Pre-induction Cervical RipeningNCT02344459
Comparing 30mL Single Versus 80mL Double Balloon Catheters for Pre-induction Cervical Ripening
A study testing mechanical pre-induction cervical ripening in people with Pre-induction Cervical Ripening, run by University of Washington.
Trial summary
The purpose of this study is to perform a randomized controlled trial to compare the efficacy of 80mL double balloon catheter versus a 30mL single catheter balloon for pre-induction cervical ripening by evaluating the change in Bishop score. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-induction Cervical Ripening
- What is being tested?
- mechanical pre-induction cervical ripening
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Nov 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Bishop score of 5 or less
- Singleton
- Cephalic presentation
- Fewer than 4 contractions in 10 minutes
- Reactive fetal monitoring
Who cannot join
- Non-vertex presentation
- Placenta previa
- Vasa previa
- Unexplained vaginal bleeding
- Active herpes simplex virus infection
- Non-English speaking
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- Previous attempt at an induction of labor in the current pregnancy
- Prolapsed umbilical cord
- More than one prior cesarean delivery or history of classical cesarean delivery
- Patients receiving or planning to undergo exogenous prostaglandin administration as the primary induction agent
About this study
Official title: Randomized Controlled Trial: Comparing 30mL Single Versus 80mL Double Balloon Catheters for Pre-induction Cervical Ripening
The purpose of this study is to perform a randomized controlled trial to compare the efficacy of 80mL double balloon catheter versus a 30mL single catheter balloon for pre-induction cervical ripening by evaluating the change in Bishop score.
- Conditions
- Pre-induction Cervical Ripening
- Being tested
- mechanical pre-induction cervical ripening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical pre-induction cervical ripeningDevice
The balloon catheters have been used to provide mechanical dilation to the cervix as a method of pre-induction cervical ripening.
| Study group | Role | What they receive |
|---|---|---|
| 80mL double balloon catheter (Cook catheter®) | Experimental | Not described Receives: Device: mechanical pre-induction cervical ripening |
| 30mL single Foley balloon catheter | Active comparator | Not described Receives: Device: mechanical pre-induction cervical ripening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bishop score greater than or equal to 6 at time of balloon catheter removal
Measured: until catheter removal (12 hours maximum)
Secondary outcomes (14)
induction to delivery time
Measured: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
vaginal delivery time less than 24 hours from initiation of induction
Measured: 24 hours
mode of delivery
Measured: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
Time to catheter expulsion
Measured: Up to 12 hours
Type of catheter expulsion
spontaneous vs. provider
Measured: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
Epidural utilization
Measured: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
Meconium stained amniotic fluid
Measured: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
5 minute Apgar score
Measured: The participants infant will be monitored from immediately to 5 minutes after birth
Medication required to augment labor
prostaglandins, oxytocin
Measured: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
Artificial rupture of membranes required to augment labor
Measured: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
Cesarean section indications
Measured: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
Neonatal intensive care unit admissions
Measured: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
Chorioamnionitis
Measured: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
birthweight
Measured: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startJan 2010
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-induction Cervical RipeningStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kara Hoppe, University of Washington
- Investigators
- Kara K Hoppe, DO, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344459
- Sponsor's protocol ID
- 36685-D
- Status last verified
- Jan 2015
- First submitted
- 1 Dec 2014
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial: Comparing 30mL Single Versus 80mL Double Balloon Catheters for Pre-induction Cervical Ripening
- ClinicalTrials.gov ID
- NCT02344459
- Acronym / sponsor ID
- 36685-D
- Conditions
- Pre-induction Cervical Ripening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 26 Jan 2015 (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 perform a randomized controlled trial to compare the efficacy of 80mL double balloon catheter versus a 30mL single catheter balloon for pre-induction cervical ripening by evaluating the change in Bishop score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 80mL double balloon catheter (Cook catheter®) | Experimental | Device: mechanical pre-induction cervical ripening |
| 30mL single Foley balloon catheter | Active comparator | Device: mechanical pre-induction cervical ripening |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Bishop score of 5 or less
- Singleton
- Cephalic presentation
- Fewer than 4 contractions in 10 minutes
- Reactive fetal monitoring
Key exclusion criteria (10 listed)
- Non-vertex presentation
- Placenta previa
- Vasa previa
- Unexplained vaginal bleeding
- Active herpes simplex virus infection
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 |
|---|---|---|
| mechanical pre-induction cervical ripeningThe balloon catheters have been used to provide mechanical dilation to the cervix as a method of pre-induction cervical ripening. | Device | 30mL single Foley balloon catheter, 80mL double balloon catheter (Cook catheter®) |
Primary outcome
Bishop score greater than or equal to 6 at time of balloon catheter removal
Time frame: until catheter removal (12 hours maximum)
14 secondary outcomes
induction to delivery time
Time frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
vaginal delivery time less than 24 hours from initiation of induction
Time frame: 24 hours
mode of delivery
Time frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
Time to catheter expulsion
Time frame: Up to 12 hours
Type of catheter expulsion
Time frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
Epidural utilization
Time frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
Meconium stained amniotic fluid
Time frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
5 minute Apgar score
Time frame: The participants infant will be monitored from immediately to 5 minutes after birth
Medication required to augment labor
Time frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
Artificial rupture of membranes required to augment labor
Time frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
Cesarean section indications
Time frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
Neonatal intensive care unit admissions
Time frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
Chorioamnionitis
Time frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
birthweight
Time frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)
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 26 Jan 2015.
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.
Kara K Hoppe, DO principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A study testing mechanical pre-induction cervical ripening in people with Pre-induction Cervical Ripening, run by University of Washington.
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 5 inclusion and 10 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 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Bishop score greater than or equal to 6 at time of balloon catheter removal (time frame: until catheter removal (12 hours maximum)). 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 26 Jan 2015; AzTrials last refreshed its copy on 31 Oct 2026.