Induction of LaborCORCNCT03752073
Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix
A study testing Trans-cervical cervical balloon and Hygroscopic cervical dilator in people with Induction of Labor, run by Ochsner Health System at 2 sites in United States.
Trial summary
This is a randomized prospective trial of two mechanical methods of pre-induction cervical ripening agents. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induction of Labor
- What is being tested?
- Trans-cervical cervical balloon and Hygroscopic cervical dilator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2019to 1 Jan 2023
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women between 39 and 41 weeks gestational age who desire elective induction of labor, based on reliable estimated gestational age (defined as ultrasonography performed before 14 weeks 0 days, or a certain last menstrual period consistent with ultrasonography performed before 21 weeks 0 days).
Who cannot join
- 1. Risk factors for placental insufficiency or intra-partum complication such as intra-uterine growth restriction, hypertensive disease, diabetes requiring insulin therapy, multiple gestation, history of previous hysterotomy, cholestasis of pregnancy, placental abnormalities including low lying placenta (< 2 cm from cervical os), maternal cardiac disease, maternal pulmonary disease, known fetal anomaly, fetal demise, etc.
- 2. Simplified Bishop score must be <6 and cervical dilation <2 cm.
- 3. Women must be able to give informed consent.
- 4. Concern regarding fetal well-being, conditions which preclude vaginal birth, group B strep carriers, patients who are HIV, Hep B or Hep C positive.
- 5. Women allergic to povidone-iodine, aquacryl hydrogel or the latex-free Foley catheter.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigid McCue
Bay Shore, New York, 11706
Ochsner Baptist Hospital
New Orleans, Louisiana, 70115
About this study
This is a randomized prospective trial of two mechanical methods of pre-induction cervical ripening agents.
Read the detailed description
Term, low risk patients requesting elective induction of labor who desire pre-induction cervical ripening at home will be randomized to receive an outpatient trans-cervical ripening balloon (17 F non-latex Foley catheter) or hygroscopic cervical dilator (Dilapan-S). Patients present to the hospital for their scheduled induction of labor approximately 12 hours later.
We hypothesize that the trans-cervical balloon and hygroscopic dilators will show equivalent efficacy in cervical ripening, but that pain scores and patient satisfaction will be better with the hygroscopic dilators.
- Conditions
- Induction of Labor
- Being tested
- Trans-cervical cervical balloon, Hygroscopic cervical dilator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-cervical cervical balloonDevice
Insertion of Foley Catheter
Hygroscopic cervical dilatorDevice
Insertion of Dilapan-s
| Study group | Role | What they receive |
|---|---|---|
| Trans-cervical cervical balloon | Experimental | 17 F non-latex Foley catheter will be placed and balloon filled with 30 cc of sterile normal saline. Receives: Device: Trans-cervical cervical balloon |
| Hygroscopic cervical dilators | Experimental | Dilapan-S hygroscopic dilators will be placed into the cervix at the level of the internal os. Receives: Device: Hygroscopic cervical dilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from start of cervical ripening to delivery
Time in minutes from placement of cervical ripening agent to delivery
Measured: 720-2160 minutes
Secondary outcomes (3)
Pain of insertion
Patient assessment of pain on insertion using pain analog scale
Measured: First hour
Pain over duration of cervical ripening
Patient assessment of pain on admission using pain analog scale
Measured: 12-14 hours
Patient satisfaction with cervical ripening agent
Patient survey postpartum day #1 regarding cervical ripening experience
Measured: 24-36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start1 Mar 2019
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Why it stopped: Difficulty enrolling patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Induction of 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
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ochsner Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Northwell Health
- Responsible party
- Sponsor
- Investigators
- Brigid McCue, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752073
- Sponsor's protocol ID
- STUDY00000397
- Acronym
- CORC
- Status last verified
- Apr 2023
- First submitted
- 4 Oct 2018
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. doi: 10.1016/s0029-7844(01)01579-4.
PubMed 11704164Sciscione AC, Bedder CL, Hoffman MK, Ruhstaller K, Shlossman PA. The timing of adverse events with Foley catheter preinduction cervical ripening; implications for outpatient use. Am J Perinatol. 2014 Oct;31(9):781-6. doi: 10.1055/s-0033-1359718. Epub 2013 Dec 17.
PubMed 24347259Gilson GJ, Russell DJ, Izquierdo LA, Qualls CR, Curet LB. A prospective randomized evaluation of a hygroscopic cervical dilator, Dilapan, in the preinduction ripening of patients undergoing induction of labor. Am J Obstet Gynecol. 1996 Jul;175(1):145-9. doi: 10.1016/s0002-9378(96)70264-8.
PubMed 8694040Shindo R, Aoki S, Yonemoto N, Yamamoto Y, Kasai J, Kasai M, Miyagi E. Hygroscopic dilators vs balloon catheter ripening of the cervix for induction of labor in nulliparous women at term: Retrospective study. PLoS One. 2017 Dec 22;12(12):e0189665. doi: 10.1371/journal.pone.0189665. eCollection 2017.
PubMed 29272277Kuper SG, Jauk VC, George DM, Edwards RK, Szychowski JM, Mazzoni SE, Wang MJ, Files P, Tita AT, Subramaniam A, Harper LM. Outpatient Foley Catheter for Induction of Labor in Parous Women: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jul;132(1):94-101. doi: 10.1097/AOG.0000000000002678.
PubMed 29889751Lu AMR, Lin B, Shahani D, Demertzis K, Muscat J, Zabel E, Olson P, Manayan O, Nonnamaker E, Fest J, McCue B. Randomized control trial comparing hygroscopic cervical dilators to cervical ripening balloon for outpatient cervical ripening. Am J Obstet Gynecol MFM. 2024 Apr;6(4):101318. doi: 10.1016/j.ajogmf.2024.101318. Epub 2024 Feb 28.
