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Prelabor Visual Biofeedback by a Self-operated Ultrasound Device

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Sep 2026 → Sep 2027
Enrollment reduced 39% 261 → 159 participants
See other at-risk trials from Rabin Medical Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Sep 2026 to Sep 2027
    • Enrollment reduced: 261 → 159 participants
    • Study completion pushed from Dec 2026 to Dec 2028
    • Study description shortened, about 8 words
    v3
  2. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Sep 2023 to Dec 31, 2023
    • Study sites: 0 to 1
    • Secondary endpoints: 7 to 6
    • Study description expanded, about 1 word
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06049784
Lead Sponsor Rabin Medical Center
Collaborators: Tel Aviv University
Conditions
(from sponsor)
Obstetric Labor Complications, Obstetric Trauma
Related terms Obstetric Labor Complications
Enrollment 159 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov