NCT01438099

Brief Summary

This study wants to investigate if ultrasound assisted epidural catheter insertion for labor analgesia is easier and safer to the standard epidural technique.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

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

September 14, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2011

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

August 26, 2013

Status Verified

August 1, 2013

Enrollment Period

1.8 years

First QC Date

September 14, 2011

Last Update Submit

August 23, 2013

Conditions

Pregnancy

Keywords

epidural analgesiaultrasoundlabor analgesialabor

Outcome Measures

Primary Outcomes (1)

  • The congruity between palpatory technique and ultrasound lumbar evaluation

    The congruity between palpatory technique and ultrasound lumbar evaluation to identify the correct spinal space performing epidural analgesia

    participants will be followed for the duration of hospital stay, an expected average of 3 days

Secondary Outcomes (1)

  • Longitudinal and transverse ultrasound epidural space depth in obese and normal parturients

    participants will be followed for the duration of hospital stay, an expected average of 3 days

Study Arms (2)

normal subjects

parturients admitted to the labor ward who request epidural analgesia with BMI \< 30

obese subjects

parturients admitted to the labor ward who request epidural analgesia with BMI \> 30

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

all women after thirty weeks of pregnancy, experiencing spontaneous or induced labor

You may qualify if:

  • all women who request epidural analgesia for labor

You may not qualify if:

  • all women who present contraindication for epidural analgesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda ospedaliera ospedale Circolo e Fondazione Macchi

Varese, Varese, 21100, Italy

Location

Study Officials

  • Paolo Severgnini, Prof.

    Universita' degli Studi dell'Insubria, Varese, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

September 14, 2011

First Posted

September 21, 2011

Study Start

October 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

August 26, 2013

Record last verified: 2013-08

Locations

IT(1)