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Recruiting Not applicable

Pushing Using Real-time Sonographic Ultrasound Education

NCT07000240 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-07-19
Last updated
2025-08-22

Condition(s) studied

Transperineal UltrasoundMidwife-led Pushing Training ProgramDuration of the Second StageCoactivation Rates of Pelvic Floor MusclesMaternal SatisfactionPerineal Tear Rates

Investigational drug(s) / intervention(s)

Midwife-led ultrasound-guided pushing training groupMidwife-led pushing training only group

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.

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.

Study 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
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change of duration of the second stage of labor — 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.

Trial sites (1)

FacilityCityRegionStatus
UOC Ostetricia e Patologia Ostetrica Rome RM Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07000240 on ClinicalTrials.gov ↗ ← All trials in Italy