Rabin Medical Center
Petah Tikva, Israel
Location status: Recruiting
Location contact
Natav Hendin, MD
CONTACT
Sharon Perlman, Prof
CONTACT
NCT Number: NCT06049784
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Petah Tikva, Israel
Location status: Recruiting
Natav Hendin, MD
CONTACT
Sharon Perlman, Prof
CONTACT
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
A single ultrasound biofeedback session using Transperineal Ultrasound will guide maternal pushing.
Time frame: up to 1 week after labor
measure by time
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)
Time frame: up to 1 week after labor
Number of Participants with severe perineal tear
Time frame: up to 1 week after labor
number of participants who delivered a neonate with APGAR score < 7 at 5 minutes after birth
Time frame: up to 1 week after labor
number of participants who delivered a neonate transferred to the NICU
Time frame: up to 4 weeks before labor
Number of participants who demonstrated fear of childbirth according to questionnaires
Time frame: up to 3 months post partum
Number of participants who demonstrated PTSS according to questionnaires
Contact information is provided by the study sponsor or research team.
Sharon Perlman, MD
CONTACT
Shira Waks
CONTACT
Rabin Medical Center
Other
Prelabor Maternal Pushing Training Using Visual Biofeedback by a Self-operated Ultrasound Device
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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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