Clinical trial NCT07000240: Pushing Using Real-time Sonographic Ultrasound Education
Official title: Pushing Using Real-time Sonographic Ultrasound Education (PURSUE)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Transperineal Ultrasound
Midwife-led Pushing Training Program
Duration of the Second Stage
Coactivation Rates of Pelvic Floor Muscles
Maternal Satisfaction
Perineal Tear Rates
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-06-02
Enrollment: 136
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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 outcomes:
measure: Change of duration of the second stage of labor
timeFrame: Measured from the onset of active labor until the moment of birth.
Secondary outcomes:
measure: Levator ani muscle (LAM) coactivation rates
timeFrame: Measured from the onset of active labor until the moment of birth
measure: Women's satisfaction
timeFrame: Measured after childbirth
measure: Rate of perineal tears
timeFrame: Baseline
measure: Vaginal delivery rates
timeFrame: Baseline
measure: Operative delivery rates
timeFrame: Baseline
measure: Urinary incontinence rates
timeFrame: Measured at 6 and 12 weeks postpartum
Other outcomes:
Locations:
Study officials:
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