PregnancyPhase 3LINCT00602095
Labour Induction With Misoprostol, Dinoprostone and Bard Catheter
A Phase 3 study testing misoprostol, dinoprostone and Bard Catheter (balloon catheter) in people with Pregnancy, run by Karolinska University Hospital.
Trial summary
This is a randomised study aimed at comparing the currently most frequently used prostaglandin dinoprostone to two other methods, the cheaper and perhaps more effective prostaglandin misoprostol and a transcervical catheter. 592 women were recruited and randomised to one of the three methods. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- misoprostol, dinoprostone and Bard Catheter (balloon catheter)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 592 participants
- Where
- No sites listed yet
- Study dates
- Dec 2004to Mar 2007
- Phase
- Phase 3
- 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
- Full term singleton pregnancy with vertex presentation and with an indication for labour induction.
- Absence of active labour
- Bishop score ≤ 6.
- Normal CTG registration
Who cannot join
- Previous cesarean section
- signs of infection
- immediate need for delivery
- any contraindication for vaginal delivery
About this study
Official title: A Randomised Comparison Between Intravaginal Dinoprostone Intravaginal Misoprostol and Transcervical Balloon Catheter for Labour Induction
This is a randomised study aimed at comparing the currently most frequently used prostaglandin dinoprostone to two other methods, the cheaper and perhaps more effective prostaglandin misoprostol and a transcervical catheter. 592 women were recruited and randomised to one of the three methods. The main outcome measures were time to delivery, rate of instrumental deliveries and maternal neonatal outcome. Our hypothesis was that misoprostol would be superior to the other methods.
The main finding of our trial was that the catheter showed the shortest induction to delivery interval. There were no differences between the two other prostaglandins. No differences in maternal and neonatal outcome was found
- Conditions
- Pregnancy
- Being tested
- misoprostol, dinoprostone, Bard Catheter (balloon catheter)
- Keywords
- Labor induction, cervical ripening, misoprostol, dinoprostone, balloon catheter, prostaglandin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
misoprostolDrug
Also called Cytotec, one quarter of a 0.100mg tablet
0.025mg tablet vaginally every 4 hour until progress
dinoprostoneDrug
Also called Minprostin
2mg vaginal gel every 6 hours until progress
Bard Catheter (balloon catheter)Device
Also called Bard Catheter
Intracervical balloon catheter positioned above internal cervical os and filled with sterile water. Removed when cervix was dilated
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Labour induction with misoprostol Receives: Drug: misoprostol |
| 2 | Active comparator | Labour induction with dinoprostone Receives: Drug: dinoprostone |
| 3 | Experimental | Labour induction with bard Receives: Device: Bard Catheter (balloon catheter) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from treatment start to delivery
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startDec 2004
- Primary completionMar 2007
- Study completionMar 2007
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 PregnancyStudies of the same condition, open and under way.
- More trials run by Karolinska 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 592 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Lena Marions, MD PhD, Principal investigator, Karolinska University Hospital Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00602095
- Sponsor's protocol ID
- LMS2007
- Other IDs
- KS2007
- Acronym
- LI
- Status last verified
- Jan 2008
- First submitted
- 2 Jan 2008
- Last updated
- 28 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
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 28 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Comparison Between Intravaginal Dinoprostone Intravaginal Misoprostol and Transcervical Balloon Catheter for Labour Induction
- ClinicalTrials.gov ID
- NCT00602095
- Acronym / sponsor ID
- LI / LMS2007
- Conditions
- Pregnancy
- Keywords
- Labor induction, cervical ripening, misoprostol, dinoprostone, balloon catheter, prostaglandin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 592 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 28 Jan 2008 (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.
This is a randomised study aimed at comparing the currently most frequently used prostaglandin dinoprostone to two other methods, the cheaper and perhaps more effective prostaglandin misoprostol and a transcervical catheter. 592 women were recruited and randomised to one of the three methods. The main outcome measures were time to delivery, rate of instrumental deliveries and maternal neonatal outcome. Our hypothesis was that misoprostol would be superior to the other methods.
The main finding of our trial was that the catheter showed the shortest induction to delivery interval. There were no differences between the two other prostaglandins. No differences in maternal and neonatal outcome was found
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: misoprostolLabour induction with misoprostol |
| 2 | Active comparator | Drug: dinoprostoneLabour induction with dinoprostone |
| 3 | Experimental | Device: Bard Catheter (balloon catheter)Labour induction with bard |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Full term singleton pregnancy with vertex presentation and with an indication for labour induction.
- Absence of active labour
- Bishop score ≤ 6.
- Normal CTG registration
Key exclusion criteria (4 listed)
- Previous cesarean section
- signs of infection
- immediate need for delivery
- any contraindication for vaginal delivery
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 |
|---|---|---|
| misoprostolAlso: Cytotec, one quarter of a 0.100mg tablet0.025mg tablet vaginally every 4 hour until progress | Drug | 1 |
| dinoprostoneAlso: Minprostin2mg vaginal gel every 6 hours until progress | Drug | 2 |
| Bard Catheter (balloon catheter)Also: Bard CatheterIntracervical balloon catheter positioned above internal cervical os and filled with sterile water. Removed when cervix was dilated | Device | 3 |
Primary outcome
Time from treatment start to delivery
Time frame: At delivery
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 28 Jan 2008.
- 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.
Lena Marions, MD PhD principal investigator
Karolinska University Hospital Institute
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing misoprostol, dinoprostone and Bard Catheter (balloon catheter) in people with Pregnancy, run by Karolinska University Hospital.
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 4 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 28 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Time from treatment start to delivery (time frame: At delivery). 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 NCT00602095, 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 28 Jan 2008.