NCT05606952

Brief Summary

The aim of this study is to calculate the sensitivity and specificity of using color Doppler with pulsed wave Doppler to accurately detect the position of epidural catheter

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2022

Completed
24 days until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2023

Completed
Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

October 31, 2022

Last Update Submit

May 4, 2026

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

  • sensitivity

    Number and percentage of patients in both groups where the flow was detected

    30 min

Study Arms (2)

Group (C)

patients with BMI less than 35

Device: Color Doppler

Group (O)

patients with BMI more than 35

Device: Color Doppler

Interventions

Color DopplerDEVICE

color Doppler with pulsed wave Doppler to accurately detect the position of epidural catheter

Also known as: Epidural catheter
Group (C)Group (O)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsLabour analgesia
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

labouring pregnant women aged 18-45 years with a singleton gestation requesting epidural analgesia.

You may qualify if:

  • obstetric patients admitted for epidural analgesia in the labor department suite (LDS)

You may not qualify if:

  • Patients suffering from coagulopathy.
  • Patients on recent anticoagulant therapy.
  • Patients suffering from sepsis or with local sepsis at the insertion site.
  • Patients with platelet count less than 100,000/dl.
  • Patient refusal.
  • Patient with known allergy to local anesthetic drugs
  • Patients delivered by forceps.
  • Patients who have undergone a cesarean section delivery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menoufia University

Menoufia, Menoufia, 32817, Egypt

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 31, 2022

First Posted

November 7, 2022

Study Start

December 1, 2022

Primary Completion

May 1, 2023

Study Completion

November 10, 2023

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)