Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management During Artificial Induction of Labor by Cervical Ripening.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 132
- 主要终点
- Cervical dilation at analgesia initiation or delivery without epidural analgesia
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Fever at the time of inclusion
- •Participant under legal protection (guardianship or curatorship)
- •Inability to understand the French language
结局指标
主要结局
Cervical dilation at analgesia initiation or delivery without epidural analgesia
时间窗: 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.
次要结局
- Recall of pain during cervical ripening (numeric rating scale)(Week 8 postpartum)
- 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)
- Pain intensity during labor induction(Day 2 postpartum)
- Postpartum psychological status(Day 2 postpartum)
- Postpartum psychological status(Week 8 postpartum)
- Maternal satisfaction at 8 weeks postpartum(numeric rating scale)(Week 8 postpartum)
研究者
HOT Noémie
midwife
Poissy-Saint Germain Hospital