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New sensor aims to make labor induction safer and smarter

NCT ID NCT07432282

Symptom relief Sponsor: Aalto University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This study tests a new sensor system that monitors the baby's heart rate and the mother's contractions during labor induction. About 120 pregnant women will use the sensor along with a special balloon catheter to prepare the cervix. The goal is to see if the sensor is safe and works well, and to learn how it affects the labor process.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Expected to start

Aug 2026

An estimate. Start dates often move.

Finished

Aug 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 56 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 requiring immediate delivery of the fetus or mother * 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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Balloon catheter for labor induction Cervical ripening Cervical ripening and induction of labor Induction of birth

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