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Completed

NCT Number: NCT05258786

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

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.

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Key information

Conditions

Pregnancy Related Delivery Complication

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Noa Ben Ami

Ariel, 40700, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Behavioral
  • 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.

Primary outcomes

  1. length of the second stage of labor

    Time frame: up to 1 week after labor

    measure by time (min/hour)

Secondary outcomes

  1. Mode of delivery

    Time frame: up to 1 week after labor

    Number of Participants with spontaneous vaginal or operative delivery (operative assisted - vacuum-assisted, forceps assisted, cesarean delivery)

  2. Perineal tears

    Time frame: up to 1 week after labor

    Number of Participants with Perineal tears, specifically OASIS - obstetric anal sphincter Number of Participants with injuries

  3. Urinary and fecal incontinence

    Time frame: up to 1 week after labor, and 2 month after labor.

    Number of Participants with Urinary and/ or fecal incontinence

  4. Fear of birth questionnaire

    Time frame: Baseline, a week later , 1 week after labor and two months after labor

    6-36, higher score mean worse outcome.

Sponsors and collaborators

Lead sponsor

Ariel University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 28, 2022
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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