Skip to main content
Clinical Trials/NCT05258786
NCT05258786
Completed
Not Applicable

Pre-labor Ultrasound as a Visual Biofeedback Device for Maternal Pushing Education and Pelvic Floor Training - a Randomized Control Trial

Ariel University1 site in 1 country120 target enrollmentFebruary 18, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy Related
Sponsor
Ariel University
Enrollment
120
Locations
1
Primary Endpoint
length of the second stage of labor
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The study will observe the effect of antenatal biofeedback with transperineal and abdominal ultrasound applied by a pelvic floor physical therapist. The training will focus on pelvic floor training and maternal-coached pushing with ultrasound-based visual biofeedback. The investigators aim to assess maternal and neonatal obstetrical outcomes, urinary and fecal incontinence, and maternal psychological effects.

Detailed Description

Childbirth is a challenging process both emotionally and physically. The anxiety and anticipation accompanying pregnancy, labor, and delivery were reported to be relieved by pre-labor education, providing knowledge regarding the physiological process of labor to future parents. Ultrasound examination enables the laboring women the opportunity to see fetal head movements in response to maternal pushing, and previous studies have revealed the physiological and psychological advantages of ultrasound-mediated intrapartum biofeedback during the second stage of labor. Pre-labor sonographic maternal coaching has the advantage of a clean setting, avoiding the stressful, frequently hectic nature of labor and delivery wards, and may enable a more comprehensive implementation of the method, a structured training program, and better physical and psychological outcomes. All available literature regarding the application of intrapartum and pre-labor ultrasound refers to the examination performed by obstetricians. The study will observe the effect of antenatal biofeedback with transperineal and abdominal ultrasound applied by a pelvic floor physical therapist. The training will focus on two aspects: pelvic floor training and maternal coached pushing - both with ultrasound-based visual biofeedback. The investigators aim to assess maternal and neonatal obstetrical outcomes, urinary and fecal incontinence, and maternal psychological outcomes.

Registry
clinicaltrials.gov
Start Date
February 18, 2022
End Date
January 28, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • pregnant nullipara women with a low-risk pregnancy who are planned for vaginal delivery. The biofeedback will occur at 36-42 gestational weeks.

Exclusion Criteria

  • an inability to fill questionaries due to communication issues or cesarean section performed due to major obstetrical events.

Outcomes

Primary Outcomes

length of the second stage of labor

Time Frame: up to 1 week after labor

measure by time (min/hour)

Secondary Outcomes

  • Perineal tears(up to 1 week after labor)
  • Fear of birth questionnaire(Baseline, a week later , 1 week after labor and two months after labor)
  • Mode of delivery(up to 1 week after labor)
  • Urinary and fecal incontinence(up to 1 week after labor, and 2 month after labor.)

Study Sites (1)

Loading locations...

Similar Trials