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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01235364

Enrollment

Registered

2010-11-05

Start date

2009-08-31

Completion date

2010-10-31

Last updated

2011-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Foley catheter, induction, labour, skin conductance, visual analogue scale, mechanical method

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.

Interventions

DEVICEFoley catheter

The Foley catheter was placed with the digital method

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026