PubMed 38417552de 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 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix
- ClinicalTrials.gov ID
- NCT03752073
- Acronym / sponsor ID
- CORC / STUDY00000397
- Conditions
- Induction of Labor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty enrolling patients
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Ochsner Health SystemUniversity, hospital or other
- Collaborators
- Northwell Health
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 23 Nov 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.
This is a randomized prospective trial of two mechanical methods of pre-induction cervical ripening agents.
Detailed description
Term, low risk patients requesting elective induction of labor who desire pre-induction cervical ripening at home will be randomized to receive an outpatient trans-cervical ripening balloon (17 F non-latex Foley catheter) or hygroscopic cervical dilator (Dilapan-S). Patients present to the hospital for their scheduled induction of labor approximately 12 hours later.
We hypothesize that the trans-cervical balloon and hygroscopic dilators will show equivalent efficacy in cervical ripening, but that pain scores and patient satisfaction will be better with the hygroscopic dilators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trans-cervical cervical balloon | Experimental | Device: Trans-cervical cervical balloon17 F non-latex Foley catheter will be placed and balloon filled with 30 cc of sterile normal saline. |
| Hygroscopic cervical dilators | Experimental | Device: Hygroscopic cervical dilatorDilapan-S hygroscopic dilators will be placed into the cervix at the level of the internal os. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women between 39 and 41 weeks gestational age who desire elective induction of labor, based on reliable estimated gestational age (defined as ultrasonography performed before 14 weeks 0 days, or a certain last menstrual period consistent with ultrasonography performed before 21 weeks 0 days).
Key exclusion criteria (5 listed)
- 1. Risk factors for placental insufficiency or intra-partum complication such as intra-uterine growth restriction, hypertensive disease, diabetes requiring insulin therapy, multiple gestation, history of previous hysterotomy, cholestasis of pregnancy, placental abnormalities including low lying placenta (< 2 cm from cervical os), maternal cardiac disease, maternal pulmonary disease, known fetal anomaly, fetal demise, etc.
- 2. Simplified Bishop score must be <6 and cervical dilation <2 cm.
- 3. Women must be able to give informed consent.
- 4. Concern regarding fetal well-being, conditions which preclude vaginal birth, group B strep carriers, patients who are HIV, Hep B or Hep C positive.
- 5. Women allergic to povidone-iodine, aquacryl hydrogel or the latex-free Foley catheter.
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 |
|---|---|---|
| Trans-cervical cervical balloonInsertion of Foley Catheter | Device | Trans-cervical cervical balloon |
| Hygroscopic cervical dilatorInsertion of Dilapan-s | Device | Hygroscopic cervical dilators |
Primary outcome
Time from start of cervical ripening to delivery
Time frame: 720-2160 minutes
Time in minutes from placement of cervical ripening agent to delivery
3 secondary outcomes
Pain of insertion
Time frame: First hour
Pain over duration of cervical ripening
Time frame: 12-14 hours
Patient satisfaction with cervical ripening agent
Time frame: 24-36 hours
Results and safety
The study was stopped early (reason given: Difficulty enrolling patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Background: PubMed 11704164Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. doi: 10.1016/s0029-7844(01)01579-4.
- Background: PubMed 24347259Sciscione AC, Bedder CL, Hoffman MK, Ruhstaller K, Shlossman PA. The timing of adverse events with Foley catheter preinduction cervical ripening; implications for outpatient use. Am J Perinatol. 2014 Oct;31(9):781-6. doi: 10.1055/s-0033-1359718. Epub 2013 Dec 17.
- Background: PubMed 8694040Gilson GJ, Russell DJ, Izquierdo LA, Qualls CR, Curet LB. A prospective randomized evaluation of a hygroscopic cervical dilator, Dilapan, in the preinduction ripening of patients undergoing induction of labor. Am J Obstet Gynecol. 1996 Jul;175(1):145-9. doi: 10.1016/s0002-9378(96)70264-8.
- Background: PubMed 29272277Shindo R, Aoki S, Yonemoto N, Yamamoto Y, Kasai J, Kasai M, Miyagi E. Hygroscopic dilators vs balloon catheter ripening of the cervix for induction of labor in nulliparous women at term: Retrospective study. PLoS One. 2017 Dec 22;12(12):e0189665. doi: 10.1371/journal.pone.0189665. eCollection 2017.
- Results publication: PubMed 29889751Kuper SG, Jauk VC, George DM, Edwards RK, Szychowski JM, Mazzoni SE, Wang MJ, Files P, Tita AT, Subramaniam A, Harper LM. Outpatient Foley Catheter for Induction of Labor in Parous Women: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jul;132(1):94-101. doi: 10.1097/AOG.0000000000002678.
- Derived from this study: PubMed 38417552Lu AMR, Lin B, Shahani D, Demertzis K, Muscat J, Zabel E, Olson P, Manayan O, Nonnamaker E, Fest J, McCue B. Randomized control trial comparing hygroscopic cervical dilators to cervical ripening balloon for outpatient cervical ripening. Am J Obstet Gynecol MFM. 2024 Apr;6(4):101318. doi: 10.1016/j.ajogmf.2024.101318. Epub 2024 Feb 28.
- 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: 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.
Brigid McCue, MD principal investigator
Northwell Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-cervical cervical balloon and Hygroscopic cervical dilator in people with Induction of Labor, run by Ochsner Health System at 2 sites 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: stopped early, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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: Difficulty enrolling patients). 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 from start of cervical ripening to delivery (time frame: 720-2160 minutes). 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 NCT03752073, which also lists 7 linked publications.
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 25 Apr 2023.