Pre-labor Ultrasound as a Visual Biofeedback Device for Maternal Pushing Education

Not Applicable

Completed

• Conditions: Delivery Complication; Pregnancy Related
• Interventions: Behavioral: Pre-labor ultrasound as a visual biofeedback device for maternal pushing education and pelvic floor training

• Registration Number: NCT05258786
• Lead Sponsor: Ariel University

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.

Study Timeline

• Study First Submitted: 2022-02-08
• Study First Submitted QC: 2022-02-17
• Study Start: 2022-02-18
• Study First Posted: 2022-02-28
• Status Verified: 2024-01
• Primary Completion: 2024-01-28
• Study Completion: 2024-01-28
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Pre-labor ultrasound as a visual biofeedback device for maternal pushing education and pelvic floor training	Transabdominal ultrasound will be applied to optimize the training program of contracting pelvic floor muscles, aiming to decrease postpartum urinary and fecal incontinence. Transperineal ultrasound will be used for pre-labor-coached maternal pushing aiming to improve pushing during the second stage of labor, reduce operative deliveries, the incidence of perineal tears, and urinary and fecal incontinence.

Primary Outcome Measures

Name	Time	Method
length of the second stage of labor	up to 1 week after labor	measure by time (min/hour)

Secondary Outcome Measures

Name	Time	Method
Perineal tears	up to 1 week after labor	Number of Participants with Perineal tears, specifically OASIS - obstetric anal sphincter Number of Participants with injuries
Fear of birth questionnaire	Baseline, a week later , 1 week after labor and two months after labor	6-36, higher score mean worse outcome.
Mode of delivery	up to 1 week after labor	Number of Participants with spontaneous vaginal or operative delivery (operative assisted - vacuum-assisted, forceps assisted, cesarean delivery)
Urinary and fecal incontinence	up to 1 week after labor, and 2 month after labor.	Number of Participants with Urinary and/ or fecal incontinence

Trial Locations

Locations (1)

Noa Ben Ami; 🇮🇱 Ariel, Israel