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NCT Number: NCT06847308

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

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.

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Key information

Conditions

Labor Stage, Second Childbirth Labor and Delivery Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Satisfaction With Care

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Primary outcomes

  1. Maternal childbirth satisfaction

    Time frame: 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.

  2. Vaginal birth-induced perineal trauma

    Time frame: 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).

Secondary outcomes

  1. Delivery mode

    Time frame: From enrollment to the end of the delivery

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

  2. Urinary incontinence

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

    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.

  3. Anal incontinence

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

    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.

  4. Prolapse symptoms

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

    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.

  5. Sexual function

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

    Sexual function will be assessed twice: once around 12 weeks postpartum, and once additionally 6-12 months postpartum. Sexual function will be self-reported, using the standardized and validated Female Sexual Function Index (19 items, range 2/36-36/36). Higher scores indicate more severe dysfunction.

  6. Sexual function

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

    Sexual function will be assessed twice: once around 12 weeks postpartum, and once additionally 6-12 months postpartum. Sexual function will be self-reported, using the standardized and validated Female Sexual Distress Scale-Revised questionnaire (13 items, range 0/52-52/52). Higher scores indicate more severe dysfunction.

  7. Duration of the total second stage

    Time frame: 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.

    The period between full cervical dilatation and delivery of the baby.

  8. Duration of the active total second stage

    Time frame: 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.

    The period between the onset of active maternal pushing efforts (= active second stage) and delivery of the baby.

  9. Delta-AoP

    Time frame: 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).

    Differences in the angle of progression (AoP, in degrees) at rest and maximal Valsalva during the active 2nd stage (i.e., active maternal pushing efforts), measured by transperineal ultrasound during the first and 10th consecutive pushing effort.

  10. Delta LAM

    Time frame: 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).

    Differences in the anteroposterior diameter of the puborectalis part of the levator ani muscle (LAM) at rest and maximal Valsalva during the active 2nd stage (= active maternal pushing efforts), measured by transperineal ultrasound during the first and 10th consecutive pushing effort.

Study contacts

Contact information is provided by the study sponsor or research team.

Bram Packet, MD

CONTACT

[email protected]

+3216348824

Kobe Haenen, MD

CONTACT

[email protected]

+3216348824

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: RCT:VB-TPU

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Feb 26, 2025
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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