Prelabor Visual Biofeedback by a Self-operated Ultrasound Device

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorRabin Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Nuliparity

Singleton pregnancy

Planned for vaginal delivery

Low risk pregnancy

Disqualifiers

Multifetal gestation

Contraindications for vaginal delivery (Placenta previa, Breech presentation etc.)

High risk pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

159 Participants
are divided into 3 treatment groups
Group A: Visual Biofeedback using self operated home ultrasound deviceExperimental treatment 1 intervention
Group B: Visual biofeedback at the HospitalActive comparator 1 intervention
Group C: Control / Standard care - Obstetrical ultrasound onlyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

The length of the second stage of labour

measure by time

Time frame
up to 1 week after labor

Secondary outcomes

1

Mode of delivery

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

Time frame
up to 1 week after labor
2

OASIS - obstetrical anal sphincter injuries

Number of Participants with severe perineal tear

Time frame
up to 1 week after labor
3

Low neonatal APGAR score

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

Time frame
up to 1 week after labor
4

NICU (neonatal intensive care unit) hospitalization

number of participants who delivered a neonate transferred to the NICU

Time frame
up to 1 week after labor

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rabin Medical Center

Lead sponsor

Tel Aviv University

Collaborator