Induction of Labor by Cervical Ripening and Transcutaneous Electrical Nerve Stimulation (TENS)
NCT07494539 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132
Last updated 2026-03-27
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.
Conditions
- Labor Pain
- Induction of Labor
Interventions
- DEVICE
-
Transcutaneous Electrical Nerve Stimulation (TENS)
A TENS device is applied during cervical ripening for labor induction to provide non-pharmacological analgesia. The electrodes are placed on the participant's lower back by the midwife responsible for the induction, and the participant receives instructions on how to adjust the stimulation intensity according to her comfort. The device can be used throughout the cervical ripening period. Standard analgesic treatments remain available if needed according to usual clinical practice.
- OTHER
-
Standard analgesic care
Participants receive usual analgesic care during cervical ripening for labor induction according to routine clinical practice. Pharmacological or non-pharmacological analgesic treatments may be offered by the midwife depending on the participant's needs.
Sponsors & Collaborators
-
HOT Noémie
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-01
- Primary Completion
- 2028-04-01
- Completion
- 2028-04-01
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