Transperineal UltrasoundPURSUENCT07000240
Pushing Using Real-time Sonographic Ultrasound Education
A study testing Midwife-led ultrasound-guided pushing training group and Midwife-led pushing training only group in people with Transperineal Ultrasound and Midwife-led Pushing Training Program, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The study aims to assess whether the use of ultrasound during a pushing lesson can facilitate easier and safer childbirth. The research will be conducted at a single hospital and will involve pregnant women in their second trimester who enroll in an online childbirth course. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Transperineal Ultrasound, Midwife-led Pushing Training Program, Duration of the Second Stage
- What is being tested?
- Midwife-led ultrasound-guided pushing training group and Midwife-led pushing training only group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteItaly
- Study dates
- 19 Jul 2025to 27 May 2026
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nulliparous women in their second trimester (approximately 14-28 weeks of gestation).
- Willingness to participate in the preparation training program on pushing techniques.
- Singleton pregnancy.
- Age 18 years or older.
- Ability to understand and provide informed consent in Italian.
- Plan to deliver at the Fondazione Policlinico Agostino Gemelli IRCCS.
Who cannot join
- Multifetal (e.g., twins, triplets) pregnancies.
- Known obstetric complications or conditions that contraindicate a vaginal delivery (e.g., placenta previa).
- Medical or psychiatric conditions that would prevent participation in the educational program or adherence to study protocols.
- History of pelvic floor surgery or severe pelvic floor dysfunction that might affect participation or outcomes.
- Inability to understand study requirements or provide informed consent.
- Participants already enrolled in conflicting clinical trials or interventions that could influence the study's outcomes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gloria Anderson, PhD in Public Health contact
Italy1 site, 1 recruiting
- Recruiting
UOC Ostetricia e Patologia Ostetrica
Rome, RM, 00168
Gloria Anderson, PhD, 3484648419, gloria.anderson@unicatt.it
Jessica Preziosi, PhD, jessica.preziosi@policlinicogemelli.it
About this study
Official title: Pushing Using Real-time Sonographic Ultrasound Education (PURSUE)
The study aims to assess whether the use of ultrasound during a pushing lesson can facilitate easier and safer childbirth. The research will be conducted at a single hospital and will involve pregnant women in their second trimester who enroll in an online childbirth course. Participants will be randomly assigned to one of two groups:
One group will receive standard pushing instructions from a midwife.
Read more
The other group will receive the same instructions along with a brief ultrasound session to visually support correct pushing techniques.
The primary outcome is a potential reduction in the duration of the second stage of labor (when the baby is being delivered). Secondary outcomes include improved coordination of pelvic floor muscles, fewer perineal tears, a higher rate of vaginal births, reduced postnatal urinary incontinence, and greater maternal satisfaction.
Approximately 136 women will be enrolled in the study (accounting for potential dropouts). The expectation is that this integrated teaching approach will enhance the effectiveness, safety, and overall experience of pushing during labor for both mothers and their newborns.
Read the detailed description
This single-center, open-label, parallel-group randomized controlled trial aims to evaluate whether integrating transperineal ultrasound into a midwife-led pushing training program can reduce pelvic floor muscle coactivation during childbirth. Pregnant women in their second trimester, recruited from an online pre-childbirth course at Fondazione Policlinico Agostino Gemelli IRCCS, will be randomized to receive either standard midwife-led training or additional ultrasound-guided instruction. The primary outcome is the reduction in the duraction of the second stage of labour, with secondary outcomes including coactivation rates of pelvic floor muscles at delivery, maternal satisfaction, perineal tear rates, vaginal delivery rates, and postpartum urinary incontinence. With an estimated sample size of 136 participants accounting for a 15% dropout, the study anticipates that ultrasound-guided training will improve pushing efficiency, decrease pelvic trauma, and enhance delivery outcomes.
- Conditions
- Transperineal Ultrasound, Midwife-led Pushing Training Program, Duration of the Second Stage, Coactivation Rates of Pelvic Floor Muscles, Maternal Satisfaction, Perineal Tear Rates
- Being tested
- Midwife-led ultrasound-guided pushing training group, Midwife-led pushing training only group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midwife-led ultrasound-guided pushing training groupOther
The pushing training program consists of a two-hour in-person session, structured as follows:
- 30 minutes of theoretical instruction, covering the physiological mechanisms of labor, the role of the levator ani muscle (LAM) during pushing, and optimal pushing techniques.
