The Effect of Ultrasound Visual Feedback on Birth Outcomes in Nulliparous Women With Levator Ani Muscle Co-activation at Term Pregnancy

NCT07675642 | Recruiting

• 1 other identifier: CoA_2025
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate the effect of ultrasound-based visual feedback training of the pelvic floor muscles in nulliparous women at term pregnancy who present co-activation of the levator ani muscle, on the duration of the second stage of labor. This is a single-center, no-profit, randomized controlled interventional study. Compared with standard clinical practice, patients will be enrolled at term pregnancy during routine antenatal care, when a first session of ultrasound-based visual feedback training will be performed using transperineal ultrasound. Nulliparous women at term pregnancy showing co-activation of the levator ani muscle will be recruited within the standard care pathway. Participants will be randomized into two groups: Group 1 (intervention): patients will undergo ultrasound-based visual feedback training, including real-time visualization on the ultrasound screen and explanation of the most appropriate pushing technique. Group 2 (control): patients will receive only verbal instruction regarding the appropriate pushing technique. Given the absence of known major confounding factors, simple randomization will be used. The randomization list will be generated electronically using the REDCap platform. Recruitment will take place in the outpatient clinics of the Obstetrics and Prenatal Medicine Unit (U.O.C) at IRCCS AOU di Bologna, Sant'Orsola Hospital. Women in the intervention group will receive two ultrasound training sessions (visual feedback) one week apart at term pregnancy. Women in the control group, after enrollment, will be informed about the phenomenon of levator ani co-activation and will receive verbal instructions on how to relax the pelvic floor muscles. After delivery, maternal and neonatal outcomes will be assessed, including mode of delivery, indication for operative vaginal delivery if applicable, duration of the second stage of labor, vaginal-perineal lacerations, other puerperal complications, neonatal arterial and venous pH, base excess (BE), birth weight, and neonatal intensive care unit (NICU) admission. Data will be collected through review of medical records at 40 days postpartum.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

• To evaluate the effect of ultrasound-based visual feedback training of the pelvic floor muscles in nulliparous women at term pregnancy presenting co-activation of the levator ani muscle, on the duration of the second stage of labor.

  Assessed at delivery; calculated as the duration (minutes) from complete cervical dilation to fetal delivery.

  Measured during the second stage of labor (from full cervical dilation to fetal delivery)

Study Arms (2)

Ultrasound Visual Feedback Training

EXPERIMENTAL

Participants receive ultrasound-based visual feedback training of the pelvic floor muscles using transperineal ultrasound. The intervention includes real-time visualization of pelvic floor muscle activity on the ultrasound screen, combined with structured instruction on optimal pushing techniques. Training is performed in two antenatal sessions at term pregnancy, one week apart.

Diagnostic Test: Ultrasound Visual Feedback Training

Verbal Instruction (Standard Care)

NO INTERVENTION

Participants receive standard care consisting of verbal instruction regarding appropriate pushing techniques during labor and guidance on relaxation of the pelvic floor muscles in the presence of levator ani co-activation. No ultrasound visual feedback is provided.

Interventions

Ultrasound Visual Feedback Training DIAGNOSTIC_TEST

Participants receive ultrasound-based visual feedback training of the pelvic floor muscles using transperineal ultrasound. The intervention includes real-time visualization of pelvic floor muscle activity on the ultrasound screen, combined with structured instruction on optimal pushing techniques. Training is performed in two antenatal sessions at term pregnancy, one week apart.

Ultrasound Visual Feedback Training

Eligibility Criteria

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

You may qualify if:

• Nulliparous (first pregnancy)
• Adults (≥18 years old)
• Singleton pregnancy
• Presence of levator ani muscle co-activation at term pregnancy (37 weeks)
• Candidates for vaginal delivery
• Written informed consent signed for study participation

You may not qualify if:

• Presence of uterine malformations
• Presence of fetal malformations
• Presence of vaginal bleeding at the time of enrollment
• Regular uterine contractions
• Premature rupture of membranes

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

Central Study Contacts

Elena Brunelli, MD

CONTACT

0512144377; elena_brunelli@aosp.bo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized in a 1:1 ratio to either ultrasound-based visual feedback training or verbal instruction only.

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: June 30, 2026
• Study Start: April 22, 2026
• Primary Completion (Estimated): May 13, 2031
• Study Completion (Estimated): July 1, 2031
• Last Updated: June 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)