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

NCT06847308 | Not Yet Recruiting

• 2 other identifiers: S682761S49923N
• Study Type: interventional
• Target: 488
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Labor Stage, Second; Labor and Delivery; Satisfaction With Care; Childbirth

Keywords

2nd stage of labour; visual biofeedback; maternal childbirth satisfaction; obstetrics; ultrasound; trans-perineal ultrasound

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Delivery mode

  From enrollment to the end of the delivery

• Urinary incontinence

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

• Anal incontinence

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

• Prolapse symptoms

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

• Sexual function

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

Study Arms (2)

Intervention - VB with TPUS

ACTIVE COMPARATOR

Use of ultrasound for visual biofeedback

Behavioral: visual biofeedback through trans-perineal ultrasound

Control Group - standard of care

NO INTERVENTION

Control group that will receive standard of care

Interventions

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

Intervention - VB with TPUS

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).
• Linguistic barriers - not able to give written informed consent in Dutch.
• Severe visual impairment (sufficient to the receipt/comprehension of visual biofeedback).

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

The University Hospitals Leuven

Leuven, Vlaams-Braband, 3000, Belgium

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jute Richter, MD, PhD

  University Hospitals Leuven / KU Leuven

  PRINCIPAL INVESTIGATOR

• Jan Deprest, MD, PhD

  University Hospitals Leuven / KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bram Packet, MD

CONTACT

+3216348824; bram.packet@kuleuven.be

Kobe Haenen, MD

CONTACT

+3216348824; kobe.haenen@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Trial statistician
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: February 26, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 3, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)