- 30 minutes of practical exercises, during which women will be guided through breathing techniques, pushing strategies, and perineal relaxation.
Women randomized to the ultrasound-guided pushing training group will receive additional transperineal ultrasound (TPU) evaluations during practical exercises, performed by a midwife trained in ultrasound imaging. These assessments will ensure effective LAM relaxation during pushing practices and provide real-time visual feedback to optimize muscle coordination.
Midwife-led pushing training only groupOther
The pushing training program consists of a two-hour in-person session, structured as follows:
- 30 minutes of theoretical instruction, covering the physiological mechanisms of labor, the role of the levator ani muscle (LAM) during pushing, and optimal pushing techniques.
- 30 minutes of practical exercises, during which women will be guided through breathing techniques, pushing strategies, and perineal relaxation.
| Study group | Role | What they receive |
|---|---|---|
| Midwife-led pushing training only group | Active comparator | The pushing training program consists of a two-hour in-person session, structured as follows:
* 30 minutes of theoretical instruction, covering the physiological mechanisms of labor, the role of the levator ani muscle (LAM) during pushing, and optimal pushing techniques.
* 30 minutes of practical exercises, during which women will be guided through breathing techniques, pushing strategies, and perineal relaxation. Receives: Other: Midwife-led pushing training only group |
| Midwife-led ultrasound-guided pushing training group | Experimental | The pushing training program consists of a two-hour in-person session, structured as follows:
* 30 minutes of theoretical instruction, covering the physiological mechanisms of labor, the role of the levator ani muscle (LAM) during pushing, and optimal pushing techniques.
* 30 minutes of practical exercises, during which women will be guided through breathing techniques, pushing strategies, and perineal relaxation.
Women randomized to the ultrasound-guided pushing training group will receive additional transperineal ultrasound (TPU) evaluations during practical exercises, performed by a midwife trained in ultrasound imaging. These assessments will ensure effective LAM relaxation during pushing practices and provide real-time visual feedback to optimize muscle coordination. Receives: Other: Midwife-led ultrasound-guided pushing training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of duration of the second stage of labor
Change in duration (minuts) of the second stage of labor in the experimental arm compared with the control arm, defined as the elapsed time between complete cervical dilation and fetal expulsion.
Measured: Measured from the onset of active labor until the moment of birth.
Secondary outcomes (6)
Levator ani muscle (LAM) coactivation rates
The levator ani muscle (LAM) coactivation rates were measured using transperineal ultrasound, evaluating the anteroposterior diameter (APD) of the levator hiatus at rest, during maximum pelvic floor muscle contraction, and during maximum Valsalva maneuver (both before and after visual feedback), with LAM coactivation defined as a reduction in APD on Valsalva compared to the resting state.
Measured: Measured from the onset of active labor until the moment of birth
Women's satisfaction
Women's satisfaction with the childbirth experience and with the training program, measured through the Associazione dei Ginecologi Italiani (AGOI) women's satisfaction with childbirth care Likert Scale.
Measured: Measured after childbirth
Rate of perineal tears
Rates of perineal tears, measured as the proportion of women experiencing perineal lacerations of any degree
Measured: Baseline
Vaginal delivery rates
Vaginal delivery rates, measured as the proportion of women who achieved spontaneous or assisted vaginal birth (including vacuum or forceps-assisted delivery), excluding cesarean sections, as documented in the delivery records.
Measured: Baseline
Operative delivery rates
Operative delivery rates, measured as the proportion of women who required instrumental assistance for vaginal birth, including vacuum or forceps-assisted delivery, excluding spontaneous vaginal and cesarean deliveries, as documented in the delivery records.
Measured: Baseline
Urinary incontinence rates
Urinary incontinence rates at 6 and 12 weeks postpartum, measured as the proportion of women reporting involuntary leakage of urine during activities such as coughing, sneezing, or exertion (stress urinary incontinence) or experiencing a sudden, strong urge to urinate (urge incontinence), as assessed through clinical evaluation at follow-up visits.
