Viewing Study NCT04210908



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Last Modification Date: 2024-10-26 @ 1:25 PM
Study NCT ID: NCT04210908
Status: COMPLETED
Last Update Posted: 2022-11-30
First Post: 2019-12-15

Brief Title: Biofeedback for Second Stage of Labor
Sponsor: Assuta Ashdod Hospital
Organization: Assuta Ashdod Hospital

Study Overview

Official Title: Ultrasound Imaging Biofeedback for Shortening the Second Stage of Labor a Randomized Prospective Study
Status: COMPLETED
Status Verified Date: 2022-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to examine whether transperineal ultrasound as visual biofeedback can be used during labor as an effective tool for shortening the second stage of labor and reducing the need for instrumental delivery in a prospective randomized design
Detailed Description: Biofeedback provides patients with better control of their body and their physiological reactions respective of the examined process such as stressanxiety sports activity labor etc

Women under epidural anesthesia may frequently feel lack of control over the birthing process and difficulty in bearing down effectively which is a very significant part of the second stage of labor

Transperineal ultrasound during labor is a standard procedure in many medical centers in the world mainly used to assist obstetricians in evaluating the progress of labor fetal head position and assessing the chances of successful operative delivery One of the most common tools used in transperineal ultrasound in measurement of the angle of progression which has been suggested as a subjective method for assessing fetal station and for predicting successful vaginal delivery A preliminary non-randomized study raised the possibility that the use of transperineal ultrasound during labor as a biofeedback tool may shorten the second stage of labor

The purpose of this study is to examine whether this tool can be used during labor as an effective tool for shortening the second stage of labor and reducing the need for instrumental delivery in a prospective randomized design

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None