Pushing Using Real-time Sonographic Ultrasound Education

NCT07000240 | Recruiting DMC

• 1 other identifier: ID 7591
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Transperineal Ultrasound; Midwife-led Pushing Training Program; Duration of the Second Stage; Coactivation Rates of Pelvic Floor Muscles; Maternal Satisfaction; Perineal Tear Rates

Outcome Measures

Primary Outcomes (1)

• Change of duration of the second stage of labor

  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.

  Measured from the onset of active labor until the moment of birth.

Secondary Outcomes (6)

• Levator ani muscle (LAM) coactivation rates

  Measured from the onset of active labor until the moment of birth

• Women's satisfaction

  Measured after childbirth

• Rate of perineal tears

  Baseline

• Vaginal delivery rates

  Baseline

• Operative delivery rates

  Baseline

Study Arms (2)

Midwife-led pushing training only group

ACTIVE COMPARATOR

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.

Other: Midwife-led pushing training only group

Midwife-led ultrasound-guided pushing training group

EXPERIMENTAL

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 ultrasound-guided pushing training group

Interventions

Midwife-led ultrasound-guided pushing training group OTHER

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 ultrasound-guided pushing training group

Midwife-led pushing training only group OTHER

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.

Midwife-led pushing training only group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

UOC Ostetricia e Patologia Ostetrica

Rome, RM, 00168, Italy

RECRUITING

Central Study Contacts

Gloria Anderson, PhD in Public Health

CONTACT

00393484648419; gloria.anderson@guest.policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Midwifery

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 2, 2025
• Study Start: July 19, 2025
• Primary Completion: January 27, 2026
• Study Completion (Estimated): May 27, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

IT (1)