Real-time transperineal ultrasound-guided pushing training during pregnancy
Official title: Pushing Using Real-time Sonographic Ultrasound Education (PURSUE)
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT07000240 · Data updated 2026-11-12
This project will test whether adding a brief real-time ultrasound session to midwife-led pushing lessons helps pregnant, first-time mothers prepare for an easier and safer delivery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 136 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome, RM) |
| Status | Recruiting |
| Started | July 19, 2025 |
| Main results expected | January 27, 2026 |
| Study ends | May 27, 2026 |
| Registry record updated | August 22, 2025 |
| Trial ID | NCT07000240 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are nulliparous women in their second trimester with a singleton pregnancy who can understand Italian and plan to deliver at Fondazione Policlinico Agostino Gemelli IRCCS.
✕Probably not a fit
Patients unlikely to benefit include multiparous women, those with multiple gestation or known contraindications to vaginal delivery, prior major pelvic surgery, or those who cannot attend the in-person ultrasound session or deliver at the study site.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, open-label, randomized controlled study at Fondazione Policlinico Agostino Gemelli IRCCS enrolling nulliparous women in their second trimester who sign up for an online childbirth course. Participants are randomized to standard midwife-led pushing training or the same training plus a short transperineal ultrasound session that gives visual feedback on pushing technique. The primary outcome is duration of the second stage of labor, and secondary outcomes include pelvic floor muscle coactivation at delivery, perineal tear rates, vaginal delivery rate, postpartum urinary incontinence, and maternal satisfaction. Approximately 136 participants are planned to account for expected dropouts.
Why it matters
Potential benefit: If successful, this approach could shorten the pushing phase, reduce pelvic floor trauma, and improve maternal satisfaction and postpartum continence.
How similar studies have gone: Prior pilot and observational work suggests ultrasound can help visualize and teach pushing mechanics, but randomized evidence is limited and this approach remains relatively novel in controlled trials.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Nulliparous women in their second trimester (approximately 14-28 weeks of gestation). 2. Willingness to participate in the preparation training program on pushing techniques. 3. Singleton pregnancy. 4. Age 18 years or older. 5. Ability to understand and provide informed consent in Italian. 6. Plan to deliver at the Fondazione Policlinico Agostino Gemelli IRCCS. Exclusion Criteria: 1. Multifetal (e.g., twins, triplets) pregnancies. 2. Known obstetric complications or conditions that contraindicate a vaginal delivery (e.g., placenta previa). 3. Medical or psychiatric conditions that would prevent participation in the educational program or adherence to study protocols. 4. History of pelvic floor surgery or severe pelvic floor dysfunction that might affect participation or outcomes. 5. Inability to understand study requirements or provide informed consent. 6. Participants already enrolled in conflicting clinical trials or interventions that could influence the study's outcomes.
Where it's running
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UOC Ostetricia e Patologia Ostetrica
Rome, Rm, Italy Recruiting
Study contacts
- Study coordinator: Gloria Anderson, PhD in Public Health
- Email: gloria.anderson@guest.policlinicogemelli.it
- Phone: 00393484648419
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.