Assessment of Pain With Insertion of the Foley Catheter for Induction of Labour
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|ClinicalTrials.gov Identifier: NCT01235364|
Recruitment Status : Completed
First Posted : November 5, 2010
Last Update Posted : August 11, 2011
|Condition or disease||Intervention/treatment||Phase|
|Pain||Device: Foley catheter||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||October 2010|
The patient was randomized to digital insertion of the Foley catheter
Device: Foley catheter
The Foley catheter was placed with the digital method
Device: Foley catheter
The Foley catheter was placed with a speculum
- Pain assessed by VAS and SCA, in women randomised to digital or speculum placement of a Foley catheter. [ Time Frame: At insertion of Foley catheter ]
- To assess pain with VAS and SCA during cervical ripening with the Foley catheter and to evaluate maternal satisfaction. To evaluate if markers of stress in blood and amniotic fluid correlate with VAS and SCA. [ Time Frame: During treatment with Foley catheter. At expulsion of Foley catehter ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01235364
|Department of obstetrics and gynecology, Uppsala university hospital|
|Uppsala, Sweden, 751 85|