Induction TimePhase 4NCT01255839
The Balloon Project for Birth Induction
A Phase 4 study testing Double Balloon and Minprostin in people with Induction Time and Apgar Score, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
The use of prostaglandin E2 (PGE2) for induction of labour in women with unfavourable cervices is well-established1. There are, however, potential side effects to prostaglandins, in particular the risk of uterine hypertonicity which may affect fetal outcome. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Induction Time, Apgar Score, Admission to Neonatal Unit
- What is being tested?
- Double Balloon and Minprostin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 825 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2002to Dec 2010
- 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
- pregnancies with intact fetal membranes
- vertex position
- unripe cervix Bishop score < 6)
- usual indications for induction of labour, i.e. prolonged pregnancy, pre-eclampsia/ hyper-tension, placental insufficiency, diabetes mellitus and twins
Who cannot join
- Spontaneous labour or rupture of membranes
- placenta previa
- acute fetal distress
- specific infections vagina/cervix (GBS, condyloma, acute herpes)
- asthma
- glaucoma
- allergy to latex
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Glostrup University Hospital
Glostrup Municipality, Glostrup, 2600
About this study
Official title: A Prospective Multi-centre Randomised Comparison on Induction of Labour With Double-balloon Installation Device Versus Prostaglandin E2 Minprostin
The use of prostaglandin E2 (PGE2) for induction of labour in women with unfavourable cervices is well-established1. There are, however, potential side effects to prostaglandins, in particular the risk of uterine hypertonicity which may affect fetal outcome. In theory a mechanical ripening based on dilatation of the cervix as well as induction of production of endogenous prostaglandin has potentially less influence on the fetal outcome but a Cochrane review from 2001 scrutinized studies on mechanical ripening versus placebo/no treatment or prostaglandin E2. They conclude there is insufficient data to evaluate the effectiveness in terms of likelihood of vaginal delivery in 24 hours, and emphasise the need for large sample size studies and substantive outcomes. Two later randomised studies compared mechanical ripening to PGE2 and found discrepant results regarding time from induction to delivery.
The primary purpose of the present study was in a randomized design to compare the efficacy of double-balloon catheter versus vaginal PGE2 (minprostin 3 mg) on induction of labour, duration of birth and fetal outcome. Secondary analyses were to evaluate the results for various subgroups, i.e. primipara/multipara, gemelli, vaginal birth after caesarean, preterm birth and intra uterine growth restriction.
Read the detailed description
The study was a multicenter randomized study conducted at 7 labour yards in Denmark (Glostrup, Hillerød, Svendborg, Rigshospitalet, Næstved, Frederiksberg and Hvidovre). Participants were included from December 11 2002 till September 29 2005 after approval from The Danish National Committee on Biomedical Research Ethics and the data legislation. All participants were included after written and oral informed consent.
Eligible for inclusion were pregnancies with intact fetal membranes, vertex position and unripe cervix (Bishop score < 6) who had usual indications for induction of labour, i.e. prolonged pregnancy, pre-eclampsia/ hyper-tension, placental insufficiency, diabetes mellitus and twins.
Women were excluded under the following circumstances: Spontaneous labour or rupture of membranes, placenta previa, acute fetal distress, specific infections vagina/cervix (GBS, condyloma, acute herpes), asthma, glaucoma and allergy to latex. The participants were randomised to treatment arm by 'telephonic automatic voice response system randomisation'.
Induction of labour methods The balloon group The Double Balloon Catheter was applied (Atad 5) with 80 ml NaCl installed intrauterine above the intern orificium and 80 ml below in cervix/vagina. The Balloon catheter was inserted in the evening (8-9 p.m.) if the Bishop-score was below 6, however if the score was above 6 or the insertion was impossible the participant was considered failure. The catheter was removed after 12 h (or before if needed). The labour induction was continued by amniotomy either directly or after 2 hours mobilisation and laxative or after additional 2 hours of intravenous syntocinon drip. If by then amniotomy was not possible the participant was considered failure. After amniotomy if necessary for progression of contractions intravenous oxytocin-drip was started for 2-3 hours (figure 1). If further induction was necessary the participant was considered failure.
