Obstetric Labor Complications Clinical Trial
Official title:
Prelabor Maternal Pushing Training Using Visual Biofeedback by a Self-operated Ultrasound Device
Verified date | May 2024 |
Source | Rabin Medical Center |
Contact | Shira Waks |
Phone | 972528557212 |
Shiraw[@]clalit.org.il | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 261 |
Est. completion date | December 2026 |
Est. primary completion date | September 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Nuliparity - Singleton pregnancy - Planned for vaginal delivery - Low risk pregnancy - Ability to fulfill a questionnaire Exclusion Criteria: - Multifetal gestation - Contraindications for vaginal delivery (Placenta previa, Breech presentation etc.) - High risk pregnancy |
Country | Name | City | State |
---|---|---|---|
Israel | Rabin Medical Center | Petach Tikva |
Lead Sponsor | Collaborator |
---|---|
Rabin Medical Center | Tel Aviv University |
Israel,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The length of the second stage of labour | measure by time | up to 1 week after labor | |
Secondary | 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 | |
Secondary | OASIS - obstetrical anal sphincter injuries | Number of Participants with severe perineal tear | up to 1 week after labor | |
Secondary | 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 | |
Secondary | NICU (neonatal intensive care unit) hospitalization | number of participants who delivered a neonate transferred to the NICU | up to 1 week after labor | |
Secondary | Fear of childbirth | Number of participants who demonstrated fear of childbirth according to questionnaires | up to 4 weeks before labor | |
Secondary | PTSS (post traumatic stress symptoms) | Number of participants who demonstrated PTSS according to questionnaires | up to 3 months post partum |
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