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

Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01235364
• Other study ID #: D-nr 2009/ 218
• Status: Completed
• Phase: N/A
• First received: November 4, 2010
• Last updated: August 10, 2011
• Start date: August 2009
• Est. completion date: October 2010

Study information

• Verified date: August 2009
• Source: Uppsala University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden:Regional Ethical Review Board, Uppsala
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• Foley catheter
The Foley catheter was placed with the digital method
• Foley catheter
The Foley catheter was placed with a speculum

Locations

Country	Name	City	State
Sweden	Department of obstetrics and gynecology, Uppsala university hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessed by VAS and SCA, in women randomised to digital or speculum placement of a Foley catheter.		At insertion of Foley catheter	No
Secondary	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.		During treatment with Foley catheter. At expulsion of Foley catehter	No