Clinical Trials Directory

Trials / Completed

CompletedNCT01235364

Assessment of Pain With Insertion of the Foley Catheter for Induction of Labour

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
42 (actual)
Sponsor
Uppsala University Hospital · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to assess pain in women randomised to digital or speculum placement of a Foley catheter. Pain during cervical ripening with the Foley catheter is also to be evaluated as well as maternal satisfaction with induction of labour.

Detailed description

The most common method described for placing the Foley catheter is under direct visualisation of the cervix during a sterile speculum examination. Another method is to place the catheter during a digital cervical examination. Maternal discomfort/pain during speculum placement of the catheter has been evaluated in a few studies whereas studies that compare the digital method with the speculum method of placement are lacking. The visual analogue scale is used to subjectively assess pain. With a skin conductance algesimeter an objective assessment of pain is possible.

Conditions

Interventions

TypeNameDescription
DEVICEFoley catheterThe Foley catheter was placed with the digital method
DEVICEFoley catheterThe Foley catheter was placed with a speculum

Timeline

Start date
2009-08-01
Primary completion
2010-08-01
Completion
2010-10-01
First posted
2010-11-05
Last updated
2011-08-11

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT01235364. Inclusion in this directory is not an endorsement.