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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05258786
• Other study ID #: AU-HEA-NBA-20211128 Pre_labor
• Status: Completed
• Phase: N/A
• Start date: February 18, 2022
• Est. completion date: January 28, 2024

Study information

• Verified date: January 2024
• Source: Ariel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 28, 2024
• Est. primary completion date: January 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Delivery Complication
• Pregnancy Related

Intervention

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.

Locations

Country	Name	City	State
Israel	Noa Ben Ami	Ariel

Sponsors (1)

Lead Sponsor	Collaborator
Ariel University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of the second stage of labor	measure by time (min/hour)	up to 1 week after labor
Secondary	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
Secondary	Perineal tears	Number of Participants with Perineal tears, specifically OASIS - obstetric anal sphincter Number of Participants with injuries	up to 1 week after labor
Secondary	Urinary and fecal incontinence	Number of Participants with Urinary and/ or fecal incontinence	up to 1 week after labor, and 2 month after labor.
Secondary	Fear of birth questionnaire	6-36, higher score mean worse outcome.	Baseline, a week later , 1 week after labor and two months after labor