Labor Stage, SecondRCT:VB-TPUNCT06847308
Visual Biofeedback Through Transperineal Ultrasound During the Expulsive Phase of Labour to Improve Maternal Childbirth Satisfaction
A study testing visual biofeedback through trans-perineal ultrasound in people with Labor Stage, Second and Labor and Delivery, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Labor Stage, Second, Labor and Delivery, Satisfaction With Care
- What is being tested?
- visual biofeedback through trans-perineal ultrasound
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 488 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2025to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Voluntary written informed consent of the participant.
- Term (37-42w) singleton gestations.
- Vaginally nulliparous (no previous vaginal birth > 20 weeks of gestation).
- Fetus in cephalic presentation, without any major congenital or chromosomal anomalies.
- Admitted to the delivery unit in labour, regardless of the onset (spontaneous or induced).
- Epidural analgesia in situ.
- Non-pathological CTG at the time of recruitment (2015 FIGO classification).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
The University Hospitals Leuven
Leuven, Vlaams-Braband, 3000
Jute Richter, MD, PhD, +3216342288, jute.richter@uzleuven.be
Jan Deprest, MD, PhD, +3216344211, jan.deprest@uzleuven.be
About this study
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
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.
- Being tested
- visual biofeedback through trans-perineal ultrasound
- Keywords
- 2nd stage of labour, visual biofeedback, maternal childbirth satisfaction, obstetrics, ultrasound, trans-perineal ultrasound
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visual biofeedback through trans-perineal ultrasoundBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention - VB with TPUS | Active comparator | Use of ultrasound for visual biofeedback Receives: Behavioral: visual biofeedback through trans-perineal ultrasound |
| Control Group - standard of care | No intervention | Control group that will receive standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Assessment immediately after childbirth (delivery of the baby)
Secondary outcomes (10)
Delivery mode
Spontaneous vaginal vs. operative delivery (vacuum and/or forceps delivery or 2nd stage caesarean section).
Measured: 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.
Measured: From enrollment to the end of follow-up at 1 year postpartum
Anal incontinence
The presence and severity of anal incontinence will be assessed twice: once around 12 weeks postpartum, and once additionally 6-12 months postpartum. The incidence and severity of anal incontinence will be self-reported, using the standardized and validated St. Marks Incontinence Score. Total scores range from 0/24-24/24, with higher scores indicating worser symptoms.
Measured: From enrollment to the end of follow-up at 1 year postpartum
Prolapse symptoms
The presence and severity of prolapse symptoms will be assessed twice: once around 12 weeks postpartum, and once additionally 6-12 months postpartum. The incidence and severity of prolapse symptoms will be self-reported, using the standardized and validated Pelvic Organ Prolapse Distress Index for symptoms of pelvic organ prolapse. Total scores range from 0/24-24/24, with higher scores indicating worser symptoms.
Measured: From enrollment to the end of follow-up at 1 year postpartum
Sexual function
Sexual function will be assessed twice: once around 12 weeks postpartum, and once additionally 6-12 months postpartum. Sexual function will be self-reported, using the standardized and validated Female Sexual Function Index (19 items, range 2/36-36/36). Higher scores indicate more severe dysfunction.
Measured: From enrollment to the end of follow-up at 1 year postpartum
Sexual function
Sexual function will be assessed twice: once around 12 weeks postpartum, and once additionally 6-12 months postpartum. Sexual function will be self-reported, using the standardized and validated Female Sexual Distress Scale-Revised questionnaire (13 items, range 0/52-52/52). Higher scores indicate more severe dysfunction.
Measured: From enrollment to the end of follow-up at 1 year postpartum
Duration of the total second stage
The period between full cervical dilatation and delivery of the baby.
Measured: 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.
Duration of the active total second stage
The period between the onset of active maternal pushing efforts (= active second stage) and delivery of the baby.
Measured: 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.
Delta-AoP
Differences in the angle of progression (AoP, in degrees) at rest and maximal Valsalva during the active 2nd stage (i.e., active maternal pushing efforts), measured by transperineal ultrasound during the first and 10th consecutive pushing effort.
Measured: 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).
Delta LAM
Differences in the anteroposterior diameter of the puborectalis part of the levator ani muscle (LAM) at rest and maximal Valsalva during the active 2nd stage (= active maternal pushing efforts), measured by transperineal ultrasound during the first and 10th consecutive pushing effort.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion3 Mar 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor Stage, SecondStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 488 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jute Richter, MD, PhD, Principal investigator, University Hospitals Leuven / KU LeuvenJan Deprest, MD, PhD, Principal investigator, University Hospitals Leuven / KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847308
- Sponsor's protocol ID
- S68276
- Other IDs
- 1S49923N
- Acronym
- RCT:VB-TPU
- Status last verified
- Feb 2025
- First submitted
- 5 Dec 2024
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Privacy and ethical restrictions
Publications
Packet 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.
PubMed 41845237
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06847308
- Acronym / sponsor ID
- RCT:VB-TPU / S68276
- Keywords
- 2nd stage of labour, visual biofeedback, maternal childbirth satisfaction, obstetrics, ultrasound, trans-perineal ultrasound
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 488 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 3 Mar 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention - VB with TPUS | Active comparator | Behavioral: visual biofeedback through trans-perineal ultrasoundUse of ultrasound for visual biofeedback |
| Control Group - standard of care | No intervention | –Control group that will receive standard of care |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntary written informed consent of the participant.
- Term (37-42w) singleton gestations.
- Vaginally nulliparous (no previous vaginal birth > 20 weeks of gestation).
- Fetus in cephalic presentation, without any major congenital or chromosomal anomalies.
- Admitted to the delivery unit in labour, regardless of the onset (spontaneous or induced).
Key exclusion criteria (7 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| visual biofeedback through trans-perineal ultrasoundTrans-perineal ultrasound will be used to provide visual biofeedback during the active 2nd stage of labour, this for ten consecutive uterine contractions / pushing efforts | Behavioural | Intervention - VB with TPUS |
Primary outcome
Maternal childbirth satisfaction
Time frame: From enrollment to two days after delivery
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.
Vaginal birth-induced perineal trauma
Time frame: Assessment immediately after childbirth (delivery of the baby)
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).
10 secondary outcomes
Delivery mode
Time frame: From enrollment to the end of the delivery
Urinary incontinence
Time frame: From enrollment to the end of follow-up at 1 year postpartum
Anal incontinence
Time frame: From enrollment to the end of follow-up at 1 year postpartum
Prolapse symptoms
Time frame: From enrollment to the end of follow-up at 1 year postpartum
Sexual function
Time frame: From enrollment to the end of follow-up at 1 year postpartum
Sexual function
Time frame: From enrollment to the end of follow-up at 1 year postpartum
Duration of the total second stage
Time frame: 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.
Duration of the active total second stage
Time frame: 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.
Delta-AoP
Time frame: 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).
Delta LAM
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Derived from this study: PubMed 41845237Packet 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.
- Individual participant dataSharing planned: No. Privacy and ethical restrictions
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jute Richter, MD, PhD principal investigator
University Hospitals Leuven / KU Leuven
Jan Deprest, MD, PhD principal investigator
University Hospitals Leuven / KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing visual biofeedback through trans-perineal ultrasound in people with Labor Stage, Second and Labor and Delivery, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bram Packet, MD (+3216348824, bram.packet@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal childbirth satisfaction (time frame: From enrollment to two days after delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06847308, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.