About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Parallel
Treatments tested in this trial
visual biofeedback through trans-perineal ultrasound
BehavioralTrans-perineal ultrasound will be used to provide visual biofeedback during the active 2nd stage of labour, this for ten consecutive uterine contractions / pushing efforts
Treatment groups
Trial outcomes
Primary outcomes
Maternal childbirth satisfaction
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
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).
Secondary outcomes
Delivery mode
Spontaneous vaginal vs. operative delivery (vacuum and/or forceps delivery or 2nd stage caesarean section).
Urinary incontinence
The presence and severity of urinary incontinence will be assessed twice: once around 12 weeks postpartum, and once additionally 6-12 months postpartum. The incidence and severity of urinary incontinence will be self-reported, using the standardized and validated International Consultation on Incontinence Questionnaire - Short Form questionnaire for urinary incontinence. Total scores range from 0/21-21/21, with higher scores indicating worser symptoms.
Anal incontinence
The presence and severity of anal incontinence will be assessed twice: once around 12 weeks postpartum, and once additionally 6-12 months postpartum. The incidence and severity of anal incontinence will be self-reported, using the standardized and validated St. Marks Incontinence Score. Total scores range from 0/24-24/24, with higher scores indicating worser symptoms.
Prolapse symptoms
The presence and severity of prolapse symptoms will be assessed twice: once around 12 weeks postpartum, and once additionally 6-12 months postpartum. The incidence and severity of prolapse symptoms will be self-reported, using the standardized and validated Pelvic Organ Prolapse Distress Index for symptoms of pelvic organ prolapse. Total scores range from 0/24-24/24, with higher scores indicating worser symptoms.
Sponsors and contacts
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