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

This study has been completed.
Sponsor:
Information provided by:
Uppsala University Hospital
ClinicalTrials.gov Identifier:
NCT01235364
First received: November 4, 2010
Last updated: August 10, 2011
Last verified: August 2009

November 4, 2010
August 10, 2011
August 2009
August 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01235364 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Assessment of Pain With Insertion of the Foley Catheter for Induction of Labour
Not Provided

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pain
  • Device: Foley catheter
    The Foley catheter was placed with the digital method
  • Device: Foley catheter
    The Foley catheter was placed with a speculum
  • Experimental: Digital
    The patient was randomized to digital insertion of the Foley catheter
    Intervention: Device: Foley catheter
  • Experimental: Speculum
    Intervention: Device: Foley catheter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
October 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • singleton fetus in cephalic presentation with a Bishop score of 3-5 and
  • indication for induction of labour

Exclusion Criteria:

  • low-lying placenta,
  • undiagnosed vaginal bleeding,
  • more than one previous caesarean section,
  • previous use of an induction or pre-induction agent during the same pregnancy,
  • signs of infection (maternal fever)
  • non- proficiency in the Swedish language.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01235364
D-nr 2009/ 218
No
Dr. Maria Jonsson, Department of obstetrics and gynecology, Uppsala University Hospital. Uppsala
Uppsala University Hospital
Not Provided
Not Provided
Uppsala University Hospital
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP