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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital | Experimental | The patient was randomized to digital insertion of the Foley catheter |
|
| Speculum | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foley catheter | Device | The Foley catheter was placed with the digital method |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of obstetrics and gynecology, Uppsala university hospital | Uppsala | 751 85 | Sweden |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Foley catheter |
| Device |
The Foley catheter was placed with a speculum |
|