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Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations — SOFIE  

Labor Complication Clinical Trial

Official title:
Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations

Clinical Trial Summary

This is a prospective, randomized trial to determine whether the use of sonographic parameters during labor results in less intrapartum infection compared to traditional invasive examination. Other secondary outcomes include maternal satisfaction and overall birth outcomes.

Clinical Trial Description

It is a prospective, randomized trial to determine whether the use of sonographic parameters during childbirth results in less intrapartum infection compared to traditional invasive examination. Intrapartum non-invasive ultrasound has been established and validated as a method of assessing labor progress. Guidelines from international societies recommend the use of ultrasound to monitor labor and support decision-making during delivery. Despite its reproducibility and reliability, there is no comprehensive work to date demonstrating the potential benefit in reducing clinical chorioamnionitis compared to traditional invasive vaginal examination. With this in mind, the investigators set out to analyze the clinical benefit of using ultrasound alone using established non-invasive, intrapartum, translabial parameters (Angle of Progression, Head Perineum Distance, Midline Angle, Cervix Dilatation) to monitor birth outcomes compared to traditional invasive vaginal examinations. Primary Outcome is the incidence of clinical chorioamnionitis. Secondary Outcome measures include mode of delivery and neonatal outcomes such as neonatal admission. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06261710
Study type Interventional
Source Charite University, Berlin, Germany
Contact Larry Hinkson, FRCOG
Phone 030450664710
Email Larry.Hinkson@charite.de
Status Recruiting
Phase N/A
Start date February 27, 2024
Completion date February 1, 2030
View Details
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