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

A

Ariel University

Status

Completed

Conditions

Pregnancy Related
Delivery Complication

Treatments

Behavioral: Pre-labor ultrasound as a visual biofeedback device for maternal pushing education and pelvic floor training

Study type

Interventional

Funder types

Other

Identifiers

NCT05258786
AU-HEA-NBA-20211128 Pre_labor

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

120 participants in 3 patient groups

Intervention group
Experimental group
Description:
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.
Treatment:
Behavioral: Pre-labor ultrasound as a visual biofeedback device for maternal pushing education and pelvic floor training
Control group
No Intervention group
Description:
A pelvic floor physiotherapist will provide the participants with a verbal explanation of how to contract pelvic floor muscles. without ultrasound.
Standard care
No Intervention group
Description:
Questionnaires only at four timeline points - before delivery at recruitment (T0), a week later (T2), immediately postpartum (T3), and two months postpartum (T4)

Trial contacts and locations

1

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Central trial contact

Sarit Resnik Ruff, BPT; Noa Ben Ami, PhD

Data sourced from clinicaltrials.gov

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