NCT07000240 Pushing Using Real-time Sonographic Ultrasound Education
| NCT ID | NCT07000240 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Transperineal Ultrasound |
| Study Type | INTERVENTIONAL |
| Enrollment | 136 participants |
| Start Date | 2025-07-19 |
| Primary Completion | 2026-01-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 136 participants in total. It began in 2025-07-19 with a primary completion date of 2026-01-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility 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.
Contact & Investigator
Gloria Anderson, PhD in Public Health
✉ gloria.anderson@guest.policlinicogemelli.it📞 00393484648419
Frequently Asked Questions
Who can join the NCT07000240 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Transperineal Ultrasound. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07000240 currently recruiting?
Yes, NCT07000240 is actively recruiting participants. Contact the research team at gloria.anderson@guest.policlinicogemelli.it for enrollment information.
Where is the NCT07000240 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT07000240 clinical trial?
NCT07000240 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 136 participants.