Induction of Labor Affected Fetus / NewbornNCT03588585
Tension Versus no Tension With Foley Bulb Induction
A study testing Tension and NO TENSION in people with Induction of Labor Affected Fetus / Newborn, run by Hawaii Pacific Health at 1 site in United States.
Trial summary
To compare the application of tension versus no tension in Foley transcervical catheters for pre-induction cervical ripening. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Induction of Labor Affected Fetus / Newborn
- What is being tested?
- Tension and NO TENSION
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2018to 9 Feb 2026
- 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
- Nulliparas with singleton live intrauterine pregnancies undergoing labor induction at Kapiolani Medical Center for Women and Children.
- Cephalic presentation
- Intact fetal membranes
- Bishop score less than or equal to 6
- Age greater than or equal to 18 years
Who cannot join
- Multiparas
- Multiple gestation
- Previous uterine/cervical surgery
- Ruptured fetal membranes
- Fetal malpresentation
- Any contraindication to vaginal delivery at time of admission
Trial locations and contacts
1 site in 1 country.
United States1 site
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
About this study
Official title: A Prospective, Randomized Comparison of Tension Versus no Tension With Foley Transcervical Catheters for Pre-induction Cervical Ripening
To compare the application of tension versus no tension in Foley transcervical catheters for pre-induction cervical ripening.
Read the detailed description
Patients who are scheduled to undergo labor induction will be offered inclusion in the study which will attempt to determine if placing tension on the foley ballon will shorten the interval between induction initiation and delivery.
- Being tested
- Tension, NO TENSION
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TensionProcedure or surgery
Also called misoprostil 25 mcg
Tension applied to catheter and taped firmly to leg.
NO TENSIONProcedure or surgery
Also called misoprostil 25 mcg
Foley balloon will be taped loosely to the leg and not placed on tension. All other care will remain the same
| Study group | Role | What they receive |
|---|---|---|
| Tension | Active comparator | foley balloon will be placed on tension and taped to thigh at 10 cm. Misoprostil will be placed in posterior vaginal vault. Receives: Procedure: Tension |
| No tension | Active comparator | The foley balloon will be loosely taped without tension to the patient's thigh. Misoprostil will be placed in the posterior vaginal vault. Receives: Procedure: NO TENSION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Delivery
Reduction in time to delivery
Measured: Will measure length of time from beginning of induction with the foley balloon until delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start16 Apr 2018
- Primary completion9 Feb 2026
- Study completion9 Feb 2026
Why it stopped: Study terminated due to low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Induction of Labor Affected Fetus / NewbornStudies 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
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawaii Pacific Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Holly Olson, Hawaii Pacific Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588585
- Sponsor's protocol ID
- 2017-077
- Status last verified
- Feb 2026
- First submitted
- 22 Jun 2018
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
PubMed 36996264
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Comparison of Tension Versus no Tension With Foley Transcervical Catheters for Pre-induction Cervical Ripening
- ClinicalTrials.gov ID
- NCT03588585
- Acronym / sponsor ID
- 2017-077
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to low enrollment.
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Hawaii Pacific HealthUniversity, hospital or other
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 9 Feb 2026 (actual)
- Study completion
- 9 Feb 2026 (actual)
- First posted
- 17 Jul 2018 (actual)
- 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.
To compare the application of tension versus no tension in Foley transcervical catheters for pre-induction cervical ripening.
Detailed description
Patients who are scheduled to undergo labor induction will be offered inclusion in the study which will attempt to determine if placing tension on the foley ballon will shorten the interval between induction initiation and delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tension | Active comparator | Procedure: Tensionfoley balloon will be placed on tension and taped to thigh at 10 cm. Misoprostil will be placed in posterior vaginal vault. |
| No tension | Active comparator | Procedure: NO TENSIONThe foley balloon will be loosely taped without tension to the patient's thigh. Misoprostil will be placed in the posterior vaginal vault. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Nulliparas with singleton live intrauterine pregnancies undergoing labor induction at Kapiolani Medical Center for Women and Children.
- Cephalic presentation
- Intact fetal membranes
- Bishop score less than or equal to 6
- Age greater than or equal to 18 years
Key exclusion criteria (6 listed)
- Multiparas
- Multiple gestation
- Previous uterine/cervical surgery
- Ruptured fetal membranes
- Fetal malpresentation
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 |
|---|---|---|
| TensionAlso: misoprostil 25 mcgTension applied to catheter and taped firmly to leg. | Procedure or surgery | Tension |
| NO TENSIONAlso: misoprostil 25 mcgFoley balloon will be taped loosely to the leg and not placed on tension. All other care will remain the same | Procedure or surgery | No tension |
Primary outcome
Time to Delivery
Time frame: Will measure length of time from beginning of induction with the foley balloon until delivery
Reduction in time to delivery
Results and safety
The study was stopped early (reason given: Study terminated due to low enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Derived from this study: PubMed 36996264de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
- Individual participant dataSharing planned: Undecided
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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 Tension and NO TENSION in people with Induction of Labor Affected Fetus / Newborn, run by Hawaii Pacific Health 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 5 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: stopped early, as of the sponsor's last update on 19 Feb 2026. 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?
The study was stopped early (reason given: Study terminated due to low enrollment.). Results are not available in the source record.
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 (time frame: Will measure length of time from beginning of induction with the foley balloon until delivery). 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 NCT03588585, 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 Feb 2026.