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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midwife-led pushing training only group | Active Comparator | The pushing training program consists of a two-hour in-person session, structured as follows:
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| Midwife-led ultrasound-guided pushing training group | Experimental | The pushing training program consists of a two-hour in-person session, structured as follows:
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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midwife-led ultrasound-guided pushing training group | Other | The pushing training program consists of a two-hour in-person session, structured as follows:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gloria Anderson, PhD in Public Health | Contact | 00393484648419 | gloria.anderson@guest.policlinicogemelli.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UOC Ostetricia e Patologia Ostetrica | Recruiting | Rome | RM | 00168 | Italy |
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| Midwife-led pushing training only group | Other | The pushing training program consists of a two-hour in-person session, structured as follows:
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| Measured from the onset of active labor until the moment of birth |
| 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. | Measured after childbirth |
| Rate of perineal tears | Rates of perineal tears, measured as the proportion of women experiencing perineal lacerations of any degree | Baseline |
| 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. | Baseline |
| Operative delivery rates | Operative delivery rates, measured as the proportion of women who required instrumental assistance for vaginal birth, including vacuum or forceps-assisted delivery, excluding spontaneous vaginal and cesarean deliveries, as documented in the delivery records. | Baseline |
| Urinary incontinence rates | Urinary incontinence rates at 6 and 12 weeks postpartum, measured as the proportion of women reporting involuntary leakage of urine during activities such as coughing, sneezing, or exertion (stress urinary incontinence) or experiencing a sudden, strong urge to urinate (urge incontinence), as assessed through clinical evaluation at follow-up visits. | Measured at 6 and 12 weeks postpartum |