Induction of Labor by Cervical Ripening and Transcutaneous Electrical Nerve Stimulation (TENS)

NCT07494539 | Not Yet Recruiting

• 1 other identifier: 2026-A00012-47
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

labor pain; induction of labor; TENS

Outcome Measures

Primary Outcomes (1)

• Cervical dilation at analgesia initiation or delivery without epidural analgesia

  Composite endpoint defined by the occurrence of at least one of the following events: Cervical dilation ≥3 cm at the time of neuraxial analgesia initiation (epidural or spinal anesthesia), or Vaginal delivery without the use of epidural analgesia.

  At the time of neuraxial analgesia initiation or at delivery (for participants without epidural analgesia)

Secondary Outcomes (10)

• Duration of labor phases

  At delivery

• Mode of delivery

  At delivery.

• Epidural analgesia rate

  At delivery

• Analgesic treatments administered during cervical ripening

  At delivery

• Childbirth experience using the Questionnaire for Assessing the Childbirth Experience

  Day 2 postpartum

Study Arms (2)

Arm A - Experimental: TENS analgesia

EXPERIMENTAL

Participants receive transcutaneous electrical nerve stimulation (TENS) for pain management during cervical ripening for labor induction. The device is placed and its use explained by the midwife responsible for the induction. Standard analgesic treatments remain available if needed to complement pain management.

Device: Transcutaneous Electrical Nerve Stimulation (TENS); Other: Standard analgesic care

Arm B - Active Comparator: Standard analgesic care

ACTIVE COMPARATOR

Participants receive standard analgesic care during cervical ripening for labor induction. The midwife responsible for the induction offers usual analgesic treatments according to the participant's needs.

Other: Standard analgesic care

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

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.

Arm A - Experimental: TENS analgesia

Standard analgesic care OTHER

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.

Arm A - Experimental: TENS analgesia; Arm B - Active Comparator: Standard analgesic care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Participant under legal protection (guardianship or curatorship)
• Inability to understand the French language

Sponsors & Collaborators

• HOT Noémie: lead

MeSH Terms

Conditions

Labor Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: midwife

Model Details: Due to the nature of the intervention (use of a TENS device), participants and care providers cannot be blinded. Outcome assessment will be based on standardized pain scores reported by the participants.

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03