Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT06049784

Prelabor Visual Biofeedback by a Self-operated Ultrasound Device

Led by Rabin Medical Center · Updated on 2024-05-06

261

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

Sponsors

R

Rabin Medical Center

Lead Sponsor

T

Tel Aviv University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 (37-39 weeks of gestation): (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 two weeks later and at six weeks postpartum. Positive results following the application of biofeedback by self-operated home ultrasound may change the paradigm for pre-labour 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

Official Title

Prelabor Visual Biofeedback by a Self-operated Ultrasound Device

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • First pregnancy (nuliparity)
  • Single baby pregnancy
  • Planned vaginal delivery
  • Low risk pregnancy
  • Able to complete questionnaires
Not Eligible

You will not qualify if you...

  • Multiple babies (multifetal gestation)
  • Conditions preventing vaginal delivery (e.g., placenta previa, breech presentation)
  • High risk pregnancy

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Trial Site Locations

Total: 1 location

1

Rabin Medical Center

Petah Tikva, Israel

Actively Recruiting

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Research Team

S

Shira Waks

CONTACT

S

Sharon Perlman, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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