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| ID | Type | Description | Link |
|---|---|---|---|
| 1S49923N | Other Grant/Funding Number | Research Council Flanders (FWO) |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention - VB with TPUS | Active Comparator | Use of ultrasound for visual biofeedback |
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| Control Group - standard of care | No Intervention | Control group that will receive standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| visual biofeedback through trans-perineal ultrasound | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | Assessment immediately after childbirth (delivery of the baby) |
| Measure | Description | Time Frame |
|---|---|---|
| Delivery mode | Spontaneous vaginal vs. operative delivery (vacuum and/or forceps delivery or 2nd stage caesarean section). | 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. |
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INCLUSION criteria (all must be met):
EXCLUSION criteria (if one or more is present):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bram Packet, MD | Contact | +3216348824 | bram.packet@kuleuven.be | |
| Kobe Haenen, MD | Contact | +3216348824 | kobe.haenen@kuleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Jute Richter, MD, PhD | University Hospitals Leuven / KU Leuven | Principal Investigator |
| Jan Deprest, MD, PhD | University Hospitals Leuven / KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University Hospitals Leuven | Leuven | Vlaams-Braband | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41845237 | Derived | 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. |
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Privacy and ethical restrictions
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Trial statistician
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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