The Effect of Ultrasound Visual Feedback on Birth Outcomes in Nulliparous Women With Levator Ani Muscle Co-activation at Term Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultrasound Visual Feedback Training.
- Who it may be relevant to
- Registry conditions: Pregnancy. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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 test Ultrasound 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.
Primary outcome measures
- 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. [Time frame: Measured during the second stage of labor (from full cervical dilation to fetal delivery)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Identifiers
NCT: NCT07675642 · CoA_2025