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

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

• Устройство 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.
• Другое 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.

Первичные конечные точки

• Cervical dilation at analgesia initiation or delivery without epidural analgesia [Срок оценки: At the time of neuraxial analgesia initiation or at delivery (for participants without epidural analgesia)]

Вторичные конечные точки (10)

• Duration of labor phases [Срок оценки: At delivery]
• Mode of delivery [Срок оценки: At delivery.]
• Epidural analgesia rate [Срок оценки: At delivery]
• Analgesic treatments administered during cervical ripening [Срок оценки: At delivery]
• Childbirth experience using the Questionnaire for Assessing the Childbirth Experience [Срок оценки: Day 2 postpartum]
• Pain intensity during labor induction [Срок оценки: Day 2 postpartum]
• Postpartum psychological status [Срок оценки: Day 2 postpartum]
• Postpartum psychological status [Срок оценки: Week 8 postpartum]
• Maternal satisfaction at 8 weeks postpartum(numeric rating scale) [Срок оценки: Week 8 postpartum]
• Recall of pain during cervical ripening (numeric rating scale) [Срок оценки: Week 8 postpartum]

Критерии участия

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.

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07494539 · 2026-A00012-47

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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