Visual Biofeedback (VB) Through Trans-Perineal Ultrasound (TPU) During the Active 2nd Stage of Labour to Improve Maternal Childbirth Satisfaction: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 488
- 试验地点
- 1
- 主要终点
- Maternal childbirth satisfaction
研究概览
简要总结
Childbirth is generally regarded as a positive life-changing experience. Up to 44% of women may however experience this as a traumatic event, with 3% suffering from post-traumatic stress disorder after childbirth. The aetiology of a traumatic childbirth experience is a complex interplay between pre-birth, intra-partum and postnatal factors. Feelings of loss of control, lack of interaction with the obstetric caregiver and lack of emotional or practical support during labour are important contributing factors. This trial aims to investigate the effect of providing Visual Biofeedback (VB) through Trans-Perineal Ultrasound (TPU) during the active 2nd stage of labour on maternal childbirth satisfaction. The hypothesis is that the intervention will improve patient-caregiver communication and enhance parturient women's sense of control and empowerment, ultimately improving the birth experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Trial statistician
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •(all must be met):
- •Voluntary written informed consent of the participant.
- •Term (37-42w) singleton gestations.
- •Vaginally nulliparous (no previous vaginal birth > 20 weeks of gestation).
- •Fetus in cephalic presentation, without any major congenital or chromosomal anomalies.
- •Admitted to the delivery unit in labour, regardless of the onset (spontaneous or induced).
- •Epidural analgesia in situ.
- •Non-pathological CTG at the time of recruitment (2015 FIGO classification).
排除标准
- •(if one or more is present):
- •Significant psychiatric comorbidity (psychiatric follow-up during pregnancy, or active (psycho-pharmacological) treatment).
- •History of severe PFDs/surgery (or any other condition affecting pelvic floor function/anatomy, besides pregnancy and delivery).
- •Significant neurological disease e.g., spinal injury, multiple sclerosis, diabetic neuropathy, etc.
- •Significant connective tissue disorders (e.g., Ehlers-Danlos syndrome).
- •Severe active maternal (pregnancy-related) comorbidity: non-exhaustive e.g., severe hypertensive disorder, significant antepartum haemorrhage, sepsis, thromboembolism, severe pre-existing cardiac/respiratory/neurological disease, etc. Well-controlled comorbidities will not be considered exclusion criteria (non-exhaustive e.g., well-controlled (gestational) diabetes, hypertensive disorders of pregnancy, PROM without signs of intra-amniotic infection, etc.).
- •Linguistic barriers - not able to give written informed consent in Dutch.
- •Severe visual impairment (sufficient to the receipt/comprehension of visual biofeedback).
研究组 & 干预措施
Intervention - VB with TPUS
Use of ultrasound for visual biofeedback
干预措施: visual biofeedback through trans-perineal ultrasound (Behavioral)
Control Group - standard of care
Control group that will receive standard of care
结局指标
主要结局
Maternal childbirth satisfaction
时间窗: From enrollment to two days after delivery
Maternal childbirth satisfaction will be assessed using the Birth Satisfaction Scale revised (BSS-R) questionnaire. The total score ranges from 0/40 to 40/40, with lower scores indicating worser satisfaction.
Vaginal birth-induced perineal trauma
时间窗: Assessment immediately after childbirth (delivery of the baby)
Assessed immediately after delivery through clinical examination (inspection and palpation) of the perineal region and grading of any injury according to the Sultan classification (intact - firs degree tear: vaginal mucosa/perineal skin - second degree tear: perineal muscles - third degree tear: external and/or internal anal sphincter - fourth degree tear: anorectal mucosa).
次要结局
- Sexual function(From enrollment to the end of follow-up at 1 year postpartum)
- Delivery mode(From enrollment to the end of the delivery)
- Urinary incontinence(From enrollment to the end of follow-up at 1 year postpartum)
- Anal incontinence(From enrollment to the end of follow-up at 1 year postpartum)
- Prolapse symptoms(From enrollment to the end of follow-up at 1 year postpartum)
- Duration of the total second stage(From the onset of full cervical dilatation (= onset of the second stage) until childbirth (= delivery of the baby), estimated to range between 0-180 minutes.)
- Duration of the active total second stage(From the onset of active maternal pushing efforts (= onset of the active second stage) and childbirth (= delivery of the baby), estimated to range between 0-120 minutes.)
- Delta-AoP(During the active second stage of labour, from the first to the 10th consecutive pushing effort, estimated interval 20 minutes (4-5 contractions/10 minutes).)
- Delta LAM(During the active second stage of labour, from the first to the 10th consecutive pushing effort, estimated interval 20 minutes (4-5 contractions/10 minutes).)