Induction of ChildbirthBAL3HNCT07492186
3-hour Versus 12-hour Double-balloon Catheter for Labor Induction
A study testing Cook® double-balloon catheter in people with Induction of Childbirth, run by Centre Hospitalier de PAU at 1 site in France.
Trial summary
This study aims to demonstrate that a 3-hour ultra-short cervical ripening protocol using a double-balloon catheter significantly reduces the induction-to-birth interval by at least 6 hours compared to the standard 12-hour protocol. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Induction of Childbirth
- What is being tested?
- Cook® double-balloon catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2027to 15 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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,
- singleton pregnancy
- ≥ 34 weeks of gestation,
- cephalic presentation,
- Bishop score < 6,
- healthy uterus,
- standard indication for labor induction
Who cannot join
- Minor patients,
- ruptured membranes,
- twin pregnancy,
- fetal malpresentation,
- placenta previa,
- previous uterine scar,
- known fetal malformation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CH de Pau
Pau, 64000
VANDEKERCKHOVE Melanie, Melanie.VANDEKERCKHOVE@ch-pau.fr
SERIS Alice, alice.seris@ch-pau.fr
About this study
Official title: Labor Induction With Double-balloon Catheter Placed for 3 Hours Versus 12 Hours in Patients With an Indication for Induction: a Randomized Controlled Trial
This study aims to demonstrate that a 3-hour ultra-short cervical ripening protocol using a double-balloon catheter significantly reduces the induction-to-birth interval by at least 6 hours compared to the standard 12-hour protocol. The study evaluates whether this reduction can be achieved without increasing cesarean section rates or maternal-fetal risks
Read the detailed description
Scientific Justification: Labor induction affects 25% of pregnancies in France, with 70% requiring cervical ripening. While the 12-hour pose is standard, recent evidence suggests that shorter durations (6h) are effective but remain difficult to integrate into hospital workflows. Since the mechanical and physiological effects of the balloon are early phenomena, a 3-hour protocol could optimize bed management and patient comfort.
Strategy: Comparison between an experimental group (3-hour balloon pose followed by immediate active labor management regardless of Bishop score) and a control group (standard 12-hour balloon pose).
Follow-up: Participants are followed from the day of induction until hospital discharge (generally 2 to 10 days) to assess obstetric outcomes, neonatal safety, and maternal satisfaction.
- Conditions
- Induction of Childbirth
- Being tested
- Cook® double-balloon catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cook® double-balloon catheterDevice
For both arms, the same double-balloon device is used. After the allocated time (3h or 12h) or spontaneous expulsion, active labor management is initiated, including early amniotomy and/or oxytocin administration
| Study group | Role | What they receive |
|---|---|---|
| 3-hour pose | Experimental | 3-hour pose of the Cook® double-balloon catheter Receives: Device: Cook® double-balloon catheter |
| 12-hour pose (standard care) | Active comparator | 12-hour pose of the Cook® double-balloon catheter (standard care) Receives: Device: Cook® double-balloon catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
induction-to-birth interval reduction
Time (in hours) between the effective initiation of labor induction (balloon insertion) and the birth of the child
Measured: balloon insertion and birth of the child
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start1 Mar 2027 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of ChildbirthStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, randomized, open-label, superiority trial with two parallel arms
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de PAU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492186
- Sponsor's protocol ID
- CHPAU2026/01
- Acronym
- BAL3H
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Labor Induction With Double-balloon Catheter Placed for 3 Hours Versus 12 Hours in Patients With an Indication for Induction: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07492186
- Acronym / sponsor ID
- BAL3H / CHPAU2026/01
- Conditions
- Induction of Childbirth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Centre Hospitalier de PAUUniversity, hospital or other
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 25 Mar 2026 (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 study aims to demonstrate that a 3-hour ultra-short cervical ripening protocol using a double-balloon catheter significantly reduces the induction-to-birth interval by at least 6 hours compared to the standard 12-hour protocol. The study evaluates whether this reduction can be achieved without increasing cesarean section rates or maternal-fetal risks
Detailed description
Scientific Justification: Labor induction affects 25% of pregnancies in France, with 70% requiring cervical ripening. While the 12-hour pose is standard, recent evidence suggests that shorter durations (6h) are effective but remain difficult to integrate into hospital workflows. Since the mechanical and physiological effects of the balloon are early phenomena, a 3-hour protocol could optimize bed management and patient comfort.
Strategy: Comparison between an experimental group (3-hour balloon pose followed by immediate active labor management regardless of Bishop score) and a control group (standard 12-hour balloon pose).
Follow-up: Participants are followed from the day of induction until hospital discharge (generally 2 to 10 days) to assess obstetric outcomes, neonatal safety, and maternal satisfaction.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, randomized, open-label, superiority trial with two parallel arms
| Arm | Type | Receives |
|---|---|---|
| 3-hour pose | Experimental | Device: Cook® double-balloon catheter3-hour pose of the Cook® double-balloon catheter |
| 12-hour pose (standard care) | Active comparator | Device: Cook® double-balloon catheter12-hour pose of the Cook® double-balloon catheter (standard care) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years,
- singleton pregnancy
- ≥ 34 weeks of gestation,
- cephalic presentation,
- Bishop score < 6,
Key exclusion criteria (7 listed)
- Minor patients,
- ruptured membranes,
- twin pregnancy,
- fetal malpresentation,
- placenta previa,
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 |
|---|---|---|
| Cook® double-balloon catheterFor both arms, the same double-balloon device is used. After the allocated time (3h or 12h) or spontaneous expulsion, active labor management is initiated, including early amniotomy and/or oxytocin administration | Device | 12-hour pose (standard care), 3-hour pose |
Primary outcome
induction-to-birth interval reduction
Time frame: balloon insertion and birth of the child
Time (in hours) between the effective initiation of labor induction (balloon insertion) and the birth of the child
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cook® double-balloon catheter in people with Induction of Childbirth, run by Centre Hospitalier de PAU at 1 site 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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 31 Mar 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
induction-to-birth interval reduction (time frame: balloon insertion and birth of the child). 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 31 Mar 2026.