Prelabor Visual Biofeedback by a Self-operated Ultrasound Device

Summary

A substantial number of women report fear of childbirth and negative birth experiences. The objective of the study is to assess the efficacy of visual biofeedback before labor using a self-operated home ultrasound for maternal pushing training, which is expected to reduce fear of childbirth, increase perceived control during birth, prevent prolonged labor and the ensuing maternal and neonatal negative adverse outcomes, and prevent maternal post-traumatic stress symptoms. Intrapartum visual biofeedback provided by obstetricians during the second stage of labor has been shown to increase pushing efficiency and improve maternal obstetric and psychological outcomes. Previously, visual biofeedback has been implemented only in an in-hospital setting and, with one known exception, only during labor. A Mobile Self-Operated Home Ultrasound System has been reported as a feasible and reliable tool for obstetrical ultrasound. A randomized controlled trial will be conducted with three study groups of pregnant women (37 weeks of gestation and above): (1) Obstetrical ultrasound+visual biofeedback in-hospital and at home using self-operated ultrasound; (2) Obstetrical ultrasound+visual biofeedback in-hospital; (3) Obstetrical ultrasound only. Visual biofeedback by ultrasound will be performed by transperineal ultrasound, enabling the future mother to visualize the descent of the fetal head within the birth canal in response to her pushing effort. Follow-up will be conducted approximately one week later and at six weeks postpartum. Positive results following the application of biofeedback by self-operated home ultrasound may change the paradigm for pre-labor sonographic education. Self-operated home ultrasound will also enable more comprehensive pre-labor ultrasound-based education and hopefully reduce adverse physical and psychological outcomes following childbirth.

Conditions

• Obstetric Labor Complications
• Obstetric Trauma

Interventions

DEVICE

Visual Biofeedback using self operated home ultrasound device

participants will receive a handheld home ultrasound device, learning to perform self-biofeedback at home. Session records will be sent electronically to the sonographer for assessment and feedback.

DEVICE

Visual Biofeedback using ultrasound at hospital

A single ultrasound biofeedback session using Transperineal Ultrasound will guide maternal pushing.

Sponsors & Collaborators

• Tel Aviv University

  collaborator OTHER

• Rabin Medical Center

  lead OTHER

Principal Investigators

• Sharon Perlman, MD · Rabin Medical Center, affiliated to the Tel Aviv University, Tel Aviv, Israel

• Natav Hendin, MD · Rabin Medical Center, affiliated to the Tel Aviv University, Tel Aviv, Israel

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-12-31

Primary Completion

2027-09-30

Completion

2028-12-31

Countries

• Israel

Study Locations