Clinical trial NCT05258786: Pre-labor Ultrasound as a Visual Biofeedback Device for Maternal Pushing Education
Official title: Pre-labor Ultrasound as a Visual Biofeedback Device for Maternal Pushing Education and Pelvic Floor Training - a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Delivery Complication
Keywords: pre-labor education
biofeedback
ultrasound
vaginal delivery
fear of childbirth
Lead sponsor: Ariel University
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 120
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: length of the second stage of labor
timeFrame: up to 1 week after labor
Secondary outcomes:
measure: Mode of delivery
timeFrame: up to 1 week after labor
measure: Perineal tears
timeFrame: up to 1 week after labor
measure: Urinary and fecal incontinence
timeFrame: up to 1 week after labor, and 2 month after labor.
measure: Fear of birth questionnaire
timeFrame: Baseline, a week later , 1 week after labor and two months after labor
Other outcomes:
Locations:
city: Ariel
country: Israel
facility: Noa Ben Ami
Study officials:
affiliation: Ariel University
name: Noa Ben Ami, PhD
role: PRINCIPAL_INVESTIGATOR
References: