Prelabor Visual Biofeedback by a Self-operated Ultrasound Device

Obstetric Labor Complications Clinical Trial

Official title: Prelabor Maternal Pushing Training Using Visual Biofeedback by a Self-operated Ultrasound Device

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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: 1. to shorten the length of the second stage, reduce the number of medical interventions during labor, and reduce complications during birth; 2. to reduce prenatal fear of childbirth and increase confidence in the ability to give birth; 3. to increase perceived personal control during labor and birth satisfaction; 4. to improve maternal-infant bonding and reduce the rate of post-traumatic stress symptoms. 5. 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. ;

Related Conditions & MeSH terms

• Obstetric Labor Complications
• Obstetric Trauma

• NCT number: NCT06049784
• Study type: Interventional
• Source: Rabin Medical Center
• Contact: Shira Waks
• Phone: 972528557212
• Email: Shiraw@clalit.org.il
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Completion date: December 2026