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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Visual Biofeedback using self operated home ultrasound device
Deviceparticipants 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
DeviceA single ultrasound biofeedback session using Transperineal Ultrasound will guide maternal pushing.
Treatment groups
Trial outcomes
Primary outcomes
The length of the second stage of labour
measure by time
Secondary outcomes
Mode of delivery
Number of participants with spontaneous vaginal delivery or operative delivery (operative assisted - vacuum assisted/forceps, cesarean delivery)
OASIS - obstetrical anal sphincter injuries
Number of Participants with severe perineal tear
Low neonatal APGAR score
number of participants who delivered a neonate with APGAR score \< 7 at 5 minutes after birth
NICU (neonatal intensive care unit) hospitalization
number of participants who delivered a neonate transferred to the NICU
Sponsors and contacts
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Rabin Medical Center
Lead sponsor
Tel Aviv University
Collaborator