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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Device: Foley catheter

• Registration Number: NCT01235364
• Lead Sponsor: Uppsala University Hospital

Brief 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.

Study Timeline

• Status Verified: 2009-08
• Study Start: 2009-08
• Primary Completion: 2010-08
• Study Completion: 2010-10
• Study First Submitted: 2010-11-04
• Study First Submitted QC: 2010-11-04
• Study First Posted: 2010-11-05
• Last Update Submitted: 2011-08-10
• Last Update Posted: 2011-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Digital	Foley catheter	The patient was randomized to digital insertion of the Foley catheter
Speculum	Foley catheter	-

Primary Outcome Measures

Name	Time	Method
Pain assessed by VAS and SCA, in women randomised to digital or speculum placement of a Foley catheter.	At insertion of Foley catheter

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of obstetrics and gynecology, Uppsala university hospital; 🇸🇪 Uppsala, Sweden