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

NCT ID: NCT05258786

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-18
• Study Completion Date: 2024-01-28

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.

Conditions

Pregnancy Related; Delivery Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Control group

A pelvic floor physiotherapist will provide the participants with a verbal explanation of how to contract pelvic floor muscles. without ultrasound.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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 Type: BEHAVIORAL

Eligibility Criteria

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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ariel University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Noa Ben Ami, PhD

Role: PRINCIPAL_INVESTIGATOR

Ariel University

Locations

Noa Ben Ami

Ariel, , Israel

Countries

Israel

Other Identifiers

AU-HEA-NBA-20211128 Pre_labor

Identifier Type: -

Identifier Source: org_study_id