Labor PainDETENSNCT07494539
Induction of Labor by Cervical Ripening and Transcutaneous Electrical Nerve Stimulation (TENS)
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) and Standard analgesic care in people with Labor Pain and Induction of Labor, run by HOT Noémie.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labor Pain, Induction of Labor
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation (TENS) and Standard analgesic care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
About this study
Official title: Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management During Artificial Induction of Labor by Cervical Ripening.
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.
Read the detailed description
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
- Conditions
- Labor Pain, Induction of Labor
- Being tested
- Transcutaneous Electrical Nerve Stimulation (TENS), Standard analgesic care
- Keywords
- labor pain, induction of labor, TENS
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard analgesic care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of neuraxial analgesia initiation or at delivery (for participants without epidural analgesia)
Secondary outcomes (10)
Duration of labor phases
Duration of the different phases of labor, including the latent phase, active phase, and second stage of labor.
Measured: At delivery
Mode of delivery
Mode of delivery recorded as vaginal delivery (spontaneous or instrumental) or cesarean section.
Measured: At delivery.
Epidural analgesia rate
Proportion of participants receiving epidural analgesia during labor.
Measured: At delivery
Analgesic treatments administered during cervical ripening
Type and frequency of pharmacological analgesic treatments administered during cervical ripening.
Measured: At delivery
Childbirth experience using the Questionnaire for Assessing the Childbirth Experience
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.
Measured: Day 2 postpartum
Pain intensity during labor induction
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.
Measured: Day 2 postpartum
Postpartum psychological status
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.
Measured: Day 2 postpartum
Postpartum psychological status
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.
Measured: Week 8 postpartum
Maternal satisfaction at 8 weeks postpartum(numeric rating scale)
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.
Measured: Week 8 postpartum
Recall of pain during cervical ripening (numeric rating scale)
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.
Measured: Week 8 postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HOT Noémie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, HOT Noémie, Poissy-Saint Germain Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494539
- Sponsor's protocol ID
- 2026-A00012-47
- Acronym
- DETENS
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management During Artificial Induction of Labor by Cervical Ripening.
- ClinicalTrials.gov ID
- NCT07494539
- Acronym / sponsor ID
- DETENS / 2026-A00012-47
- Conditions
- Labor Pain, Induction of Labor
- Keywords
- labor pain, induction of labor, TENS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- HOT NoémieUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm A - Experimental: TENS analgesia | Experimental | Device: Transcutaneous Electrical Nerve Stimulation (TENS), Other: Standard analgesic careParticipants 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. |
| Arm B - Active Comparator: Standard analgesic care | Active comparator | Other: Standard analgesic careParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Arm A - Experimental: TENS analgesia |
| Standard analgesic careParticipants 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. | Other | Arm A - Experimental: TENS analgesia, Arm B - Active Comparator: Standard analgesic care |
Primary outcome
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.
10 secondary outcomes
Duration of labor phases
Time frame: At delivery
Mode of delivery
Time frame: At delivery.
Epidural analgesia rate
Time frame: At delivery
Analgesic treatments administered during cervical ripening
Time frame: At delivery
Childbirth experience using the Questionnaire for Assessing the Childbirth Experience
Time frame: Day 2 postpartum
Pain intensity during labor induction
Time frame: Day 2 postpartum
Postpartum psychological status
Time frame: Day 2 postpartum
Postpartum psychological status
Time frame: Week 8 postpartum
Maternal satisfaction at 8 weeks postpartum(numeric rating scale)
Time frame: Week 8 postpartum
Recall of pain during cervical ripening (numeric rating scale)
Time frame: Week 8 postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) and Standard analgesic care in people with Labor Pain and Induction of Labor, run by HOT Noémie.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.