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

Sponsor
Ariel University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05258786
Collaborator
(none)
150
1
3
23.4
6.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Pre-labor ultrasound as a visual biofeedback device for maternal pushing education and pelvic floor training
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled studyRandomized controlled study
Masking:
Single (Outcomes Assessor)
Masking Description:
The outcomes assessor will collect the data from the files without knowing the participant's groups (intervention/control/standard care)
Primary Purpose:
Prevention
Official Title:
Pre-labor Ultrasound as a Visual Biofeedback Device for Maternal Pushing Education and Pelvic Floor Training - a Randomized Control Trial
Actual Study Start Date :
Feb 18, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.

No Intervention: Control group

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

No Intervention: 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)

Outcome Measures

Primary Outcome Measures

  1. length of the second stage of labor [up to 1 week after labor]

    measure by time (min/hour)

Secondary Outcome Measures

  1. Mode of delivery [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 [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 [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 [Baseline, a week later , 1 week after labor and two months after labor]

    6-36, higher score mean worse outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Noa Ben Ami Ariel Israel 40700

Sponsors and Collaborators

  • Ariel University

Investigators

  • Principal Investigator: Noa Ben Ami, PhD, Ariel University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ariel University
ClinicalTrials.gov Identifier:
NCT05258786
Other Study ID Numbers:
  • AU-HEA-NBA-20211128 Pre_labor
First Posted:
Feb 28, 2022
Last Update Posted:
Jul 20, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ariel University

Study Results

No Results Posted as of Jul 20, 2022