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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07675642
Acronym
CoA_2025
Enrollment
204
Registered
2026-06-30
Start date
2026-04-22
Completion date
2031-07-01
Last updated
2026-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

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.

Interventions

DIAGNOSTIC_TESTUltrasound Visual Feedback Training

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.

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
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.Measured during the second stage of labor (from full cervical dilation to fetal delivery)Assessed at delivery; calculated as the duration (minutes) from complete cervical dilation to fetal delivery.

Countries

Italy

Contacts

CONTACTElena Brunelli, MD
elena_brunelli@aosp.bo.it0512144377

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 1, 2026