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

NCT05258786 | Completed

• 1 other identifier: AU-HEA-NBA-20211128 Pre_labor
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Delivery Complication

Keywords

pre-labor education; biofeedback; ultrasound; vaginal delivery; fear of childbirth

Outcome Measures

Primary Outcomes (1)

• length of the second stage of labor

  measure by time (min/hour)

  up to 1 week after labor

Secondary Outcomes (4)

• Mode of delivery

  up to 1 week after labor

• Perineal tears

  up to 1 week after labor

• Urinary and fecal incontinence

  up to 1 week after labor, and 2 month after labor.

• Fear of birth questionnaire

  Baseline, a week later , 1 week after labor and two months after labor

Study Arms (3)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Questionnaires only at four timeline points - before delivery at recruitment (T0), a week later (T2), immediately postpartum (T3), and two months postpartum (T4)

Interventions

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

1. 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. 2. The provider will turn the screen to the patient and explain the anatomical landmarks: bladder, fetal head, birth canal direction. 3. 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. 4. Finally, the provider will turn the screen again from the patient and repeat the first stage.

Intervention group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• pregnant nullipara women with a low-risk pregnancy who are planned for vaginal delivery. The biofeedback will occur at 36-42 gestational weeks.

You may not qualify if:

• an inability to fill questionaries due to communication issues or cesarean section performed due to major obstetrical events.

Sponsors & Collaborators

• Ariel University: lead

Study Sites (1)

Noa Ben Ami

Ariel, 40700, Israel

Location

Study Officials

• Noa Ben Ami, PhD

  Ariel University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will collect the data from the files without knowing the participant's groups (intervention/control/standard care)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 28, 2022
• Study Start: February 18, 2022
• Primary Completion: January 28, 2024
• Study Completion: January 28, 2024
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)