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

Study Overview
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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

Intervention / Treatment
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* Device: Foley catheter
* Device: Foley catheter


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital<br>The patient was randomized to digital insertion of the Foley catheter | Device: Foley catheter<br>* The Foley catheter was placed with the digital method<br>|
| Experimental: Speculum<br> | Device: Foley catheter<br>* The Foley catheter was placed with a speculum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Foley catheter, induction, labour, skin conductance, visual analogue scale, mechanical method