NCT06847308Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 26 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry): Not yet recruiting
Study type: Interventional
Enrollment: 488 (estimated)
First submitted: 5 Dec 2024
Start date: 1 Mar 2025
Primary completion date: 3 Mar 2027
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
NCT number: NCT06847308

What you commit to

Study type: Interventional
Planned participants: 488
From 1 Mar 2025 to the primary completion date, 3 Mar 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

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.).
Severe visual impairment (sufficient to the receipt/comprehension of visual biofeedback).

Other

Linguistic barriers - not able to give written informed consent in Dutch.

Who the study is looking for

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).

Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
The University Hospitals Leuven Coordinator of this site? Confirm its status	Leuven	Belgium	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.