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Color Doppler to confirm epidural catheter positioning in parturient, would it help? - Trial PACTR202208533831797

Access comprehensive clinical trial information for PACTR202208533831797 through Pure Global AI's free database. This Early Phase 1 trial is sponsored by Menoufia University and is currently Recruitment Completed. The study focuses on Obstetrics and Gynecology.

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PACTR202208533831797
Early Phase 1
Recruitment Completed
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Trial Details
Pan Africa Clinical Trials Registry โ€ข PACTR202208533831797
Pure Global
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Color Doppler to confirm epidural catheter positioning in parturient, would it help?

Study Focus

Obstetrics and Gynecology

device

Sponsor & Location

Menoufia University

Self funding

Egypt

Timeline & Enrollment

Early Phase 1

Jan 01, 1900

Jan 01, 1900

Summary

Labor pain is ranked as one of the most severe type of pain that women experience during their lifetime. Epidural analgesia is the gold standard technique used to decrease labor pain while providing a favorable maternal and fetal safety profile.1The reported incidence reports of failure of epidural analgesia reached between 13% and 32% depending on the definition of failure adopted done by researchers.2,3 In obstetric population a retrospective study where 75% of patients received epidural analgesia. Results showed an overall failure of 12% while in the same study 6.4% of patients witnessed failure after a preceding time of adequate analgesia.4To decrease the rate of failure, different confirmatory methods have been proposed as epidural stimulation tests5,6, injection of contrast dye7, detecting epidural space waveform pressures8 and ultrasonography.9Specific objectives:The primary outcome is to calculate the sensitivity and specificity of using color Doppler with pulsed wave Doppler to accurately detect the position of epidural catheter in BMI < 35 versus BMI > 35 (morbid obese) parturients in labor.Secondary outcome is to detect the percentage of failure of epidural analgesia defined as inadequate analgesia despite adequate dosing at any time during or after initial epidural placement.

ICD-10 Classifications

Obstetric and gynaecological devices associated with adverse incidents
Obstructed labour due to other maternal pelvic abnormalities
Obstetric and gynaecological devices associated with adverse incidents : miscellaneous devices, not elsewhere classified
Obstetric and gynaecological devices associated with adverse incidents : diagnostic and monitoring devices
Other complications of obstetric surgery and procedures

Data Source

Pan Africa Clinical Trials Registry

PACTR202208533831797

Device Trial