LaborSOFTNCT00959920

Bladder Drainage During Labor: A Randomized Controlled Study of Obstetric Foley Therapy

A study testing Indwelling catheter and Intermittent straight catheterization in people with Labor, run by Loyola University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this study is to compare two clinically-relevant bladder drainage techniques. This is a randomized controlled trial with a single primary outcome of time to delivery. The results will inform clinical decisions about method of catheterization during labor. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Labor
What is being tested?: Indwelling catheter and Intermittent straight catheterization
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 139 participants
Where: 1 siteUnited States
Study dates: Jul 2009to Dec 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Women who present to either Loyola University Medical Center or Loyola at Gottlieb Hospital in active labor or for induction of labor with a singleton pregnancy and who are anticipated to undergo vaginal delivery during the current admission

Who cannot join

Women who are undergoing a scheduled cesarean delivery
Women with a contraindication to either of the 2 study interventions
Multi-fetal gestations
Current or planned tocolysis
Women who are on magnesium prophylaxis

Trial locations and contacts

1 site in 1 country.

United States1 site

Loyola University Health System
Maywood, Illinois, 60153

Other trials in United States

About this study

Official title: Study of Obstetric Foley Therapy (SOFT Trial)

Read the detailed description

Urinary catheterization is a common practice during labor following placement of an epidural for pain control, as this form of anesthesia is known to inhibit normal bladder emptying. There is insufficient evidence to guide clinicians in selection of an indwelling catheter versus intermittent straight catheterization during the course of labor.

The goal of this randomized control trial is to compare two clinically-relevant bladder drainage techniques.

Conditions: Labor
Being tested: Indwelling catheter, Intermittent straight catheterization
Keywords: Indwelling bladder catheter, Intermittent straight catheterization, Labor and Delivery, Time to delivery during labor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Indwelling catheterProcedure or surgery
Indwelling bladder catheter will remain in place until time of delivery.
Intermittent straight catheterizationProcedure or surgery
intermittent straight catheterization will be performed on an as needed basis until time of delivery.

Study groups in NCT00959920
Study group	Role	What they receive
Indwelling foley catheter	Active comparator	Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery. Receives: Procedure: Indwelling catheter
Intermittent straight catheterization	Active comparator	Intermittent straight catheterization will be performed as needed during labor. Receives: Procedure: Intermittent straight catheterization

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Delivery (by Any Route)
Time to delivery defined as IV placement to delivery of infant.
Measured: 1 day

Secondary outcomes (1)

Difference in Cost Between the Two Interventions
Cost of the intermittent vs. foley catheterization procedures was measured and reported in mean dollars.
Measured: End of study.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2009Dec 2009

First posted17 Aug 2009 (estimated)
Study startJul 2009
Primary completionDec 2009
Study completionDec 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for LaborStudies 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: Parallel groups
Masking: None (open label)
Enrolment: 139 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00959920
Sponsor's protocol ID: 201539
Acronym: SOFT
Status last verified: May 2017
First submitted: 14 Aug 2009
Last updated: 19 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Rivard C, Awad M, Liebermann M, Dejong M, Massey SM, Sinacore J, Brubaker L. Bladder drainage during labor: a randomized controlled trial. J Obstet Gynaecol Res. 2012 Aug;38(8):1046-51. doi: 10.1111/j.1447-0756.2011.01837.x. Epub 2012 Apr 30.
PubMed 22540248

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of Obstetric Foley Therapy (SOFT Trial)
ClinicalTrials.gov ID: NCT00959920
Acronym / sponsor ID: SOFT / 201539
Conditions: Labor
Keywords: Indwelling bladder catheter, Intermittent straight catheterization, Labor and Delivery, Time to delivery during labor
Study type: Interventional
Recruitment status: Completed
Enrolment: 139 participants (actual)
Lead sponsor: Loyola UniversityUniversity, hospital or other
Study start: Jul 2009
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 17 Aug 2009 (estimated)
Results: Posted 23 May 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The goal of this randomized control trial is to compare two clinically-relevant bladder drainage techniques.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Indwelling foley catheter	Active comparator	Procedure: Indwelling catheterInsertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.
Intermittent straight catheterization	Active comparator	Procedure: Intermittent straight catheterizationIntermittent straight catheterization will be performed as needed during labor.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Women who present to either Loyola University Medical Center or Loyola at Gottlieb Hospital in active labor or for induction of labor with a singleton pregnancy and who are anticipated to undergo vaginal delivery during the current admission

Key exclusion criteria (5 listed)

Women who are undergoing a scheduled cesarean delivery
Women with a contraindication to either of the 2 study interventions
Multi-fetal gestations
Current or planned tocolysis
Women who are on magnesium prophylaxis

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
Indwelling catheterIndwelling bladder catheter will remain in place until time of delivery.	Procedure or surgery	Indwelling foley catheter
Intermittent straight catheterizationintermittent straight catheterization will be performed on an as needed basis until time of delivery.	Procedure or surgery	Intermittent straight catheterization

Primary outcome

Time to Delivery (by Any Route)
Time frame: 1 day
Time to delivery defined as IV placement to delivery of infant.

1 secondary outcome

Difference in Cost Between the Two Interventions
Time frame: End of study.

Results and safety

Results posted to the registry on 23 May 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Indwelling Foley Catheter	72	72
Intermittent Straight Catheterization	67	66

Primary outcome: Time to Delivery (by Any Route)

Time frame: 1 day. Median (Inter-Quartile Range). Unit: Hours

Measure	Indwelling Foley Catheter n = 72	Intermittent Straight Catheterization n = 66
Value	10.43 (5.52 to 15.34)	11.23 (7.15 to 15.31)

Intermittent Straight Catheterization: Median Difference (Final Values): .8, p = .42, t-test, 2 sided

Population analysed: Our a priori sample size required 138 women (69 per group) for 80% power to detect the clinically relevant 30 minute difference in the time to delivery interval with a .05 alpha error.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Indwelling Foley Catheter	0 of 72 (0%)	0 of 72 (0%)	0 of 72
Intermittent Straight Catheterization	0 of 67 (0%)	0 of 67 (0%)	0 of 67

Limitations and caveats (from the sponsor): The are not limitations or caveats to disclose.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22540248Rivard C, Awad M, Liebermann M, Dejong M, Massey SM, Sinacore J, Brubaker L. Bladder drainage during labor: a randomized controlled trial. J Obstet Gynaecol Res. 2012 Aug;38(8):1046-51. doi: 10.1111/j.1447-0756.2011.01837.x. Epub 2012 Apr 30.
Individual participant dataSharing planned: No

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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.

Sarita Massey, MD principal investigator

Loyola University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Indwelling catheter and Intermittent straight catheterization in people with Labor, run by Loyola University at 1 site in United States.

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 1 inclusion and 5 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 19 May 2017. 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 United States. 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?

Yes. Results are posted in the registry (first posted 23 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Time to Delivery (by Any Route) (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00959920, which also lists 1 linked publication.

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 19 May 2017.