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NCT Number: NCT06049784

Prelabor Visual Biofeedback by a Self-operated Ultrasound Device

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The primary goal of this study is to evaluate the effectiveness of visual biofeedback prior to labor, which involves a single session in the hospital combined with a self-administered home ultrasound to train mothers on pushing techniques during the second stage of labor. The approach integrates a one-time pre-labor training session at the clinic, as previously explored by Youssef et al. (2021), with a continued two-week intervention carried out by the participants at home. This method is anticipated to enhance the benefits noted in prior research. The study will examine the impact of this training intervention and then collect comprehensive data on both obstetric and psychological outcomes, which will include medical records and self-report questionnaires completed by the participants before and after childbirth. The intervention seeks to mitigate maternal and neonatal obstetric complications and other adverse outcomes. The specific objectives of this study are:

  • to decrease the duration of the second stage of labor, minimize medical interventions during labor, and lessen birth-related complications;
  • to alleviate prenatal fear of childbirth and bolster confidence in the birthing process;
  • to enhance perceived personal control during labor and increase satisfaction with the birthing experience;
  • to improve maternal-infant bonding and reduce incidences of post-traumatic stress symptoms;
  • to explore participants' experiences with the at-home, self-managed intervention and its effectiveness through semi-structured, in-depth interviews with a subset of the participants involved in this study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Nuliparity
  • Singleton pregnancy
  • Planned for vaginal delivery
  • Low risk pregnancy
  • Ability to fulfill a questionnaire

Exclusion criteria

  • Multifetal gestation
  • Contraindications for vaginal delivery (Placenta previa, Breech presentation etc.)
  • High risk pregnancy

Treatment and study plan

Visual Biofeedback using self operated home ultrasound device

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.

Visual Biofeedback using ultrasound at hospital

Device

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

Primary outcomes

  1. The length of the second stage of labour

    Time frame: up to 1 week after labor

    measure by time

Secondary outcomes

  1. Mode of delivery

    Time frame: up to 1 week after labor

    Number of participants with spontaneous vaginal delivery or operative delivery (operative assisted - vacuum assisted/forceps, cesarean delivery)

  2. OASIS - obstetrical anal sphincter injuries

    Time frame: up to 1 week after labor

    Number of Participants with severe perineal tear

  3. Low neonatal APGAR score

    Time frame: up to 1 week after labor

    number of participants who delivered a neonate with APGAR score < 7 at 5 minutes after birth

  4. NICU (neonatal intensive care unit) hospitalization

    Time frame: up to 1 week after labor

    number of participants who delivered a neonate transferred to the NICU

  5. Fear of childbirth

    Time frame: up to 4 weeks before labor

    Number of participants who demonstrated fear of childbirth according to questionnaires

  6. PTSS (post traumatic stress symptoms)

    Time frame: up to 3 months post partum

    Number of participants who demonstrated PTSS according to questionnaires

Study contacts

Contact information is provided by the study sponsor or research team.

Sharon Perlman, MD

CONTACT

[email protected]

972547481097

Shira Waks

CONTACT

[email protected]

972528557212

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Collaborators

  • Tel Aviv University

Registry information

Official study title

Prelabor Maternal Pushing Training Using Visual Biofeedback by a Self-operated Ultrasound Device

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2023
Registry last updated
May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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