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

NCT ID: NCT01235364

Last Updated: 2011-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-10-31

Brief Summary

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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

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Digital

The patient was randomized to digital insertion of the Foley catheter

Group Type EXPERIMENTAL

Foley catheter

Intervention Type DEVICE

The Foley catheter was placed with the digital method

Speculum

Group Type EXPERIMENTAL

Foley catheter

Intervention Type DEVICE

The Foley catheter was placed with a speculum

Interventions

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Foley catheter

The Foley catheter was placed with the digital method

Intervention Type DEVICE

Foley catheter

The Foley catheter was placed with a speculum

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Department of obstetrics and gynecology, Uppsala University Hospital. Uppsala

Locations

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Department of obstetrics and gynecology, Uppsala university hospital

Uppsala, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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D-nr 2009/ 218

Identifier Type: -

Identifier Source: org_study_id

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