Induction of BirthPhase 4NCT01091285
Induction of Labor With Single and Double Balloon Catheters, a Randomized Controlled Study
A Phase 4 study testing Foley Catheter and Double Balloon Catheter in people with Induction of Birth, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
A randomized controlled double blinded study to investigate whether a specially designed double balloon catheter is more efficient than a foley catheter for cervical ripening and induction of birth. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Induction of Birth
- What is being tested?
- Foley Catheter and Double Balloon Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2010to Jan 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Singleton pregnancy above week 37
- Indication to induce birth
- Unripe cervix
- Term date set by US before week 21
Who cannot join
- Ripe cervix
- Prematurity (<37w)
- IUFD
- Letal malformations
- Low lying placenta
- Multiple pregnancies
- Breakage of amniotic fluid
- The woman does not understand norwegian
Trial locations and contacts
1 site in 1 country.
About this study
A randomized controlled double blinded study to investigate whether a specially designed double balloon catheter is more efficient than a foley catheter for cervical ripening and induction of birth.
160 women with singleton term pregnancies with un ripe cervix and no contraindications for catheters will be included and randomized to either double og single balloon catheters for cervical ripening. Efficacy wil be assessed at removal of the catheter, measured by the amount of women where the cervix has become ripe enough for amniotomy.
Our hypothesis is that double balloon catheters will give a greater amount of women where amniotomy upon catheter removal is possible. Secondary outcomes as time from induction till birth, vaginal deliveries and complications during or after birth for the mother or child will also become recorded.
- Conditions
- Induction of Birth
- Being tested
- Foley Catheter, Double Balloon Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foley CatheterDevice
Foley Catheter 16-19 H
Double Balloon CatheterDevice
Also called Cervical Ripening Balloon, Cook Medical
Double Balloon Catheter for 16-19H
| Study group | Role | What they receive |
|---|---|---|
| Single Balloon Catheter | Active comparator | Cervix Ripening is achieved by a single balloon catheter. Further induction by cytotec or/amniotomy and pitocin Receives: Device: Foley Catheter |
| Double balloon catheter | Active comparator | Cervix Ripening is achieved by a double balloon catheter. Further induction by cytotec or/amniotomy and pitocin Receives: Device: Double Balloon Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervix dilatation >= 3cm
Cervix dilatation is assessed by vaginally examination at Catheter removal.
Measured: At cather removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJan 2011
- Study completionJan 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 Induction of BirthStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091285
- Sponsor's protocol ID
- 1728a (REK)
- Status last verified
- Apr 2010
- First submitted
- 20 Mar 2010
- Last updated
- 17 Aug 2011
- Results posted
- 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 17 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Labor With Single and Double Balloon Catheters, a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01091285
- Acronym / sponsor ID
- 1728a (REK)
- Conditions
- Induction of Birth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 24 Mar 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.
A randomized controlled double blinded study to investigate whether a specially designed double balloon catheter is more efficient than a foley catheter for cervical ripening and induction of birth.
160 women with singleton term pregnancies with un ripe cervix and no contraindications for catheters will be included and randomized to either double og single balloon catheters for cervical ripening. Efficacy wil be assessed at removal of the catheter, measured by the amount of women where the cervix has become ripe enough for amniotomy.
Our hypothesis is that double balloon catheters will give a greater amount of women where amniotomy upon catheter removal is possible. Secondary outcomes as time from induction till birth, vaginal deliveries and complications during or after birth for the mother or child will also become recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Balloon Catheter | Active comparator | Device: Foley CatheterCervix Ripening is achieved by a single balloon catheter. Further induction by cytotec or/amniotomy and pitocin |
| Double balloon catheter | Active comparator | Device: Double Balloon CatheterCervix Ripening is achieved by a double balloon catheter. Further induction by cytotec or/amniotomy and pitocin |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Singleton pregnancy above week 37
- Indication to induce birth
- Unripe cervix
- Term date set by US before week 21
Key exclusion criteria (8 listed)
- Ripe cervix
- Prematurity (<37w)
- IUFD
- Letal malformations
- Low lying placenta
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 |
|---|---|---|
| Foley CatheterFoley Catheter 16-19 H | Device | Single Balloon Catheter |
| Double Balloon CatheterAlso: Cervical Ripening Balloon, Cook MedicalDouble Balloon Catheter for 16-19H | Device | Double balloon catheter |
Primary outcome
Cervix dilatation >= 3cm
Time frame: At cather removal
Cervix dilatation is assessed by vaginally examination at Catheter removal.
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 17 Aug 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 Foley Catheter and Double Balloon Catheter in people with Induction of Birth, run by Haukeland University Hospital at 1 site in Norway.
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 4 inclusion and 8 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 17 Aug 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 Norway. 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?
Cervix dilatation >= 3cm (time frame: At cather removal). 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 NCT01091285, 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 17 Aug 2011.