Induction of Labor by Cervical Ripening and Transcutaneous Electrical Nerve Stimulation (TENS)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHOT Noémie
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Contraindication to labor induction by cervical ripening
Contraindication to epidural analgesia
Major fetal anomaly
Maternal hypertension or hypotension
Trial design
Design model
Parallel
Treatments tested in this trial
Transcutaneous Electrical Nerve Stimulation (TENS)
DeviceA 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 interventionParticipants 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.
Treatment groups
132 Participants
are divided into 2 treatment groupsGroup A: Arm A - Experimental: TENS analgesiaExperimental treatment 2 interventions
Group B: Arm B - Active Comparator: Standard analgesic careActive comparator 1 intervention
Trial outcomes
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.
Time frame
At the time of neuraxial analgesia initiation or at delivery (for participants without epidural analgesia)Secondary outcomes
1
Duration of labor phases
Duration of the different phases of labor, including the latent phase, active phase, and second stage of labor.
Time frame
At delivery2
Mode of delivery
Mode of delivery recorded as vaginal delivery (spontaneous or instrumental) or cesarean section.
Time frame
At delivery.3
Epidural analgesia rate
Proportion of participants receiving epidural analgesia during labor.
Time frame
At delivery4
Analgesic treatments administered during cervical ripening
Type and frequency of pharmacological analgesic treatments administered during cervical ripening.
Time frame
At deliveryLocations
Sponsors and contacts
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HOT Noémie
Lead sponsor
Poissy-Saint Germain Hospital
Sponsor institution
Source ClinicalTrials.gov
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