Measured: Measured at 6 and 12 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2025
- Study start19 Jul 2025
- Primary completion27 Jan 2026 (estimated)
- Study completion27 May 2026 (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 Transperineal UltrasoundStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anderson Gloria, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000240
- Sponsor's protocol ID
- ID 7591
- Acronym
- PURSUE
- Status last verified
- Aug 2025
- First submitted
- 20 May 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Anderson G, Neri C, Di Pasquo E, Martino C, Tartaglia S, Danza M, Preziosi J, De Fermo LB, Filippini A, Anselmo M, Sciabbarrasi V, Sorrentino C, Miccoli R, Ottaviani M, Di Battista R, Ghi T. Pushing using real-time sonographic ultrasound education (PURSUE): A study protocol for a randomized controlled trial. PLoS One. 2026 Aug 14;21(8):e0352315. doi: 10.1371/journal.pone.0352315. eCollection 2026.
PubMed 42599898
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pushing Using Real-time Sonographic Ultrasound Education (PURSUE)
- ClinicalTrials.gov ID
- NCT07000240
- Acronym / sponsor ID
- PURSUE / ID 7591
- Conditions
- Transperineal Ultrasound, Midwife-led Pushing Training Program, Duration of the Second Stage, Coactivation Rates of Pelvic Floor Muscles, Maternal Satisfaction, Perineal Tear Rates
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 19 Jul 2025 (actual)
- Primary completion
- 27 Jan 2026 (estimated)
- Study completion
- 27 May 2026 (estimated)
- First posted
- 2 Jun 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 study aims to assess whether the use of ultrasound during a pushing lesson can facilitate easier and safer childbirth. The research will be conducted at a single hospital and will involve pregnant women in their second trimester who enroll in an online childbirth course. Participants will be randomly assigned to one of two groups:
One group will receive standard pushing instructions from a midwife.
The other group will receive the same instructions along with a brief ultrasound session to visually support correct pushing techniques.
The primary outcome is a potential reduction in the duration of the second stage of labor (when the baby is being delivered). Secondary outcomes include improved coordination of pelvic floor muscles, fewer perineal tears, a higher rate of vaginal births, reduced postnatal urinary incontinence, and greater maternal satisfaction.
Approximately 136 women will be enrolled in the study (accounting for potential dropouts). The expectation is that this integrated teaching approach will enhance the effectiveness, safety, and overall experience of pushing during labor for both mothers and their newborns.
Detailed description
This single-center, open-label, parallel-group randomized controlled trial aims to evaluate whether integrating transperineal ultrasound into a midwife-led pushing training program can reduce pelvic floor muscle coactivation during childbirth. Pregnant women in their second trimester, recruited from an online pre-childbirth course at Fondazione Policlinico Agostino Gemelli IRCCS, will be randomized to receive either standard midwife-led training or additional ultrasound-guided instruction. The primary outcome is the reduction in the duraction of the second stage of labour, with secondary outcomes including coactivation rates of pelvic floor muscles at delivery, maternal satisfaction, perineal tear rates, vaginal delivery rates, and postpartum urinary incontinence. With an estimated sample size of 136 participants accounting for a 15% dropout, the study anticipates that ultrasound-guided training will improve pushing efficiency, decrease pelvic trauma, and enhance delivery outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midwife-led pushing training only group | Active comparator | Other: Midwife-led pushing training only groupThe pushing training program consists of a two-hour in-person session, structured as follows: * 30 minutes of theoretical instruction, covering the physiological mechanisms of labor, the role of the levator ani muscle (LAM) during pushing, and optimal pushing techniques. * 30 minutes of practical exercises, during which women will be guided through breathing techniques, pushing strategies, and perineal relaxation. |
| Midwife-led ultrasound-guided pushing training group | Experimental | Other: Midwife-led ultrasound-guided pushing training groupThe pushing training program consists of a two-hour in-person session, structured as follows: * 30 minutes of theoretical instruction, covering the physiological mechanisms of labor, the role of the levator ani muscle (LAM) during pushing, and optimal pushing techniques. * 30 minutes of practical exercises, during which women will be guided through breathing techniques, pushing strategies, and perineal relaxation. Women randomized to the ultrasound-guided pushing training group will receive additional transperineal ultrasound (TPU) evaluations during practical exercises, performed by a midwife trained in ultrasound imaging. These assessments will ensure effective LAM relaxation during pushing practices and provide real-time visual feedback to optimize muscle coordination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Nulliparous women in their second trimester (approximately 14-28 weeks of gestation).
