Pushing Using Real-time Sonographic Ultrasound Education

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Midwife-led ultrasound-guided pushing training group

    Other intervention

    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

    Other intervention

    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.

Treatment groups

136 Participants
are divided into 2 treatment groups
Group A: Midwife-led pushing training only groupActive comparator 1 intervention
Group B: Midwife-led ultrasound-guided pushing training groupExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Levator ani muscle (LAM) coactivation rates

The levator ani muscle (LAM) coactivation rates were measured using transperineal ultrasound, evaluating the anteroposterior diameter (APD) of the levator hiatus at rest, during maximum pelvic floor muscle contraction, and during maximum Valsalva maneuver (both before and after visual feedback), with LAM coactivation defined as a reduction in APD on Valsalva compared to the resting state.

Time frame
Measured from the onset of active labor until the moment of birth
2

Women's satisfaction

Women's satisfaction with the childbirth experience and with the training program, measured through the Associazione dei Ginecologi Italiani (AGOI) women's satisfaction with childbirth care Likert Scale.

Time frame
Measured after childbirth
3

Rate of perineal tears

Rates of perineal tears, measured as the proportion of women experiencing perineal lacerations of any degree

Time frame
Baseline
4

Vaginal delivery rates

Vaginal delivery rates, measured as the proportion of women who achieved spontaneous or assisted vaginal birth (including vacuum or forceps-assisted delivery), excluding cesarean sections, as documented in the delivery records.

Time frame
Baseline

Other outcomes

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