Cervical RipeningPhase 4NCT01170819
Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening.
A Phase 4 study testing Double balloon catheter in people with Cervical Ripening and Labor Induction, run by Università degli Studi dell'Insubria at 1 site in Italy.
Trial summary
To compare the efficacy of transcervical double balloon catheters versus controlled release dinoprostone vaginal inserts for pre-induction cervical ripening in term women with unfavourable cervices. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Ripening, Labor Induction
- What is being tested?
- Double balloon catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2010to Dec 2011
- Phase
- Phase 4
- 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
- singleton gestation
- gestational age greater than 34 weeks
- cephalic presentation
- intact membranes
- Bishop score of ≤4
- reactive fetal heart rate (FHR) pattern on admission
Who cannot join
- any condition precluding vaginal delivery
- any contraindication to receiving prostaglandins, including history of asthma, glaucoma, or cardiac or cardiovascular disease
- previous cesarean section or other uterine incision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Balloon Catheter Versus Vaginal PGE2 for Pre-induction Cervical Ripening: a Randomized Study.
To compare the efficacy of transcervical double balloon catheters versus controlled release dinoprostone vaginal inserts for pre-induction cervical ripening in term women with unfavourable cervices.
- Conditions
- Cervical Ripening, Labor Induction
- Being tested
- Double balloon catheter, Dinoprostone 10 mg controlled-release vaginal insert
- Keywords
- Cervical ripening, Induction of labor, Prostaglandins, Mechanical methods, Balloon catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double balloon catheterDevice
Also called COOK CERVICAL BALLOON, COOK UROLOGICAL INC. US
The balloons either side of the cervix are inflated with 50 ml of water. The catheter is removed after 12 hours if spontaneous expulsion has not occurred.
Dinoprostone 10 mg controlled-release vaginal insertDrug
Also called PROPESS®, Ferring Pharmaceuticals
Vaginal insert is placed in the posterior vaginal fornix for a maximum period of 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Dinoprostone Vaginal Insert | Active comparator | Not described Receives: Drug: Dinoprostone 10 mg controlled-release vaginal insert |
| Double Balloon Catheter | Experimental | Not described Receives: Device: Double balloon catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal delivery within 24 hours
Measured: 24 hours from start of cervical ripening
Secondary outcomes (3)
Cesarean section rate
Measured: 48 hours from start of ripening
Onset of active labor
Active labor is defined as at least 4 uterine contractions in a 30 minutes interval with a totally effaced cervix and a cervical dilatation ≥3 cm
Measured: 36 hours from start of ripening
Uterine hyperstimulation
Measured: 12 hours (double ballon catheter arm) and 24 hours (dinoprostone vaginal insert arm) from start of ripening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2011
- Study completionDec 2011
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 Cervical RipeningStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonella Cromi, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170819
- Sponsor's protocol ID
- 1229
- Status last verified
- Dec 2011
- First submitted
- 23 Jul 2010
- Last updated
- 13 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
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 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Balloon Catheter Versus Vaginal PGE2 for Pre-induction Cervical Ripening: a Randomized Study.
- ClinicalTrials.gov ID
- NCT01170819
- Acronym / sponsor ID
- 1229
- Conditions
- Cervical Ripening, Labor Induction
- Keywords
- Cervical ripening, Induction of labor, Prostaglandins, Mechanical methods, Balloon catheter
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 27 Jul 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.
To compare the efficacy of transcervical double balloon catheters versus controlled release dinoprostone vaginal inserts for pre-induction cervical ripening in term women with unfavourable cervices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dinoprostone Vaginal Insert | Active comparator | Drug: Dinoprostone 10 mg controlled-release vaginal insert |
| Double Balloon Catheter | Experimental | Device: Double balloon catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- singleton gestation
- gestational age greater than 34 weeks
- cephalic presentation
- intact membranes
- Bishop score of ≤4
Key exclusion criteria (3 listed)
- any condition precluding vaginal delivery
- any contraindication to receiving prostaglandins, including history of asthma, glaucoma, or cardiac or cardiovascular disease
- previous cesarean section or other uterine incision
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 |
|---|---|---|
| Double balloon catheterAlso: COOK CERVICAL BALLOON, COOK UROLOGICAL INC. USThe balloons either side of the cervix are inflated with 50 ml of water. The catheter is removed after 12 hours if spontaneous expulsion has not occurred. | Device | Double Balloon Catheter |
| Dinoprostone 10 mg controlled-release vaginal insertAlso: PROPESS®, Ferring PharmaceuticalsVaginal insert is placed in the posterior vaginal fornix for a maximum period of 24 hours. | Drug | Dinoprostone Vaginal Insert |
Primary outcome
Vaginal delivery within 24 hours
Time frame: 24 hours from start of cervical ripening
3 secondary outcomes
Cesarean section rate
Time frame: 48 hours from start of ripening
Onset of active labor
Time frame: 36 hours from start of ripening
Uterine hyperstimulation
Time frame: 12 hours (double ballon catheter arm) and 24 hours (dinoprostone vaginal insert arm) from start of 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 13 Dec 2011.
- 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.
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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 Phase 4 study testing Double balloon catheter in people with Cervical Ripening and Labor Induction, run by Università degli Studi dell'Insubria at 1 site in Italy.
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 6 inclusion and 3 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 13 Dec 2011. 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 Italy. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Vaginal delivery within 24 hours (time frame: 24 hours from start of cervical ripening). 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 NCT01170819, 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 13 Dec 2011.