Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childbirth | — | UNRESOLVED | — |
| Labor and Delivery | — | UNRESOLVED | — |
| Labor Stage, Second | — | UNRESOLVED | — |
| Satisfaction With Care | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| visual biofeedback through trans-perineal ultrasound | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intervention - VB with TPUS
- description
- Use of ultrasound for visual biofeedback
- interventionNames
- Behavioral: visual biofeedback through trans-perineal ultrasound
- type
- NO_INTERVENTION
- label
- Control Group - standard of care
- description
- Control group that will receive standard of care
Primary outcomes (2)
- measure
- Maternal childbirth satisfaction
- timeFrame
- From enrollment to two days after delivery
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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).
References
Publications (1)
- DERIVEDPacket B, Laenen A, Haenen K, Williams H, Deprest J, Richter J. Visual Biofeedback (VB) through Trans-Perineal Ultrasound (TPU) during the active second stage of labor to improve maternal childbirth satisfaction: protocol of a randomized controlled trial. BMC Pregnancy Childbirth. 2026 Mar 18;26(1):461. doi: 10.1186/s12884-026-08854-3. PMID 41845237