An interventional study of Visual Biofeedback using self operated home ultrasound device and Visual Biofeedback using ultrasound at hospital in Obstetric Labor Complications and Obstetric Trauma, sponsored by Rabin Medical Center. Recruiting at 1 site in Israel. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Rabin Medical Center · Not applicable, Interventional, and Prevention
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.
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:
88 studies on the registry are indexed under Obstetric Labor Complications; 24 are open to participants now.
This study's planned enrollment of 159 is close to the median of 159 across 63 interventional studies indexed under Obstetric Labor Complications.
Browse Obstetric Labor Complications studies →Rabin Medical Center is the lead sponsor of 393 studies on the registry; 30 are open to participants now.
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Exclusion Criteria:
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Sonographic fetal weight and biophysical profiles will be done at the hospital clinic. A single ultrasound biofeedback session using transperineal ultrasound (TPU) will guide maternal pushing. The process includes (a) Ultrasound assessing fetal head descent with the screen facing the provider, measuring the angle of progression (AOP); (b) Explaining anatomical landmarks to the patient; (c) Repeat AOP measurement with the screen facing the patient for biofeedback; (d) Reassess with the screen turned away. Participants will receive a handheld home ultrasound device and will learn to perform self-biofeedback at home, ideally twice a week until delivery. Session records will be sent electronically to the sonographer for assessment and feedback. All groups will complete questionnaires three times: (1) baseline, (2) approximately one week later (after home biofeedback training), and (3) six weeks postpartum.
Device: Visual Biofeedback using self operated home ultrasound device
A sonographic fetal weight estimate and biophysical profile will occur at the hospital clinic for all patients. A single ultrasound-based biofeedback session will employ TPU for maternal pushing guidance. This process involves (a) Assessing fetal head descent with ultrasound to measure the angle of progression (AOP) during rest and pushing; (b) Explaining anatomical landmarks to the patient; (c) Repeating the AOP measurement as biofeedback; (d) Reassessing with the screen turned away. Participants will complete questionnaires three times: (1) baseline, (2) two weeks later, and (3) six to eight weeks postpartum.
Device: Visual Biofeedback using ultrasound at hospital
A sonographic estimated fetal weight and biophysical profile will be performed in the hospital. The participant will fill in questionnaires at three time points: (1) at baseline, before the ultrasound examination; (2) about two weeks later (i.e., after completing the self-operated visual biofeedback training at home, or at an equivalent time for the other two groups); (3) six to eight weeks postpartum.
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.
The length of the second stage of labour
measure by time
Time frame: up to 1 week after labor
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
OASIS - obstetrical anal sphincter injuries
Number of Participants with severe perineal tear
Time frame: up to 1 week after labor
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
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
Fear of childbirth
Number of participants who demonstrated fear of childbirth according to questionnaires
Time frame: up to 4 weeks before labor
PTSS (post traumatic stress symptoms)
Number of participants who demonstrated PTSS according to questionnaires
Time frame: up to 3 months post partum
Plan to share: No — All collected data will be securely stored and used solely for research, analysis, and reporting within the scope of this study. Any results or findings that we may share with the scientific community or the public will be presented in aggregated, de-identified, and anonymized formats to protect participant privacy. Our primary focus is to use the gathered data for research purposes, and we do not anticipate sharing individual participant data beyond the confines of this study's objectives.
Started Dec 2023 (actual). Primary completion is estimated for Sep 2027, 45 months after the start.
Of 27 interventional studies with no phase under Obstetric Labor Complications, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 51. This study's planned 45 months is above that.
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