PainNCT01235364
Assessment of Pain With Insertion of the Foley Catheter for Induction of Labour
A study testing Foley catheter in people with Pain, run by Uppsala University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain
- What is being tested?
- Foley catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2009to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- singleton fetus in cephalic presentation with a Bishop score of 3-5 and
- indication for induction of labour
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Sweden1 site
Department of obstetrics and gynecology, Uppsala university hospital
Uppsala, 751 85
About this study
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.
Read the 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.
- Conditions
- Pain
- Being tested
- Foley catheter
- Keywords
- Foley catheter, induction, labour, skin conductance, visual analogue scale, mechanical method
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foley catheterDevice
The Foley catheter was placed with the digital method
Foley catheterDevice
The Foley catheter was placed with a speculum
| Study group | Role | What they receive |
|---|---|---|
| Digital | Experimental | The patient was randomized to digital insertion of the Foley catheter Receives: Device: Foley catheter |
| Speculum | Experimental | Not described Receives: Device: Foley catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessed by VAS and SCA, in women randomised to digital or speculum placement of a Foley catheter.
Measured: At insertion of Foley catheter
Secondary outcomes (1)
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.
Measured: During treatment with Foley catheter. At expulsion of Foley catehter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2010 (estimated)
- Study startAug 2009
- Primary completionAug 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235364
- Sponsor's protocol ID
- D-nr 2009/ 218
- Status last verified
- Aug 2009
- First submitted
- 4 Nov 2010
- Last updated
- 11 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pain With Insertion of the Foley Catheter for Induction of Labour
- ClinicalTrials.gov ID
- NCT01235364
- Acronym / sponsor ID
- D-nr 2009/ 218
- Conditions
- Pain
- Keywords
- Foley catheter, induction, labour, skin conductance, visual analogue scale, mechanical method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 5 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital | Experimental | Device: Foley catheterThe patient was randomized to digital insertion of the Foley catheter |
| Speculum | Experimental | Device: Foley catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- singleton fetus in cephalic presentation with a Bishop score of 3-5 and
- indication for induction of labour
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foley catheterThe Foley catheter was placed with the digital method | Device | Digital |
| Foley catheterThe Foley catheter was placed with a speculum | Device | Speculum |
Primary outcome
Pain assessed by VAS and SCA, in women randomised to digital or speculum placement of a Foley catheter.
Time frame: At insertion of Foley catheter
1 secondary outcome
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.
Time frame: During treatment with Foley catheter. At expulsion of Foley catehter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foley catheter in people with Pain, run by Uppsala University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessed by VAS and SCA, in women randomised to digital or speculum placement of a Foley catheter. (time frame: At insertion of Foley catheter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2011.