement, the INGA Sensor will be attached to the external portion of the catheter.
- Fetal heart rate monitoring (CTG) will be performed both before catheter insertion (for a minimum of 30 minutes) and after insertion (for a minimum of 60 minutes). After that, the sensor remains in place and continues to record data until it is turned off. Subsequent CTG monitoring during labor induction is conducted in accordance with the hospitals or clinic's protocol and guidelines
- Cervical ripeness will be assessed before catheter insertion and again after catheter removal or spontaneous detachment.
- The catheter will remain in place until it detaches spontaneously or for a maximum of 24 hours.
- After catheter removal, the cervical status will be reassessed, and labor induction will continue according to the hospital's standard of care.
Throughout the induction process, maternal and fetal well-being will be closely monitored by clinical staff. All adverse events and device-related events will be recorded and evaluated.
Comprehensive data will be collected on:
- The course of pregnancy and the labor induction process.
- Delivery outcomes, including mode and duration of delivery.
- Maternal safety data, including any adverse events or complications.
- Newborn assessments
- After birth, the following assessments will be performed on the newborn:
- Birth weight and height.
- Apgar score at 5 minutes after birth.
- Clinical data related to neonatal diagnoses, treatments, or conditions.
The sensor data will be analyzed by the sponsor's research team.
Questionnaires
To evaluate user experience and device tolerability, the following questionnaires will be completed:
Participants will be asked to complete a short questionnaire assessing their overall comfort, well-being, and any discomfort or pain experienced during balloon catheter placement and use.
The physician who inserted the catheter will complete a usability questionnaire assessing the practicality, ease of use, and overall handling of the device.
Post-Treatment Phase The INGA catheter and sensor are used only during the induction process in this study. No additional study-specific visits are required after hospital discharge. Postpartum care will follow standard hospital practice.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Heidi Kruit, MD, PhD, Associate professor
- Número de telefone: +358504284685
- E-mail: heidi.kruit@aalto.fi
Estude backup de contato
- Nome: Alena Lokteva
- Número de telefone: +358413100927
- E-mail: alena@mdsfinland.com
Locais de estudo
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Tallinn, Estônia, 10614
- West-Tallinn Central Hospital Women's Clinic (AS Lääne-Tallinna Keskhaigla naistekliinik/Pelgulinna Sünnitusmaja)
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Contato:
- Ksenia Buts, MD
- Número de telefone: +372 666 5705
- E-mail: ksenia.buts@keskhaigla.ee
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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. |
INGA balloon catheter mounted sensor system will be used for cervical ripening during labor induction. The data on sensor usability, registration of fetal and maternal heart activity, fetal movements and uterine contractions will be obtained. The INGA catheter insertion experience, patient pain, retention time, and delivery outcomes, as well as feedback from both participants and healthcare professionals regarding device performance and usability will be collected. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Proportion of successful sensor measurements
Prazo: 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. |
During catheter and sensor placement, up to 24 hours
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Patient-reported assessment of pain
Prazo: Periprocedurally
|
Patient-reported assessment of pain collected prior to, at insertion and 30 minutes after catheter insertion using a structured questionnaire. Pain is assessed using a 0-10 Numeric Rating Scale (0 = no pain, 10 = worst possible pain; higher = greater pain) |
Periprocedurally
|
|
Patient-reported experience of the device use
Prazo: Periprocedurally
|
Composite patient experience on integrated catheter and sensor system usability, ease of placement, sensor attachment and stability, technical performance, impact on daily activities, and willingness to use in the future are assessed using Likert scales (1-5; higher = better). The multiple Likert scale measurements will be aggregated to arrive at one reported Likert scale value as the overall integrated catheter and sensor system experience. |
Periprocedurally
|
|
Healthcare professionals' experience of catheter usability
Prazo: Periprocedurally (after catheter and sensor placement)
|
Composite healthcare professional-reported assessment of catheter usability, collected immediately after catheter placement using a structured study-specific questionnaire. Assessments include: Ease of catheter placement; Likert Scale (1=very difficult, 5=very easy; higher scores indicate easier placement) Catheter usability; Likert Scale (1=poor, 5=excellent; higher scores indicate better usability), Balloon inflation; Likert Scale (1=poor, 5=excellent; higher scores indicate better usability). The multiple Likert scale measurements will be aggregated to arrive at one reported Likert scale value as the overall catheter usability. |
Periprocedurally (after catheter and sensor placement)
|
|
Health care professional's experience on the sensor usability
Prazo: Periprocedurally (after catheter and sensor placement)
|
Composite healthcare professional-reported assessment of sensor usability, collected immediately after the integrated sensor placement using a structured study-specific questionnaire. Assessments include: Sensor attachment; Likert Scale (1=poor, 5=excellent; higher scores indicate better performance), Sensor stability; Likert Scale (1=poor, 5=excellent; higher scores indicate better performance), Technical performance of the sensor; Likert Scale (1=poor, 5= excellent; higher scores indicate better performance), Impact on workflow; Likert Scale (1=strongly disagree, 5 = strongly agree; higher scores indicate greater agreement with the statement), Impact on patient comfort; Likert Scale (1=strongly disagree, 5 = strongly agree; higher scores indicate greater agreement with the statement). The multiple Likert scale measurements will be aggregated to arrive at one reported Likert scale value as the overall sensor usability. |
Periprocedurally (after catheter and sensor placement)
|
|
Adverse events and safety
Prazo: Through study completion, an average of 4 days.
