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

Universitaire Ziekenhuizen KU Leuven

Status: Not yet enrolling

Conditions: Labor Stage, Second; Childbirth; Satisfaction with Care; Labor and Delivery

Treatments: Behavioral: visual biofeedback through trans-perineal ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT06847308

1S49923N (Other Grant/Funding Number)

S68276

Details and patient eligibility

About

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.

Enrollment: 488 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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488 participants in 2 patient groups

Intervention - VB with TPUS

Active Comparator group

Description:

Use of ultrasound for visual biofeedback

Treatment:

Behavioral: visual biofeedback through trans-perineal ultrasound

Control Group - standard of care

No Intervention group

Description:

Control group that will receive standard of care