Pregnancy RelatedNCT05258786
Pre-labor Ultrasound as a Visual Biofeedback Device for Maternal Pushing Education
A study testing Pre-labor ultrasound as a visual biofeedback device for maternal pushing education and pelvic floor training in people with Pregnancy Related and Delivery Complication, run by Ariel University at 1 site in Israel.
Trial summary
The study will observe the effect of antenatal biofeedback with transperineal and abdominal ultrasound applied by a pelvic floor physical therapist. The training will focus on pelvic floor training and maternal-coached pushing with ultrasound-based visual biofeedback. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Delivery Complication
- What is being tested?
- Pre-labor ultrasound as a visual biofeedback device for maternal pushing education and pelvic floor training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- 18 Feb 2022to 28 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- pregnant nullipara women with a low-risk pregnancy who are planned for vaginal delivery. The biofeedback will occur at 36-42 gestational weeks.
Who cannot join
- an inability to fill questionaries due to communication issues or cesarean section performed due to major obstetrical events.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-labor Ultrasound as a Visual Biofeedback Device for Maternal Pushing Education and Pelvic Floor Training - a Randomized Control Trial
The study will observe the effect of antenatal biofeedback with transperineal and abdominal ultrasound applied by a pelvic floor physical therapist. The training will focus on pelvic floor training and maternal-coached pushing with ultrasound-based visual biofeedback. The investigators aim to assess maternal and neonatal obstetrical outcomes, urinary and fecal incontinence, and maternal psychological effects.
Read the detailed description
Childbirth is a challenging process both emotionally and physically. The anxiety and anticipation accompanying pregnancy, labor, and delivery were reported to be relieved by pre-labor education, providing knowledge regarding the physiological process of labor to future parents.
Ultrasound examination enables the laboring women the opportunity to see fetal head movements in response to maternal pushing, and previous studies have revealed the physiological and psychological advantages of ultrasound-mediated intrapartum biofeedback during the second stage of labor.
Pre-labor sonographic maternal coaching has the advantage of a clean setting, avoiding the stressful, frequently hectic nature of labor and delivery wards, and may enable a more comprehensive implementation of the method, a structured training program, and better physical and psychological outcomes. All available literature regarding the application of intrapartum and pre-labor ultrasound refers to the examination performed by obstetricians.
The study will observe the effect of antenatal biofeedback with transperineal and abdominal ultrasound applied by a pelvic floor physical therapist. The training will focus on two aspects: pelvic floor training and maternal coached pushing - both with ultrasound-based visual biofeedback. The investigators aim to assess maternal and neonatal obstetrical outcomes, urinary and fecal incontinence, and maternal psychological outcomes.
- Conditions
- Pregnancy Related, Delivery Complication
- Being tested
- Pre-labor ultrasound as a visual biofeedback device for maternal pushing education and pelvic floor training
- Keywords
- pre-labor education, biofeedback, ultrasound, vaginal delivery, fear of childbirth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-labor ultrasound as a visual biofeedback device for maternal pushing education and pelvic floor trainingBehavioural
- Ultrasound examination with the screen turned to the provider will assess the bladder movements at rest and during contraction of the pelvic floor and fetal head descent at rest and during pushing.
- The provider will turn the screen to the patient and explain the anatomical landmarks: bladder, fetal head, birth canal direction.
- A repeat of the first stage (1) with the screen turned to the patient: the biofeedback process. Bladder displacement will serve as a marker of pelvic floor contraction, and the delta in the progression angle will serve as a marker for effective pushing.
- Finally, the provider will turn the screen again from the patient and repeat the first stage.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Transabdominal ultrasound will be applied to optimize the training program of contracting pelvic floor muscles, aiming to decrease postpartum urinary and fecal incontinence. Transperineal ultrasound will be used for pre-labor-coached maternal pushing aiming to improve pushing during the second stage of labor, reduce operative deliveries, the incidence of perineal tears, and urinary and fecal incontinence. Receives: Behavioral: Pre-labor ultrasound as a visual biofeedback device for maternal pushing education and pelvic floor training |
| Control group | No intervention | A pelvic floor physiotherapist will provide the participants with a verbal explanation of how to contract pelvic floor muscles. without ultrasound. |
| Standard care | No intervention | Questionnaires only at four timeline points - before delivery at recruitment (T0), a week later (T2), immediately postpartum (T3), and two months postpartum (T4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of the second stage of labor
measure by time (min/hour)
Measured: up to 1 week after labor
Secondary outcomes (4)
Mode of delivery
Number of Participants with spontaneous vaginal or operative delivery (operative assisted - vacuum-assisted, forceps assisted, cesarean delivery)
Measured: up to 1 week after labor
Perineal tears
Number of Participants with Perineal tears, specifically OASIS - obstetric anal sphincter Number of Participants with injuries
Measured: up to 1 week after labor
Urinary and fecal incontinence
Number of Participants with Urinary and/ or fecal incontinence
Measured: up to 1 week after labor, and 2 month after labor.
Fear of birth questionnaire
6-36, higher score mean worse outcome.
Measured: Baseline, a week later , 1 week after labor and two months after labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start18 Feb 2022
- Primary completion28 Jan 2024
- Study completion28 Jan 2024
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 Pregnancy RelatedStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ariel University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noa Ben Ami, PhD, Principal investigator, Ariel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258786
- Sponsor's protocol ID
- AU-HEA-NBA-20211128 Pre_labor
- Status last verified
- Jan 2024
- First submitted
- 8 Feb 2022
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ben-Ami N, Tischler T, Ruff SR, Hendin N, Hadar E, Rousseau S, Perlman S. Physiotherapist-led ultrasound-guided visual biofeedback prelabor training: a randomised controlled trial. BMC Pregnancy Childbirth. 2026 Mar 21;26(1):471. doi: 10.1186/s12884-026-08976-8.
PubMed 41862837
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-labor Ultrasound as a Visual Biofeedback Device for Maternal Pushing Education and Pelvic Floor Training - a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05258786
- Acronym / sponsor ID
- AU-HEA-NBA-20211128 Pre_labor
- Conditions
- Pregnancy Related, Delivery Complication
- Keywords
- pre-labor education, biofeedback, ultrasound, vaginal delivery, fear of childbirth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ariel UniversityUniversity, hospital or other
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- 28 Jan 2024 (actual)
- Study completion
- 28 Jan 2024 (actual)
- First posted
- 28 Feb 2022 (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.
The study will observe the effect of antenatal biofeedback with transperineal and abdominal ultrasound applied by a pelvic floor physical therapist. The training will focus on pelvic floor training and maternal-coached pushing with ultrasound-based visual biofeedback. The investigators aim to assess maternal and neonatal obstetrical outcomes, urinary and fecal incontinence, and maternal psychological effects.
Detailed description
Childbirth is a challenging process both emotionally and physically. The anxiety and anticipation accompanying pregnancy, labor, and delivery were reported to be relieved by pre-labor education, providing knowledge regarding the physiological process of labor to future parents.
Ultrasound examination enables the laboring women the opportunity to see fetal head movements in response to maternal pushing, and previous studies have revealed the physiological and psychological advantages of ultrasound-mediated intrapartum biofeedback during the second stage of labor.
Pre-labor sonographic maternal coaching has the advantage of a clean setting, avoiding the stressful, frequently hectic nature of labor and delivery wards, and may enable a more comprehensive implementation of the method, a structured training program, and better physical and psychological outcomes. All available literature regarding the application of intrapartum and pre-labor ultrasound refers to the examination performed by obstetricians.
The study will observe the effect of antenatal biofeedback with transperineal and abdominal ultrasound applied by a pelvic floor physical therapist. The training will focus on two aspects: pelvic floor training and maternal coached pushing - both with ultrasound-based visual biofeedback. The investigators aim to assess maternal and neonatal obstetrical outcomes, urinary and fecal incontinence, and maternal psychological outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Pre-labor ultrasound as a visual biofeedback device for maternal pushing education and pelvic floor trainingTransabdominal ultrasound will be applied to optimize the training program of contracting pelvic floor muscles, aiming to decrease postpartum urinary and fecal incontinence. Transperineal ultrasound will be used for pre-labor-coached maternal pushing aiming to improve pushing during the second stage of labor, reduce operative deliveries, the incidence of perineal tears, and urinary and fecal incontinence. |
| Control group | No intervention | –A pelvic floor physiotherapist will provide the participants with a verbal explanation of how to contract pelvic floor muscles. without ultrasound. |
| Standard care | No intervention | –Questionnaires only at four timeline points - before delivery at recruitment (T0), a week later (T2), immediately postpartum (T3), and two months postpartum (T4) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- pregnant nullipara women with a low-risk pregnancy who are planned for vaginal delivery. The biofeedback will occur at 36-42 gestational weeks.
Key exclusion criteria (1 listed)
- an inability to fill questionaries due to communication issues or cesarean section performed due to major obstetrical events.
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 |
|---|---|---|
| Pre-labor ultrasound as a visual biofeedback device for maternal pushing education and pelvic floor training1. Ultrasound examination with the screen turned to the provider will assess the bladder movements at rest and during contraction of the pelvic floor and fetal head descent at rest and during pushing. 2. The provider will turn the screen to the patient and explain the anatomical landmarks: bladder, fetal head, birth canal direction. 3. A repeat of the first stage (1) with the screen turned to the patient: the biofeedback process. Bladder displacement will serve as a marker of pelvic floor contraction, and the delta in the progression angle will serve as a marker for effective pushing. 4. Finally, the provider will turn the screen again from the patient and repeat the first stage. | Behavioural | Intervention group |
Primary outcome
length of the second stage of labor
Time frame: up to 1 week after labor
measure by time (min/hour)
4 secondary outcomes
Mode of delivery
Time frame: up to 1 week after labor
Perineal tears
Time frame: up to 1 week after labor
Urinary and fecal incontinence
Time frame: up to 1 week after labor, and 2 month after labor.
Fear of birth questionnaire
Time frame: Baseline, a week later , 1 week after labor and two months after labor
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Derived from this study: PubMed 41862837Ben-Ami N, Tischler T, Ruff SR, Hendin N, Hadar E, Rousseau S, Perlman S. Physiotherapist-led ultrasound-guided visual biofeedback prelabor training: a randomised controlled trial. BMC Pregnancy Childbirth. 2026 Mar 21;26(1):471. doi: 10.1186/s12884-026-08976-8.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Noa Ben Ami, PhD principal investigator
Ariel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-labor ultrasound as a visual biofeedback device for maternal pushing education and pelvic floor training in people with Pregnancy Related and Delivery Complication, run by Ariel University at 1 site in Israel.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 31 Jan 2024. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of the second stage of labor (time frame: up to 1 week after labor). 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 NCT05258786, 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 31 Jan 2024.