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Prelabor Visual Biofeedback by a Self-operated Ultrasound Device

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06049784
Enrollment
159
Registered
2023-09-22
Start date
2023-12-31
Completion date
2028-12-01
Last updated
2026-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstetric Labor Complications, Obstetric Trauma

Keywords

Visual Biofeedback, Self Operated Ultrasound device, Second stage of labor, Trans Perineal Ultrasound

Brief 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.

Detailed description

The primary goal of this study is to evaluate the effectiveness of visual biofeedback prior to labor, which involves a single hospital session combined with a self-administered home ultrasound to train mothers in 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 intervention conducted by participants at home until delivery. This method is anticipated to enhance the benefits noted in prior research. The study will examine the impact of this training intervention and collect comprehensive data on obstetric and psychological outcomes, including medical records and self-report questionnaires completed by 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: 1. to decrease the duration of the second stage of labor, minimize medical interventions during labor, and lessen birth-related complications; 2. to alleviate prenatal fear of childbirth and bolster confidence in the birthing process; 3. to enhance perceived personal control during labor and increase satisfaction with the birthing experience; 4. to improve maternal-infant bonding and reduce incidences of post-traumatic stress symptoms; 5. 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.

Interventions

DEVICEVisual 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.

DEVICEVisual Biofeedback using ultrasound at hospital

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

Sponsors

Rabin Medical Center
Lead SponsorOTHER
Tel Aviv University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Masking description

The outcome assessor will collect the data from the files without knowing the participants' group assignment.

Intervention model description

Parallel assignment Randomised Control Trial

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The length of the second stage of labourup to 1 week after labormeasure by time

Secondary

MeasureTime frameDescription
Mode of deliveryup to 1 week after laborNumber of participants with spontaneous vaginal delivery or operative delivery (operative assisted - vacuum assisted/forceps, cesarean delivery)
OASIS - obstetrical anal sphincter injuriesup to 1 week after laborNumber of Participants with severe perineal tear
Low neonatal APGAR scoreup to 1 week after labornumber of participants who delivered a neonate with APGAR score \< 7 at 5 minutes after birth
NICU (neonatal intensive care unit) hospitalizationup to 1 week after labornumber of participants who delivered a neonate transferred to the NICU
Fear of childbirthup to 4 weeks before laborNumber of participants who demonstrated fear of childbirth according to questionnaires
PTSS (post traumatic stress symptoms)up to 3 months post partumNumber of participants who demonstrated PTSS according to questionnaires

Countries

Israel

Contacts

CONTACTShira Waks
Shiraw@clalit.org.il972528557212
CONTACTSharon Perlman, MD
drsharonperlman@gmail.com972547481097
PRINCIPAL_INVESTIGATORSharon Perlman, MD

Rabin Medical Center, affiliated to the Tel Aviv University, Tel Aviv, Israel

PRINCIPAL_INVESTIGATORNatav Hendin, MD

Rabin Medical Center, affiliated to the Tel Aviv University, Tel Aviv, Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 19, 2026