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

Uppsala University Hospital

Status: Completed

Conditions: Pain

Treatments: Device: Foley catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT01235364

D-nr 2009/ 218

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Digital

Experimental group

Description:

The patient was randomized to digital insertion of the Foley catheter

Treatment:

Device: Foley catheter

Device: Foley catheter

Speculum

Experimental group

Treatment:

Device: Foley catheter

Device: Foley catheter