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| Name | Class |
|---|---|
| Tel Aviv University | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 trans-perineal 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, learning to perform self-biofeedback at home, ideally twice a week, up to 4 times. Session records will be sent electronically to the sonographer for assessment and feedback. All groups will complete questionnaires three times: (1) baseline, (2) about two weeks later (after home biofeedback training), and (3) six to eight weeks postpartum. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The length of the second stage of labour | measure by time | up to 1 week after labor |
| Measure | Description | Time Frame |
|---|---|---|
| Mode of delivery | Number of participants with spontaneous vaginal delivery or operative delivery (operative assisted - vacuum assisted/forceps, cesarean delivery) | up to 1 week after labor |
| OASIS - obstetrical anal sphincter injuries |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shira Waks | Contact | 972528557212 | Shiraw@clalit.org.il | |
| Sharon Perlman, MD | Contact | 972547481097 | drsharonperlman@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sharon Perlman, MD | Rabin Medical Center, affiliated to the Tel Aviv University, Tel Aviv, Israel | Principal Investigator |
| Natav Hendin, MD | Rabin Medical Center, affiliated to the Tel Aviv University, Tel Aviv, Israel |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center | Recruiting | Petah Tikva | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29155474 | Background | 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. | |
| 29532533 | Background | Bellussi 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. |
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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.
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| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Parallel assignment Randomised Control Trial
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The outcome assessor will collect the data from the files without knowing the participants' group assignment.
| Visual Biofeedback using ultrasound at hospital | Device | A single ultrasound biofeedback session using Transperineal Ultrasound will guide maternal pushing. |
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Number of Participants with severe perineal tear
| 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 | up to 1 week after labor |
| NICU (neonatal intensive care unit) hospitalization | number of participants who delivered a neonate transferred to the NICU | up to 1 week after labor |
| Fear of childbirth | Number of participants who demonstrated fear of childbirth according to questionnaires | up to 4 weeks before labor |
| PTSS (post traumatic stress symptoms) | Number of participants who demonstrated PTSS according to questionnaires | up to 3 months post partum |
| 33729014 | Background | Hadar 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. |
| 32105133 | Background | Schlesinger 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. |