NCT07000240

Pushing Using Real-time Sonographic Ultrasound Education

Pushing Using Real-time Sonographic Ultrasound Education (PURSUE)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
OTHER	Midwife-led ultrasound-guided pushing training group	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.
OTHER	Midwife-led pushing training only group	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.

Timeline

• Start date: 2025-07-19
• Primary completion: 2026-01-27
• Completion: 2026-05-27
• First posted: 2025-06-02
• Last updated: 2025-08-22

Locations

1 site across 1 country: Italy