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临床试验/NCT06135961
NCT06135961Unknown不适用

Implementation of Intrapartum Non-invasive Electrophysiological Monitoring

Maxima Medical Center2 个研究点 分布在 1 个国家目标入组 3,471 人开始时间: 2023年11月20日最近更新:
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适应症

试验速览

阶段
不适用
发起方
入组人数
3,471
试验地点
2
主要终点
The number of operative interventions during labor
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Conventional cardiotocography (CTG) has been used extensively for more than 50 years to monitor the fetal condition during labour, but since the rate of operative deliveries keeps rising, its ability to improve neonatal outcomes is unsatisfactory. A transabdominal non-invasive and wireless alternative which overcomes the shortcomings of conventional methods is electrophysiological CTG (eCTG) monitoring. In eCTG the fetal heart rate (FHR) is measured by fetal electrocardiography (NI-fECG) and uterine activity (UA) by electrohysterography (EHG). Both NI-fECG and EHG have been proven more accurate and reliable than conventional non-invasive methods and are less affected by maternal body mass index (BMI).

This study aims to evaluate the mode of delivery, maternal and perinatal outcomes, costs and patient and healthcare professionals perspectives on eCTG monitoring versus the conventional CTG during labour at term with a singleton fetus in cephalic position.

The eCTG provides a more accurate assessment of the fetus and the UA, compared to the conventional CTG. This allows for optimization of the contraction pattern during high-risk deliveries. We hypothesize that this will reduce the number of operative interventions and improves perinatal outcome. There are three reasons why an improvement in the contraction pattern by the eCTG can influence our outcomes:

  1. EHG can detect excessive UA more accurately. Increased UA is a major risk for fetal distress. In this case, stimulation with oxytocin should be reduced or stopped. More adequate interpretation of FHR, reduced tachysystole and reduced hypertonia is expected to result in fewer instrumented vaginal deliveries and a reduction of caesarean sections due to fetal distress.
  2. EHG can demonstrate unorganized UA that needs to be corrected with a higher dose of oxytocin to enhance contraction frequency and efficiency. This can result in a less exhausted uterine muscle, shorter time to delivery, less vacuum deliveries and caesarean sections due to failure of progress. A shorter time to delivery will also result in a reduction of infections and blood loss.
  3. Accurate registration of the relation between the contraction and decelerations of FHR, is expected to result in more reliable assessment of the fetal condition. This can result in fewer unnecessary operative deliveries and less unpredictable poor perinatal outcomes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
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
是

入选标准

  • •Minimal age of 18 years old
  • •Pregnant women with a gestational age between 37+0 and 42+0 weeks and days
  • •Indication for fetal monitoring during labour
  • •Singleton fetus in cephalic position
  • •Oral and written informed consent is obtained

排除标准

  • •Insufficient knowledge of Dutch or English language
  • •Women with a multiple pregnancy
  • •Fetal and/or maternal cardiac arrhythmias
  • •Contraindications to abdominal patch placement (dermatologic diseases of the abdomen precluding preparation of the abdomen with abrasive paper)
  • •Women connected to an external or implanted electrical stimulator, such as Transcutaneous Electro Neuro Stimulation (TENS) and pacemaker (because of disturbance of the electrophysiological signal)
  • •Women who take a bath for multiple times during delivery and/or who take a bath for > 1 hour during the first stage of labour and/or who take a bath in the second stage of labour. eCTG monitoring is impossible in bath because the Bluetooth signal is disturbed. In bath, monitoring will be performed by conventional CTG monitoring. However, it is possible to take a shower with eCTG monitoring
  • •Treatment plan (with intervention plan) already made before inclusion is completed.
  • •Women who were included in the study, but when circumstances before labour call for delivery of the baby by unplanned caesarean section.
  • •There is insufficient time for proper counselling
  • •Women admitted with a clinical diagnosis of sepsis with hypotension (i.e. septic shock).

结局指标

主要结局

The number of operative interventions during labor

时间窗: During delivery

cesarean section or instrumental vaginal delivery

次要结局

  • Perineal laceration (grade 1, 2, 3a, 3b, 3c, 4)(Directly after childbirth)
  • Patient satisfaction by questionnaires(2-6 hours after childbirth)
  • Duration of the second stage of labor in minutes(Start pushing until childbirth)
  • Neonatal mortality(After the seventh day but before the 28th day of life)
  • The number of neonates with Neonatal Respiratory Distress Syndrome (RDS)(childbirth - 28th day postpartum)
  • The number of neonates with Meconium Aspiration Syndrome (MAS)(childbirth - 28th day postpartum)
  • Maternal mortality(During pregnancy and childbirth or within 42 days of termination of pregnancy)
  • The number of mothers with an uterine rupture(childbirth until six weeks postpartum)
  • For eCTG monitoring: amount of signal loss in percentage of total duration during labour(During delivery)
  • Duration of the first stage of labor in minutes(0-10 cm dilation during labor)
  • The timing and reason of operative interventions during labor(During delivery)
  • The number of participants with analgesia for pain reduction: epidural or/and remifentanil(During delivery)
  • The number of participants with a mediolateral episiotomy and reason for the episiotomy(Directly after childbirth)
  • Number (percentage) and result of fetal blood sampling during the primary and secondary stages of labour(During delivery)
  • The number of neonates with hypoxic ischemic encephalopathy(childbirth - 28th day postpartum)
  • Reason for the admission to Neonatal Intensive Care Unit(childbirth - 28th day postpartum)
  • Perinatal mortality(During pregnancy up to seven completed days of life)
  • The number of neonates with the need for mechanical ventilation(childbirth - 72 hours after childbirth)
  • The number of neonates with Clinical early onset sepsis(childbirth - 28th day postpartum)
  • The number of neonates with a 5 minute Apgar score <7(5 minutes after childbirth)
  • The number of neonates with convulsions(childbirth - 28th day postpartum)
  • The number of neonates with Confirmed early onset sepsis(childbirth - 72 hours after childbirth)
  • The number of neonates with admission to Neonatal Intensive Care Unit(childbirth - 28th day postpartum)
  • Length of Admission to Neonatal Intensive Care Unit(childbirth - 28th day postpartum)
  • The number of neonates with a neonatal acidosis at birth(Directly after childbirth)
  • The number of mothers admitted to the Intensive Care Unit(childbirth until six weeks postpartum)
  • The number of mothers with a thromboembolic event(childbirth until six weeks postpartum)
  • The number of mothers with a postpartum anemia due to postpartum haemorrhage with requires red cell transfusion(childbirth until six weeks postpartum)
  • The number of mothers with a suspected or confirmed postpartum infection requiring antibiotics(childbirth until six weeks postpartum)
  • Professional satisfaction by questionnaire(1 year after the start of the study)
  • For eCTG monitoring: EHG pattern before and after labour analgesia and the possible association of EHG pattern with labour analgesia(During delivery)
  • The number of mothers with an obstetric haemorrhage(childbirth until 24 hours after childbirth)
  • Costs as a business case model until six weeks postpartum(Delivery until six weeks postpartum)
  • For eCTG monitoring: frequency of switch from Nemo Fetal Monitoring System to conventional CTG + reason, timing and success percentage of the switch(During delivery)
  • For eCTG monitoring: EHG pattern within the first 1.5 hours postpartum and the possible association with the amount of bloodloss, medication use and time to placental expulsion(First 1.5 hours postpartum)

研究者

发起方
Maxima Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Phebe Berben

Medical doctor, PhD Candidate, Coordinating Investigator NIEM-II study

Maxima Medical Center

研究点 (2)

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