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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ariel, Israel, 40700
    • Noa Ben Ami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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.	Behavioral: Pre-labor ultrasound as a visual biofeedback device for maternal pushing education and pelvic floor training; Ultrasound examination with the screen turned to the provider will assess the bladder movements at rest and during contraction of the pelvic floor and fetal head descent at rest and during pushing.; The provider will turn the screen to the patient and explain the anatomical landmarks: bladder, fetal head, birth canal direction.; A repeat of the first stage (1) with the screen turned to the patient: the biofeedback process. Bladder displacement will serve as a marker of pelvic floor contraction, and the delta in the progression angle will serve as a marker for effective pushing.; Finally, the provider will turn the screen again from the patient and repeat the first stage.
No Intervention: Control group; A pelvic floor physiotherapist will provide the participants with a verbal explanation of how to contract pelvic floor muscles. without ultrasound.
No Intervention: Standard care; Questionnaires only at four timeline points - before delivery at recruitment (T0), a week later (T2), immediately postpartum (T3), and two months postpartum (T4)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of the second stage of labor	measure by time (min/hour)	up to 1 week after labor

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ariel University
• Investigators: Principal Investigator: Noa Ben Ami, PhD, Ariel University

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2022
• Primary Completion (Actual): January 28, 2024
• Study Completion (Actual): January 28, 2024

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: biofeedback; ultrasound; fear of childbirth; vaginal delivery; pre-labor education
• Other Study ID Numbers: AU-HEA-NBA-20211128 Pre_labor

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No