DeliveryBALLODINONCT02649920
Comparing the Efficiency of Cervical Ripening BALLoon (Cook) to the DINOprostone (Propess) for the Cervical Maturation in Case of Unfavorable Cervix (Bishop <6) in the Population of Obese Pregnant Women (BMI >= 30 kg/m²)
A study testing Cervical ripening balloon and Dinoprostone in people with Delivery, run by Centre Hospitalier Departemental Vendee at 2 sites in France.
Trial summary
At the moment in France, one delivery on four is induced for a medical indication. In this context, the practitioners are exposed to an additional difficulty when the clinical examination of the patient reveals a unfavorable cervix because the main drug used for the releases cannot be used and the cervix must be… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Delivery
- What is being tested?
- Cervical ripening balloon and Dinoprostone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2016to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age ≥ 18 years
- Term ≥ 37 weeks of amenorrhea
- Singleton pregnancy
- Cephalic presentation
- Medical indication of release and unfavorable cervix (Bishop <6)
- BM pre-pregnancy ≥ 30 kg/m2
- Having given their agreement for the participation of the study
- Patient receiving social coverage
Who cannot join
- Age < 18 years
- Term < 37 weeks of amenorrhea
- Multiple pregnancy
- Favorable cervix (Bishop ≥ 6)
- Contraindication of vaginal delivery: praevia placenta, transverse presentation, cord prolapse
- Evolutive urinary tract infection (positive urine dip: leukocytes/ nitrites)
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- Not affiliated with a legal protection regime
- Patient trust, guardianship, under legal protection measure, deprived of freedom
- Balloon's contraindications:
- Abnormal pelvis structure
- Evolutive genital herpes
- Invasive cervical cancer
- Anomaly of foetal heart rate
- Breech presentation
- Maternal heart disorder
- Hydramnios
- Serious and uncontrolled arterial high blood pressure
- Rupture of membranes
- Medical histories of hysterotomy, classic uterine section, myomectomy or quite different uterine section of full thickness
- Presentation above superior pelvic strait
- Dinoprostone's contraindications:
- Scarred uterus
- Prostaglandin's hypersensitivity
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Vendée
La Roche-sur-Yon, 85925
Centre Hospitalier
Le Mans
About this study
Official title: Pilot, Comparative, Not Randomized, Two Centers Study Comparing the Efficiency of Cervical Ripening BALLoon (Cook) to the DINOprostone (Propess) for the Cervical Maturation in Case of Unfavorable Cervix (Bishop <6) in the Population of Obese Pregnant Women (BMI >= 30 kg/m²)
At the moment in France, one delivery on four is induced for a medical indication. In this context, the practitioners are exposed to an additional difficulty when the clinical examination of the patient reveals a unfavorable cervix because the main drug used for the releases cannot be used and the cervix must be previously mature.
There is a pharmacological method used and estimated in these indications of cervical maturation: the dinoprostone (Propess®).
Read more
Other methods using a mechanical process, are under development and of evaluation as it is the case of the probe of dilation with double balloon (Cook®).
The population of the obese women is a population in constant increase in France and presenting deliveries to higher risks of maternal and foetal complications. At these patients, the medicinal releases seem also more difficult and at greater risks of failures.
The investigators wish compared the efficiency of the cervical ripening balloon to the dinoprostone within the framework of a medical indication in a release with a unfavorable cervix in obese pregnant women.
- Conditions
- Delivery
- Being tested
- Cervical ripening balloon, Dinoprostone
- Keywords
- unfavorable cervix, obese pregnant women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical ripening balloonDevice
Also called Cook
DinoprostoneDrug
Also called Propess
| Study group | Role | What they receive |
|---|---|---|
| Cervical ripening balloon | Experimental | Prospective Receives: Device: Cervical ripening balloon |
| Dinoprostone | Active comparator | Retrospective Receives: Drug: Dinoprostone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bishop Score After 24 Hours of Maturation
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startJun 2016
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: Delayed inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DeliveryStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume DUCARME, PH, Study director, Centre Hospitalier Departemental Vendee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649920
- Sponsor's protocol ID
- CHD019-15
- Acronym
- BALLODINO
- Status last verified
- Mar 2024
- First submitted
- 4 Jan 2016
- Last updated
- 15 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot, Comparative, Not Randomized, Two Centers Study Comparing the Efficiency of Cervical Ripening BALLoon (Cook) to the DINOprostone (Propess) for the Cervical Maturation in Case of Unfavorable Cervix (Bishop <6) in the Population of Obese Pregnant Women (BMI >= 30 kg/m²)
- ClinicalTrials.gov ID
- NCT02649920
- Acronym / sponsor ID
- BALLODINO / CHD019-15
- Conditions
- Delivery
- Keywords
- unfavorable cervix, obese pregnant women
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Delayed inclusion
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 8 Jan 2016 (estimated)
- Results
- Posted 15 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
At the moment in France, one delivery on four is induced for a medical indication. In this context, the practitioners are exposed to an additional difficulty when the clinical examination of the patient reveals a unfavorable cervix because the main drug used for the releases cannot be used and the cervix must be previously mature.
There is a pharmacological method used and estimated in these indications of cervical maturation: the dinoprostone (Propess®).
Other methods using a mechanical process, are under development and of evaluation as it is the case of the probe of dilation with double balloon (Cook®).
The population of the obese women is a population in constant increase in France and presenting deliveries to higher risks of maternal and foetal complications. At these patients, the medicinal releases seem also more difficult and at greater risks of failures.
The investigators wish compared the efficiency of the cervical ripening balloon to the dinoprostone within the framework of a medical indication in a release with a unfavorable cervix in obese pregnant women.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical ripening balloon | Experimental | Device: Cervical ripening balloonProspective |
| Dinoprostone | Active comparator | Drug: DinoprostoneRetrospective |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Term ≥ 37 weeks of amenorrhea
- Singleton pregnancy
- Cephalic presentation
- Medical indication of release and unfavorable cervix (Bishop <6)
Key exclusion criteria (23 listed)
- Age < 18 years
- Term < 37 weeks of amenorrhea
- Multiple pregnancy
- Favorable cervix (Bishop ≥ 6)
- Contraindication of vaginal delivery: praevia placenta, transverse presentation, cord prolapse
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 |
|---|---|---|
| Cervical ripening balloonAlso: Cook | Device | Cervical ripening balloon |
| DinoprostoneAlso: Propess | Drug | Dinoprostone |
Primary outcome
Bishop Score After 24 Hours of Maturation
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Guillaume DUCARME, PH study director
Centre Hospitalier Departemental Vendee
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical ripening balloon and Dinoprostone in people with Delivery, run by Centre Hospitalier Departemental Vendee at 2 sites in France.
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 8 inclusion and 23 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 15 Aug 2024. 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 France. 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?
Yes. Results are posted in the registry (first posted 15 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 After 24 Hours of Maturation (time frame: 24 hours). 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 15 Aug 2024.