|
Incidence and type of maternal and fetal adverse events occurring during device use and labor induction. All adverse events are recorded and assessed according to clinical criteria. Adverse events are collected from the start of labor induction until discharge from the hospital after delivery. |
Through study completion, an average of 4 days.
|
|
Percentage of monitoring time with valid continuous pressure signal from the INGA Sensor
Prazo: During continuous monitoring from INGA catheter and INGA sensor placement until catheter expulsion and sensor removal, up to 24 hours
|
Signal quality will be assessed from the continuous pressure signal recorded by the INGA Sensor. A valid signal is defined as pressure data meeting the predefined signal validity criteria specified for the INGA Sensor. The outcome will be calculated as the duration of valid continuous pressure signal divided by the total monitoring duration and multiplied by 100. Unit of Measure: Percentage of monitoring time |
During continuous monitoring from INGA catheter and INGA sensor placement until catheter expulsion and sensor removal, up to 24 hours
|
|
Device malfunctions
Prazo: During catheter and sensor placement, up to 24 hours
|
Number and type of device malfunctions occurring during catheter and sensor placement. Unit of Measure = count of malfunctions |
During catheter and sensor placement, up to 24 hours
|
|
Signal Interruptions
Prazo: During continuous monitoring with the INGA Sensor, from sensor placement until sensor removal, up to 24 hours
|
Number and cumulative temporal duration of INGA sensor pressure signal interruptions during the recordings. Unit of Measure: Number of interruption events and length of signal interruption periods in minutes. |
During continuous monitoring with the INGA Sensor, from sensor placement until sensor removal, up to 24 hours
|
|
Time required for setup and measurement
Prazo: Periprocedurally, from the start of catheter placement to the initiation of successful sensor measurement, up to 120 minutes
|
Time required for device setup and initiation of successful measurement |
Periprocedurally, from the start of catheter placement to the initiation of successful sensor measurement, up to 120 minutes
|
|
Bishop score change
Prazo: From catheter insertion to detachment, assessed up to 24 hours.
|
Change in cervical readiness measured by the Bishop Score, a 0-10 scale (0 = unfavorable cervix, 10 = fully favorable; higher scores indicate more favorable cervix), assessed prior to catheter insertion and after catheter detachment. |
From catheter insertion to detachment, assessed up to 24 hours.
|
|
Placement success
Prazo: Periprocedurally, at the time of catheter insertion, up to 30 minutes
|
Whether the catheter is placed successfully |
Periprocedurally, at the time of catheter insertion, up to 30 minutes
|
|
Retention time of balloon catheter
Prazo: From catheter insertion to detachment, 0-24 hours
|
Time the balloon catheter remains in the cervix for cervical ripening |
From catheter insertion to detachment, 0-24 hours
|
|
Induction to delivery Interval
Prazo: From balloon catheter placement to birth, 0-48 hours
|
Time from initiation of labor induction (balloon catheter placement) to the delivery of the neonate. This includes both the cervical ripening phase and active labor. The outcome will capture the total duration of the induction-to-delivery process |
From balloon catheter placement to birth, 0-48 hours
|
|
Mode of delivery
Prazo: From time of enrollment until delivery, assessed up to 7 days from enrollment
|
The type of delivery for the participant, categorized as vaginal delivery, instrumental vaginal delivery, or cesarean section |
From time of enrollment until delivery, assessed up to 7 days from enrollment
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Leena Rahkonen, MD, PhD, Associate professor, Aalto University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CIV-EE-26-08-059575.
- 240023 (Número de outro subsídio/financiamento: Jane and Aatos Erkko Foundation)
Plano para dados de participantes individuais (IPD)
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