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
  Purpose

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.


Condition Intervention
Pain
Device: Foley catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Uppsala University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 42
Study Start Date: August 2009
Study Completion Date: October 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Digital
The patient was randomized to digital insertion of the Foley catheter
Device: Foley catheter
The Foley catheter was placed with the digital method
Experimental: Speculum Device: Foley catheter
The Foley catheter was placed with a speculum

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01235364

Locations
Sweden
Department of obstetrics and gynecology, Uppsala university hospital
Uppsala, Sweden, 751 85
Sponsors and Collaborators
Uppsala University Hospital
  More Information

No publications provided

Responsible Party: Dr. Maria Jonsson, Department of obstetrics and gynecology, Uppsala University Hospital. Uppsala
ClinicalTrials.gov Identifier: NCT01235364     History of Changes
Other Study ID Numbers: D-nr 2009/ 218
Study First Received: November 4, 2010
Last Updated: August 10, 2011
Health Authority: Sweden:Regional Ethical Review Board, Uppsala

Keywords provided by Uppsala University Hospital:
Foley catheter
induction
labour
skin conductance
visual analogue scale
mechanical method

ClinicalTrials.gov processed this record on September 11, 2014