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

N/ANot Yet RecruitingNCT06847308

Universitaire Ziekenhuizen KU Leuven488 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

488

Conditions

Labor Stage, Second Labor and Delivery Satisfaction With Care

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: Assessment immediately after childbirth (delivery of the baby)

Secondary Outcomes

Delivery mode

Spontaneous vaginal vs. operative delivery (vacuum and/or forceps delivery or 2nd stage caesarean section).

Time frame: 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.