Visual Biofeedback Through Transperineal Ultrasound During the Expulsive Phase of Labour to Improve Maternal Childbirth Satisfaction

Официальное название

Visual Biofeedback (VB) Through Trans-Perineal Ultrasound (TPU) During the Active 2nd Stage of Labour to Improve Maternal Childbirth Satisfaction: a Randomised Controlled Trial

Обзор

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.

Вмешательства

• Поведенческое visual biofeedback through trans-perineal ultrasound
  Trans-perineal ultrasound will be used to provide visual biofeedback during the active 2nd stage of labour, this for ten consecutive uterine contractions / pushing efforts

Первичные конечные точки

• Maternal childbirth satisfaction [Срок оценки: From enrollment to two days after delivery]
• Vaginal birth-induced perineal trauma [Срок оценки: Assessment immediately after childbirth (delivery of the baby)]

Вторичные конечные точки (10)

• Delivery mode [Срок оценки: From enrollment to the end of the delivery]
• Urinary incontinence [Срок оценки: From enrollment to the end of follow-up at 1 year postpartum]
• Anal incontinence [Срок оценки: From enrollment to the end of follow-up at 1 year postpartum]
• Prolapse symptoms [Срок оценки: From enrollment to the end of follow-up at 1 year postpartum]
• Sexual function [Срок оценки: From enrollment to the end of follow-up at 1 year postpartum]
• Sexual function [Срок оценки: From enrollment to the end of follow-up at 1 year postpartum]
• Duration of the total second stage [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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).]

Критерии участия

INCLUSION criteria (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).

EXCLUSION criteria (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).

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

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Бельгия · 1 центр

• The University Hospitals Leuven — Leuven

Публикации

• Packet B, Laenen A, Haenen K, Williams H, Deprest J, Richter J. Visual Biofeedback (VB) through Trans-Perineal Ultrasound (TPU) during the active second stage of labor to improve maternal childbirth satisfaction: protocol of a randomized controlled trial. BMC Pregnancy Childbirth. 2026 Mar 18;26(1):461. doi: 10.1186/s12884-026-08854-3. PMID 41845237

Идентификаторы

NCT: NCT06847308 · S68276 · 1S49923N

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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