Clinical trial NCT06847308: Visual Biofeedback Through Transperineal Ultrasound During the Expulsive Phase of Labour to Improve Maternal Childbirth Satisfaction
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 488
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Maternal childbirth satisfaction
timeFrame: From enrollment to two days after delivery
measure: Vaginal birth-induced perineal trauma
timeFrame: Assessment immediately after childbirth (delivery of the baby)
Secondary outcomes:
measure: Delivery mode
timeFrame: From enrollment to the end of the delivery
measure: Urinary incontinence
timeFrame: From enrollment to the end of follow-up at 1 year postpartum
measure: Anal incontinence
timeFrame: From enrollment to the end of follow-up at 1 year postpartum
measure: Prolapse symptoms
timeFrame: From enrollment to the end of follow-up at 1 year postpartum
measure: Sexual function
timeFrame: From enrollment to the end of follow-up at 1 year postpartum
measure: Sexual function
timeFrame: From enrollment to the end of follow-up at 1 year postpartum
measure: Duration of the total second stage
timeFrame: 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.
measure: Duration of the active total second stage
timeFrame: 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.
measure: Delta-AoP
timeFrame: 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).
measure: Delta LAM
timeFrame: 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).
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: The University Hospitals Leuven
state: Vlaams-Braband
Study officials:
affiliation: University Hospitals Leuven / KU Leuven
name: Jute Richter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals Leuven / KU Leuven
name: Jan Deprest, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: