Labor Stage, SecondNCT06857552
The Effect of Ultrasound Guided Visual Biofeedback Performed by Midwifes on the Duration of the Active Second Stage of Labor
A study testing Visual biofeedback using transperineal ultrasound (TPUS) in people with Labor Stage, Second, run by Kaplan Medical Center at 1 site in Israel.
Trial summary
The goal of this randomized controlled trial is to investigate whether using of coached sonographic pushing will decrease the length of the second stage of labor and the rate of operative deliveries. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Stage, Second
- What is being tested?
- Visual biofeedback using transperineal ultrasound (TPUS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteIsrael
- Study dates
- 3 May 2021to 7 Sep 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
- Singleton pregnancy
- Nulliparous
- 37-42 weeks of gestation
- Under neuroaxial analgesia
- Reached the second stage of labor
- An estimated fetal weight between 2500-4000 grams
Who cannot join
- Women who arrived in active labor and delivered before being assessed by a physician.
- Women with contra-indications for vaginal birth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Ultrasound Guided Visual Biofeedback Performed by Midwifes on the Duration of the Active Second Stage of Labor, a Randomized Controlled Trial
The goal of this randomized controlled trial is to investigate whether using of coached sonographic pushing will decrease the length of the second stage of labor and the rate of operative deliveries.
Researchers will compare women who undergo the traditional coached pushing to women who undergo visual biofeedback coached pushing.
- Conditions
- Labor Stage, Second
- Being tested
- Visual biofeedback using transperineal ultrasound (TPUS)
- Keywords
- Prolonged second stage, Transperineal ultrasound, biofeedback
- 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 using transperineal ultrasound (TPUS)Other
The intervention (study) arm will recieve coached maternal pushing via transperineal ultrasound (US) with visual biofeedback
| Study group | Role | What they receive |
|---|---|---|
| Coached maternal pushing via ultrasound (US) | Experimental | The study group, will have coached pushing using trans-perinal ultrasound (US) performed by the midwife during the active stage of labor, and after diagnosis of complete dilatation. Further, if not delivered within 2 hours of complete dilatation, a third coaching will be conducted. The coaching process in each will be performed for 10 minutes and for at least 3 contractions.
In the study group the women will observe the fetal head movements on the screen in front of her. Receives: Other: Visual biofeedback using transperineal ultrasound (TPUS) |
| Traditional coached maternal pushing | No intervention | The control group will have the traditional coached pushing (vaginal) performed by a midwide during the active stage of labor, and after diagnosis of complete dilatation. Further, if not delivered within 2 hours of complete dilatation, a third coaching will be conducted. The coaching process in each will be performed for 10 minutes and for at least 3 contractions The women in the controlled group will have the vocal coaching of the midwife during the contractions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of the second stage of labor
To investigate whether using of coached sonographic pushing will decrease the length of the second stage of labor.
Measured: At baseline
Mode of delivery
To investigate whether using of coached sonographic pushing will affect the rate of operative deliveries.
Measured: At baseline
Secondary outcomes (3)
Maternal outcomes
Maternal 3rd or 4th degree tear rate, postpartum hemorrhage rates
Measured: At baseline
Neonatal Outcomes
Neonatal cord PH
Measured: At baseline
Neonatal Outcomes
Apgar score less than 7 in 5 minutes.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start3 May 2021
- Primary completion3 May 2021
- Study completion7 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Labor Stage, SecondStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaplan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roni Levy, Kaplan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857552
- Sponsor's protocol ID
- 0029-21-KMC
- Status last verified
- Feb 2025
- First submitted
- 23 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bellussi F, Alcamisi L, Guizzardi G, Parma D, Pilu G. Traditionally vs sonographically coached pushing in second stage of labor: a pilot randomized controlled trial. Ultrasound Obstet Gynecol. 2018 Jul;52(1):87-90. doi: 10.1002/uog.19044. Epub 2018 May 30.
PubMed 29532533Gilboa Y, Frenkel TI, Schlesinger Y, Rousseau S, Hamiel D, Achiron R, Perlman S. Visual biofeedback using transperineal ultrasound in second stage of labor. Ultrasound Obstet Gynecol. 2018 Jul;52(1):91-96. doi: 10.1002/uog.18962. Epub 2018 May 29.
PubMed 29155474
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ultrasound Guided Visual Biofeedback Performed by Midwifes on the Duration of the Active Second Stage of Labor, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06857552
- Acronym / sponsor ID
- 0029-21-KMC
- Conditions
- Labor Stage, Second
- Keywords
- Prolonged second stage, Transperineal ultrasound, biofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Kaplan Medical CenterUniversity, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- 3 May 2021 (actual)
- Study completion
- 7 Sep 2024 (actual)
- First posted
- 4 Mar 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.
The goal of this randomized controlled trial is to investigate whether using of coached sonographic pushing will decrease the length of the second stage of labor and the rate of operative deliveries.
Researchers will compare women who undergo the traditional coached pushing to women who undergo visual biofeedback coached pushing.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coached maternal pushing via ultrasound (US) | Experimental | Other: Visual biofeedback using transperineal ultrasound (TPUS)The study group, will have coached pushing using trans-perinal ultrasound (US) performed by the midwife during the active stage of labor, and after diagnosis of complete dilatation. Further, if not delivered within 2 hours of complete dilatation, a third coaching will be conducted. The coaching process in each will be performed for 10 minutes and for at least 3 contractions. In the study group the women will observe the fetal head movements on the screen in front of her. |
| Traditional coached maternal pushing | No intervention | –The control group will have the traditional coached pushing (vaginal) performed by a midwide during the active stage of labor, and after diagnosis of complete dilatation. Further, if not delivered within 2 hours of complete dilatation, a third coaching will be conducted. The coaching process in each will be performed for 10 minutes and for at least 3 contractions The women in the controlled group will have the vocal coaching of the midwife during the contractions. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Singleton pregnancy
- Nulliparous
- 37-42 weeks of gestation
- Under neuroaxial analgesia
- Reached the second stage of labor
Key exclusion criteria (2 listed)
- Women who arrived in active labor and delivered before being assessed by a physician.
- Women with contra-indications for vaginal birth
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 using transperineal ultrasound (TPUS)The intervention (study) arm will recieve coached maternal pushing via transperineal ultrasound (US) with visual biofeedback | Other | Coached maternal pushing via ultrasound (US) |
Primary outcome
Length of the second stage of labor
Time frame: At baseline
To investigate whether using of coached sonographic pushing will decrease the length of the second stage of labor.
Mode of delivery
Time frame: At baseline
To investigate whether using of coached sonographic pushing will affect the rate of operative deliveries.
3 secondary outcomes
Maternal outcomes
Time frame: At baseline
Neonatal Outcomes
Time frame: At baseline
Neonatal Outcomes
Time frame: At baseline
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 4 Mar 2025.
- Background: PubMed 29532533Bellussi F, Alcamisi L, Guizzardi G, Parma D, Pilu G. Traditionally vs sonographically coached pushing in second stage of labor: a pilot randomized controlled trial. Ultrasound Obstet Gynecol. 2018 Jul;52(1):87-90. doi: 10.1002/uog.19044. Epub 2018 May 30.
- Background: PubMed 29155474Gilboa Y, Frenkel TI, Schlesinger Y, Rousseau S, Hamiel D, Achiron R, Perlman S. Visual biofeedback using transperineal ultrasound in second stage of labor. Ultrasound Obstet Gynecol. 2018 Jul;52(1):91-96. doi: 10.1002/uog.18962. Epub 2018 May 29.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 using transperineal ultrasound (TPUS) in people with Labor Stage, Second, run by Kaplan Medical Center 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 6 inclusion and 2 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 4 Mar 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 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: At baseline). 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 NCT06857552, which also lists 2 linked publications.
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 4 Mar 2025.