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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorUniversitaire Ziekenhuizen KU Leuven

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • visual biofeedback through trans-perineal ultrasound

    Behavioral

    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

Treatment groups

488 Participants
are divided into 2 treatment groups
Group A: Intervention - VB with TPUSActive comparator 1 intervention
Group B: Control Group - standard of careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to two days after delivery
2

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).

Time frame
Assessment immediately after childbirth (delivery of the baby)

Secondary outcomes

1

Delivery mode

Spontaneous vaginal vs. operative delivery (vacuum and/or forceps delivery or 2nd stage caesarean section).

Time frame
From enrollment to the end of the delivery
2

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.

Time frame
From enrollment to the end of follow-up at 1 year postpartum
3

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.

Time frame
From enrollment to the end of follow-up at 1 year postpartum
4

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.

Time frame
From enrollment to the end of follow-up at 1 year postpartum

Other outcomes

Sponsors and contacts

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