- Willingness to participate in the preparation training program on pushing techniques.
- Singleton pregnancy.
- Age 18 years or older.
- Ability to understand and provide informed consent in Italian.
Key exclusion criteria (6 listed)
- Multifetal (e.g., twins, triplets) pregnancies.
- Known obstetric complications or conditions that contraindicate a vaginal delivery (e.g., placenta previa).
- Medical or psychiatric conditions that would prevent participation in the educational program or adherence to study protocols.
- History of pelvic floor surgery or severe pelvic floor dysfunction that might affect participation or outcomes.
- Inability to understand study requirements or provide informed consent.
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 |
|---|---|---|
| Midwife-led ultrasound-guided pushing training groupThe pushing training program consists of a two-hour in-person session, structured as follows: * 30 minutes of theoretical instruction, covering the physiological mechanisms of labor, the role of the levator ani muscle (LAM) during pushing, and optimal pushing techniques. * 30 minutes of practical exercises, during which women will be guided through breathing techniques, pushing strategies, and perineal relaxation. Women randomized to the ultrasound-guided pushing training group will receive additional transperineal ultrasound (TPU) evaluations during practical exercises, performed by a midwife trained in ultrasound imaging. These assessments will ensure effective LAM relaxation during pushing practices and provide real-time visual feedback to optimize muscle coordination. | Other | Midwife-led ultrasound-guided pushing training group |
| Midwife-led pushing training only groupThe pushing training program consists of a two-hour in-person session, structured as follows: * 30 minutes of theoretical instruction, covering the physiological mechanisms of labor, the role of the levator ani muscle (LAM) during pushing, and optimal pushing techniques. * 30 minutes of practical exercises, during which women will be guided through breathing techniques, pushing strategies, and perineal relaxation. | Other | Midwife-led pushing training only group |
Primary outcome
Change of duration of the second stage of labor
Time frame: Measured from the onset of active labor until the moment of birth.
Change in duration (minuts) of the second stage of labor in the experimental arm compared with the control arm, defined as the elapsed time between complete cervical dilation and fetal expulsion.
6 secondary outcomes
Levator ani muscle (LAM) coactivation rates
Time frame: Measured from the onset of active labor until the moment of birth
Women's satisfaction
Time frame: Measured after childbirth
Rate of perineal tears
Time frame: Baseline
Vaginal delivery rates
Time frame: Baseline
Operative delivery rates
Time frame: Baseline
Urinary incontinence rates
Time frame: Measured at 6 and 12 weeks postpartum
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 22 Aug 2025.
- Derived from this study: PubMed 42599898Anderson G, Neri C, Di Pasquo E, Martino C, Tartaglia S, Danza M, Preziosi J, De Fermo LB, Filippini A, Anselmo M, Sciabbarrasi V, Sorrentino C, Miccoli R, Ottaviani M, Di Battista R, Ghi T. Pushing using real-time sonographic ultrasound education (PURSUE): A study protocol for a randomized controlled trial. PLoS One. 2026 Aug 14;21(8):e0352315. doi: 10.1371/journal.pone.0352315. eCollection 2026.
- Individual participant dataSharing planned: Yes
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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.
Gloria Anderson, PhD in Public Health contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midwife-led ultrasound-guided pushing training group and Midwife-led pushing training only group in people with Transperineal Ultrasound and Midwife-led Pushing Training Program, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 6 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: looking for participants now, as of the sponsor's last update on 22 Aug 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 Italy. 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 Gloria Anderson, PhD in Public Health (00393484648419, gloria.anderson@guest.policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of duration of the second stage of labor (time frame: Measured from the onset of active labor until the moment of birth.). 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 NCT07000240, 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 22 Aug 2025.