Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07494539

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Labor Pain Induction of Labor Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

Labor induction by cervical ripening is frequently performed in obstetric practice when continuation of pregnancy presents risks for the mother or fetus. Cervical ripening is commonly associated with painful uterine contractions that may lead to early use of pharmacological analgesia, including epidural analgesia.

Transcutaneous electrical nerve stimulation (TENS) is a non-invasive and non-pharmacological analgesic technique based on the delivery of low-voltage electrical stimulation through skin electrodes. TENS has been used for pain management in various medical contexts, including labor, but evidence regarding its effectiveness specifically during cervical ripening remains limited.

The DETENS study is a randomized, controlled, open-label, monocentric interventional study conducted at the Intercommunal Hospital Center of Poissy-Saint-Germain-en-Laye. A total of 132 pregnant women requiring labor induction by cervical ripening will be enrolled and randomized in a 1:1 ratio to either a TENS group or a control group receiving standard analgesic care.

Participants will be randomized when painful uterine contractions requiring analgesia occur during cervical ripening. In the experimental group, a TENS device will be placed and explained to the participant by the midwife responsible for the induction, while standard analgesic treatments remain available if needed. In the control group, participants will receive usual analgesic care according to routine clinical practice.

The primary outcome is a composite criterion defined by cervical dilation ≥3 cm at the time of neuraxial analgesia initiation or vaginal delivery without epidural analgesia. Secondary outcomes include duration of labor phases, mode of delivery, use of analgesic treatments, maternal childbirth experience, pain perception, maternal satisfaction, and postpartum psychological status assessed using the Edinburgh Postnatal Depression Scale during postpartum hospitalization and at 8 weeks postpartum.

The study will be conducted over a 24-month inclusion period with follow-up extending to 8 weeks postpartum

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Cervical dilation at analgesia initiation or delivery without epidural analgesia

    Time frame: At the time of neuraxial analgesia initiation or at delivery (for participants 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.

Secondary outcomes

  1. Duration of labor phases

    Time frame: At delivery

    Duration of the different phases of labor, including the latent phase, active phase, and second stage of labor.

  2. Mode of delivery

    Time frame: At delivery.

    Mode of delivery recorded as vaginal delivery (spontaneous or instrumental) or cesarean section.

  3. Epidural analgesia rate

    Time frame: At delivery

    Proportion of participants receiving epidural analgesia during labor.

  4. Analgesic treatments administered during cervical ripening

    Time frame: At delivery

    Type and frequency of pharmacological analgesic treatments administered during cervical ripening.

  5. Childbirth experience using the Questionnaire for Assessing the Childbirth Experience

    Time frame: Day 2 postpartum

    Maternal childbirth experience assessed using the Questionnaire for Assessing the Childbirth Experience (QACE), a 25-item self-reported questionnaire using a 4-point Likert scale. Items are scored from 1 to 4 and negatively worded items are reverse-coded. Higher scores indicate a more negative childbirth experience.

  6. Pain intensity during labor induction

    Time frame: Day 2 postpartum

    Pain intensity during labor induction (numeric rating scale) Pain intensity during the labor induction phase assessed using a numeric rating scale ranging from 0 to 10, with higher scores indicating greater pain intensity.

  7. Postpartum psychological status

    Time frame: Day 2 postpartum

    Maternal psychological status assessed using the Edinburgh Postnatal Depression Scale (EPDS), a self-reported questionnaire ranging from 0 to 30, with higher scores indicating more severe depressive symptoms.

  8. Postpartum psychological status

    Time frame: Week 8 postpartum

    Postpartum psychological status (Edinburgh Postnatal Depression Scale [EPDS]) Maternal psychological status assessed using the Edinburgh Postnatal Depression Scale (EPDS), a self-reported questionnaire ranging from 0 to 30, with higher scores indicating more severe depressive symptoms.

  9. Maternal satisfaction at 8 weeks postpartum(numeric rating scale)

    Time frame: Week 8 postpartum

    Maternal satisfaction regarding the cervical ripening and induction process assessed using a numeric rating scale ranging from 0 to 10, with higher scores indicating greater satisfaction.

  10. Recall of pain during cervical ripening (numeric rating scale)

    Time frame: Week 8 postpartum

    Maternal recall of pain perceived during cervical ripening assessed using a numeric rating scale ranging from 0 to 10, with higher scores indicating greater pain intensity, as recalled by the participant.

Sponsors and collaborators

Lead sponsor

HOT Noémie

Other

Registry information

Official study title

Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management During Artificial Induction of Labor by Cervical Ripening.

Acronym: DETENS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.