Induction of Labor by Cervical Ripening and Transcutaneous Electrical Nerve Stimulation (TENS) (NCT07494539) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Induction of Labor by Cervical Ripening and Transcutaneous Electrical Nerve Stimulation (TENS)
132 participantsStarted 2026-04-01
Plain-language summary
This study aims to evaluate the effectiveness of transcutaneous electrical nerve stimulation (TENS) for pain management during labor induction by cervical ripening.
Labor induction is a common obstetric procedure and cervical ripening may be associated with painful uterine contractions. Non-pharmacological analgesic methods such as TENS could help improve pain management during this phase. However, evidence regarding its effectiveness in this context remains limited.
This randomized, controlled, open-label monocentric study will compare the use of TENS in addition to usual analgesic care versus usual analgesic care alone in pregnant women undergoing labor induction with cervical ripening. The primary objective is to assess whether TENS reduces the need for neuraxial analgesia or delays its use during labor.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Pregnant women requiring labor induction by cervical ripening at the Intercommunal Hospital Center of Poissy-Saint-Germain-en-Laye will be screened for eligibility according to the following criteria.
Inclusion Criteria:
* Pregnant women aged 18 years or older
* Gestational age ≥ 37 weeks of amenorrhea
* Indication for labor induction requiring cervical ripening
* Planned cervical ripening using oral misoprostol (Angusta)
* Singleton pregnancy
* Able to provide written informed consent
* Affiliated with or beneficiary of a social security system
Exclusion Criteria:
* Contraindication to labor induction by cervical ripening
* Contraindication to epidural analgesia
* Major fetal anomaly
* Maternal hypertension or hypotension
* Maternal pacemaker and/or cardiac rhythm disorders
* Presence of metallic prosthesis regardless of location
* Ongoing deep vein thrombosis or under treatment for thrombosis
* Epilepsy
* Fever at the time of inclusion
* Participant under legal protection (guardianship or curatorship)
* Inability to understand the French language
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cervical dilation at analgesia initiation or delivery without epidural analgesia
Timeframe: At the time of neuraxial analgesia initiation or at delivery (for participants without epidural analgesia)