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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

488 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2028-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Labor Stage, Second Labor and Delivery Satisfaction With Care Childbirth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Trial statistician

Study Groups

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Intervention - VB with TPUS

Use of ultrasound for visual biofeedback

Group Type ACTIVE_COMPARATOR

visual biofeedback through trans-perineal ultrasound

Intervention Type 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

Control Group - standard of care

Control group that will receive standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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visual biofeedback through trans-perineal ultrasound

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 Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

* 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).

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No