Obstetric Labor ComplicationsNCT06049784
Prelabor Visual Biofeedback by a Self-operated Ultrasound Device
A study testing Visual Biofeedback using self operated home ultrasound device and Visual Biofeedback using ultrasound at hospital in people with Obstetric Labor Complications and Obstetric Trauma, run by Rabin Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric Labor Complications, Obstetric Trauma
- What is being tested?
- Visual Biofeedback using self operated home ultrasound device and Visual Biofeedback using ultrasound at hospital
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteIsrael
- Study dates
- 31 Dec 2023to Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Nuliparity
- Singleton pregnancy
- Planned for vaginal delivery
- Low risk pregnancy
- Ability to fulfill a questionnaire
Who cannot join
- Multifetal gestation
- Contraindications for vaginal delivery (Placenta previa, Breech presentation etc.)
- High risk pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center
Petah Tikva
Sharon Perlman, Prof, 972547481097, drsharonperlman@gmail.com
Natav Hendin, MD, 972546899506, Hendinatav@gmail.com
About this study
Official title: Prelabor Maternal Pushing Training Using Visual Biofeedback by a Self-operated Ultrasound Device
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.
Read the 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:
- to decrease the duration of the second stage of labor, minimize medical interventions during labor, and lessen birth-related complications;
- to alleviate prenatal fear of childbirth and bolster confidence in the birthing process;
- to enhance perceived personal control during labor and increase satisfaction with the birthing experience;
- to improve maternal-infant bonding and reduce incidences of post-traumatic stress symptoms;
- 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.
- Conditions
- Obstetric Labor Complications, Obstetric Trauma
- Being tested
- Visual Biofeedback using self operated home ultrasound device, Visual Biofeedback using ultrasound at hospital
- Keywords
- Visual Biofeedback, Self Operated Ultrasound device, Second stage of labor, Trans Perineal Ultrasound
- Medical subject headings
- Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Biofeedback using self operated home ultrasound deviceDevice
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 hospitalDevice
A single ultrasound biofeedback session using Transperineal Ultrasound will guide maternal pushing.
| Study group | Role | What they receive |
|---|---|---|
| Visual Biofeedback using self operated home ultrasound device | Experimental | 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. Receives: Device: Visual Biofeedback using self operated home ultrasound device |
| Visual biofeedback at the Hospital | Active comparator | 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. Receives: Device: Visual Biofeedback using ultrasound at hospital |
| Control / Standard care - Obstetrical ultrasound only | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The length of the second stage of labour
measure by time
Measured: up to 1 week after labor
Secondary outcomes (6)
Mode of delivery
Number of participants with spontaneous vaginal delivery or operative delivery (operative assisted - vacuum assisted/forceps, cesarean delivery)
Measured: up to 1 week after labor
OASIS - obstetrical anal sphincter injuries
Number of Participants with severe perineal tear
Measured: 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
Measured: up to 1 week after labor
NICU (neonatal intensive care unit) hospitalization
number of participants who delivered a neonate transferred to the NICU
Measured: up to 1 week after labor
Fear of childbirth
Number of participants who demonstrated fear of childbirth according to questionnaires
Measured: up to 4 weeks before labor
PTSS (post traumatic stress symptoms)
Number of participants who demonstrated PTSS according to questionnaires
Measured: up to 3 months post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start31 Dec 2023
- Primary completionSep 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obstetric Labor ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment Randomised Control Trial
- Masking
- None (open label)
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv University
- Responsible party
- Principal investigator, Sharon Perlman, Rabin Medical Center
- Investigators
- Sharon Perlman, MD, Principal investigator, Rabin Medical Center, affiliated to the Tel Aviv University, Tel Aviv, IsraelNatav Hendin, MD, Principal investigator, Rabin Medical Center, affiliated to the Tel Aviv University, Tel Aviv, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049784
- Sponsor's protocol ID
- RMC-0400-21
- Status last verified
- Aug 2025
- First submitted
- 1 Sep 2023
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Gilboa Y, Frenkel TI, Schlesinger Y, Rousseau S, Hamiel D, Achiron R, Perlman S. Visual biofeedback using transperineal ultrasound in second stage of labor. Ultrasound Obstet Gynecol. 2018 Jul;52(1):91-96. doi: 10.1002/uog.18962. Epub 2018 May 29.
PubMed 29155474Bellussi F, Alcamisi L, Guizzardi G, Parma D, Pilu G. Traditionally vs sonographically coached pushing in second stage of labor: a pilot randomized controlled trial. Ultrasound Obstet Gynecol. 2018 Jul;52(1):87-90. doi: 10.1002/uog.19044. Epub 2018 May 30.
PubMed 29532533Hadar E, Wolff L, Tenenbaum-Gavish K, Eisner M, Shmueli A, Barbash-Hazan S, Bergel R, Shmuel E, Houri O, Dollinger S, Brzezinski-Sinai NA, Sukenik S, Pardo A, Navon I, Wilk Y, Zafrir-Danieli H, Wiznitzer A. Mobile Self-Operated Home Ultrasound System for Remote Fetal Assessment During Pregnancy. Telemed J E Health. 2022 Jan;28(1):93-101. doi: 10.1089/tmj.2020.0541. Epub 2021 Mar 15.
PubMed 33729014Schlesinger Y, Hamiel D, Rousseau S, Perlman S, Gilboa Y, Achiron R, Frenkel TI. Preventing risk for posttraumatic stress following childbirth: Visual biofeedback during childbirth increases maternal connectedness to her newborn thereby preventing risk for posttraumatic stress following childbirth. Psychol Trauma. 2022 Sep;14(6):1057-1065. doi: 10.1037/tra0000558. Epub 2020 Feb 27.
PubMed 32105133