RecruitingNot ApplicableNCT07000240

Pushing Using Real-time Sonographic Ultrasound Education

Pushing Using Real-time Sonographic Ultrasound Education (PURSUE)


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

136 participants

Start Date

Jul 19, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

  • 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.

Exclusion Criteria6

  • 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.

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Interventions

OTHERMidwife-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.

OTHERMidwife-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.


Locations(1)

UOC Ostetricia e Patologia Ostetrica

Rome, RM, Italy

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NCT07000240


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