Visual Biofeedback Through Transperineal Ultrasound During the Expulsive Phase of Labour to Improve Maternal Childbirth Satisfaction (RCT:VB-TPU)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Labor and Delivery; Labor Stage, Second; Childbirth; Satisfaction with Care
• Intervention / Treatment: Behavioral: visual biofeedback through trans-perineal ultrasound

• Study Type: Interventional
• Enrollment (Estimated): 488
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bram Packet, MD; Phone Number: +3216348824; Email: bram.packet@kuleuven.be
• Study Contact Backup: Name: Kobe Haenen, MD; Phone Number: +3216348824; Email: kobe.haenen@kuleuven.be

Study Locations

• Belgium
  • Vlaams-Braband
    • Leuven, Vlaams-Braband, Belgium, 3000
      • The University Hospitals Leuven
      • Contact: Jute Richter, MD, PhD; Phone Number: +3216342288; Email: jute.richter@uzleuven.be
      • Contact: Jan Deprest, MD, PhD; Phone Number: +3216344211; Email: jan.deprest@uzleuven.be
      • Contact: Kobe Haenen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

INCLUSION criteria (all must be met):

1. Voluntary written informed consent of the participant.
2. Term (37-42w) singleton gestations.
3. Vaginally nulliparous (no previous vaginal birth > 20 weeks of gestation).
4. Fetus in cephalic presentation, without any major congenital or chromosomal anomalies.
5. Admitted to the delivery unit in labour, regardless of the onset (spontaneous or induced).
6. Epidural analgesia in situ.
7. 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention - VB with TPUS; Use of ultrasound for visual biofeedback	Behavioral: 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
No Intervention: Control Group - standard of care; Control group that will receive standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to two days after delivery
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).	Assessment immediately after childbirth (delivery of the baby)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delivery mode	Spontaneous vaginal vs. operative delivery (vacuum and/or forceps delivery or 2nd stage caesarean section).	From enrollment to the end of the delivery
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.	From enrollment to the end of follow-up at 1 year postpartum
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.	From enrollment to the end of follow-up at 1 year postpartum
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.	From enrollment to the end of follow-up at 1 year postpartum
Sexual function	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.	From enrollment to the end of follow-up at 1 year postpartum
Sexual function	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.	From enrollment to the end of follow-up at 1 year postpartum
Duration of the total second stage	The period between full cervical dilatation and delivery of the baby.	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	The period between the onset of active maternal pushing efforts (= active second stage) and delivery of the baby.	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	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.	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	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.	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).

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Jute Richter, MD, PhD, University Hospitals Leuven / KU Leuven; Principal Investigator: Jan Deprest, MD, PhD, University Hospitals Leuven / KU Leuven

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): March 3, 2027
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: February 20, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: ultrasound; obstetrics; 2nd stage of labour; visual biofeedback; maternal childbirth satisfaction; trans-perineal ultrasound
• Other Study ID Numbers: S68276; 1S49923N (Other Grant/Funding Number: Research Council Flanders (FWO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Privacy and ethical restrictions

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No