Prelabor Visual Biofeedback by a Self-operated Ultrasound Device
Study Details
Study Description
Brief Summary
A substantial number of women report fear of childbirth and negative birth experiences. Our objective is to assess the efficacy of visual biofeedback before labor by 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. Visual biofeedback has been performed only in an in-hospital setting and, with one exception we are aware of, only during labor. A Mobile Self-Operated Home Ultrasound System was 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; (1) 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.
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N/A |
Detailed Description
The main objective of the present study is to assess the efficacy of visual biofeedback before labor by combining a single in-hospital session with a self-operated home ultrasound to train maternal pushing during the second stage of labor. The study combines the advantage of pre-labor training women in a single session at the clinic, as studied previously (Youssef et al., 2021), with an extended intervention and self-performed procedure at home over two weeks. This intervention is expected to augment the advantages previously described in the literature. The proposed study will assess the advantages of this intervention during training, followed by collecting detailed information on obstetric and psychological outcomes from medical records and using self-report questionnaires filled in by the participants before birth and postpartum. This intervention aims to prevent maternal and neonatal obstetric complications and adverse outcomes. Specifically, we aim:
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to shorten the length of the second stage, reduce the number of medical interventions during labor, and reduce complications during birth;
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to reduce prenatal fear of childbirth and increase confidence in the ability to give birth;
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to increase perceived personal control during labor and birth satisfaction;
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to improve maternal-infant bonding and reduce the rate of post-traumatic stress symptoms.
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to understand women's experience of the self-operated at-home intervention and its contribution through semi-structured in-depth interviews with a subsample of the women who participated in this study condition.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Visual Biofeedback using self operated home ultrasound device 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. |
Device: Visual Biofeedback using self operated home ultrasound 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.
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| Active Comparator: Visual biofeedback at the Hospital 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 single ultrasound biofeedback session using Transperineal Ultrasound will guide maternal pushing.
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| No Intervention: Control / Standard care - Obstetrical ultrasound only 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. |
Outcome Measures
Primary Outcome Measures
- The length of the second stage of labour [through study completion, an average of 6 months]
Length of second stage of labor in minutes according to data retrieved from computerised medical file
Secondary Outcome Measures
- Mode of delivery [through study completion, an average of 6 months]
Spontaneous vaginal delivery or assisted operative delivery according to data retrieved from computerised medical file
- OASIS - obstetrical anal sphincter injuries [through study completion, an average of 6 months]
according to data retrieved from computerised medical file
- Low neonatal APGAR score [through study completion, an average of 6 months]
according to data retrieved from computerised medical file
- NICU (neonatal intensive care unit) hospitalization [through study completion, an average of 6 months]
according to data retrieved from computerised medical file
- Fear of childbirth [through study completion, an average of 6 months]
according to questionaires
- Anticipated self-control over various aspects of childbirth [through study completion, an average of 6 months]
according to questionaires
- PTSS (post traumatic tree symptoms) [through study completion, an average of 6 months]
according to questionaires
Eligibility Criteria
Criteria
Inclusion Criteria:
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Nuliparity
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Singleton pregnancy
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Planned for vaginal delivery
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Low risk pregnancy
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Ability to fulfill a questionnaire
Exclusion Criteria:
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Multifetal gestation
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Contraindications for vaginal delivery (Placenta previa, Breech presentation etc.)
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High risk pregnancy
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Rabin Medical Center
- Tel Aviv University
Investigators
- Principal Investigator: Sharon Perlman, MD, Rabin Medical Center, affiliated to the Tel Aviv University, Tel Aviv, Israel
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- RMC-0400-21