PregnancyPhase 3NCT01063244
Comparison of Foley Balloon With or Without Traction for the Cervical Ripening
A Phase 3 study testing foley balloon only and foley balloon with weight attached in people with Pregnancy, run by St. Luke's Hospital, Pennsylvania at 1 site in United States.
Trial summary
We will compare the use of foley bulb catheters placed in the cervix for ripening of the cervix for labor induction,. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- foley balloon only and foley balloon with weight attached
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jan 2012
- Phase
- Phase 3
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Term pregnancy scheduled for induction of labor
Who cannot join
- Preterm pregnancy that require induction for fetal indications
Trial locations and contacts
1 site in 1 country.
United States1 site
St Luke's Hosptial & Health Network
Bethlehem, Pennsylvania, 18015
About this study
We will compare the use of foley bulb catheters placed in the cervix for ripening of the cervix for labor induction,.
Read the detailed description
One arm will have the foley balloon placed alone in the cervix. And one arm will have the foley balloon placed in the cervix and then attached to a weight (1000 cc Iv Bag of fluid). Our hypothesis is that the weighted balloon will be more effective than the non-weighted balloon in the ripening of the cervix for induction of labor
- Conditions
- Pregnancy
- Being tested
- foley balloon only, foley balloon with weight attached
- Keywords
- pregnancy, induction of Labor, Cervical ripening, Foley balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foley balloon onlyDevice
place foley balloon only in cervix
foley balloon with weight attachedDevice
foley balloon with 1000cc IV bag attached
| Study group | Role | What they receive |
|---|---|---|
| FoleyBalloon | Active comparator | foley balloon placed in the cervix Receives: Device: foley balloon only |
| foley balloon with weight | Active comparator | foley balloon with weight attached Receives: Device: foley balloon with weight attached |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to effectively ripen cervix
Measured: to effective cervical ripening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startJan 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's Hospital, Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Anasti, MD, St. Luke's Hospital, Pennsylvania
- Investigators
- James N Aansti, MD, Principal investigator, St. Luke's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063244
- Sponsor's protocol ID
- SLHN-08-21
- Status last verified
- Apr 2016
- First submitted
- 3 Feb 2010
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Foley Balloon With or Without Traction for the Cervical Ripening
- ClinicalTrials.gov ID
- NCT01063244
- Acronym / sponsor ID
- SLHN-08-21
- Conditions
- Pregnancy
- Keywords
- pregnancy, induction of Labor, Cervical ripening, Foley balloon
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- St. Luke's Hospital, PennsylvaniaUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 5 Feb 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.
We will compare the use of foley bulb catheters placed in the cervix for ripening of the cervix for labor induction,.
Detailed description
One arm will have the foley balloon placed alone in the cervix. And one arm will have the foley balloon placed in the cervix and then attached to a weight (1000 cc Iv Bag of fluid). Our hypothesis is that the weighted balloon will be more effective than the non-weighted balloon in the ripening of the cervix for induction of labor
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FoleyBalloon | Active comparator | Device: foley balloon onlyfoley balloon placed in the cervix |
| foley balloon with weight | Active comparator | Device: foley balloon with weight attachedfoley balloon with weight attached |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Term pregnancy scheduled for induction of labor
Key exclusion criteria (1 listed)
- Preterm pregnancy that require induction for fetal indications
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 balloon onlyplace foley balloon only in cervix | Device | FoleyBalloon |
| foley balloon with weight attachedfoley balloon with 1000cc IV bag attached | Device | foley balloon with weight |
Primary outcome
Time to effectively ripen cervix
Time frame: to effective cervical ripening
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 18 Apr 2016.
- 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.
James N Aansti, MD principal investigator
St. Luke's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing foley balloon only and foley balloon with weight attached in people with Pregnancy, run by St. Luke's Hospital, Pennsylvania 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 1 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 18 Apr 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to effectively ripen cervix (time frame: to effective cervical ripening). 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 18 Apr 2016.