The minprostin group The prostaglandin 2 minprostin (3mg) was applied vaginally in the morning the day of induction if Bishop score was 6 or below. After 4-5 hours a second minprostin was inserted if amniotomy was not possible. If the labour was not induced the first day the procedure it was repeated the following day. If labour was not established within 48 hours after the first minprostin the participant was considered failure.
- Conditions
- Induction Time, Apgar Score, Admission to Neonatal Unit, Vaginal Delivery, Caesarean Section
- Being tested
- Double Balloon, Minprostin
- Keywords
- double-balloon, balloon catheter, prostaglandin, minprostin, induction of labour, fetal outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double BalloonDevice
The Double Balloon Catheter was applied (Atad 5) with 80 ml NaCl installed intrauterine above the intern orificium and 80 ml below in cervix/vagina.
MinprostinDrug
The prostaglandin 2 minprostin (3mg) was applied vaginally
| Study group | Role | What they receive |
|---|---|---|
| Double-balloon | Active comparator | The Double Balloon Catheter was applied (Atad 5) with 80 ml NaCl installed intrauterine above the intern orificium and 80 ml below in cervix/vagina. Receives: Device: Double Balloon |
| Prostglandin E2 | Active comparator | The prostaglandin 2 minprostin (3mg) was applied vaginally Receives: Drug: Minprostin |
What is being measured
The primary outcome is the main question the study is designed to answer.
success of induction of labour, duration of birth and fetal outcome
The primary purpose of the present study was in a randomized design to compare the efficacy of double-balloon catheter versus vaginal PGE2 (minprostin 3 mg) .
Measured: at birth
Secondary outcomes (1)
the results for various subgroups, i.e. primipara/multipara, gemelli, vaginal birth after caesarean, preterm birth and intra uterine growth restriction
Measured: at birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study startDec 2002
- Primary completionSep 2005
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction TimeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 825 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255839
- Sponsor's protocol ID
- H-KA-01177-M
- Status last verified
- Jan 2002
- First submitted
- 6 Dec 2010
- Last updated
- 8 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-centre Randomised Comparison on Induction of Labour With Double-balloon Installation Device Versus Prostaglandin E2 Minprostin
- ClinicalTrials.gov ID
- NCT01255839
- Acronym / sponsor ID
- H-KA-01177-M
- Conditions
- Induction Time, Apgar Score, Admission to Neonatal Unit, Vaginal Delivery, Caesarean Section
- Keywords
- double-balloon, balloon catheter, prostaglandin, minprostin, induction of labour, fetal outcome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 825 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Dec 2002
- Primary completion
- Sep 2005 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 8 Dec 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.
The use of prostaglandin E2 (PGE2) for induction of labour in women with unfavourable cervices is well-established1. There are, however, potential side effects to prostaglandins, in particular the risk of uterine hypertonicity which may affect fetal outcome. In theory a mechanical ripening based on dilatation of the cervix as well as induction of production of endogenous prostaglandin has potentially less influence on the fetal outcome but a Cochrane review from 2001 scrutinized studies on mechanical ripening versus placebo/no treatment or prostaglandin E2. They conclude there is insufficient data to evaluate the effectiveness in terms of likelihood of vaginal delivery in 24 hours, and emphasise the need for large sample size studies and substantive outcomes. Two later randomised studies compared mechanical ripening to PGE2 and found discrepant results regarding time from induction to delivery.
The primary purpose of the present study was in a randomized design to compare the efficacy of double-balloon catheter versus vaginal PGE2 (minprostin 3 mg) on induction of labour, duration of birth and fetal outcome. Secondary analyses were to evaluate the results for various subgroups, i.e. primipara/multipara, gemelli, vaginal birth after caesarean, preterm birth and intra uterine growth restriction.
Detailed description
The study was a multicenter randomized study conducted at 7 labour yards in Denmark (Glostrup, Hillerød, Svendborg, Rigshospitalet, Næstved, Frederiksberg and Hvidovre). Participants were included from December 11 2002 till September 29 2005 after approval from The Danish National Committee on Biomedical Research Ethics and the data legislation. All participants were included after written and oral informed consent.
Eligible for inclusion were pregnancies with intact fetal membranes, vertex position and unripe cervix (Bishop score < 6) who had usual indications for induction of labour, i.e. prolonged pregnancy, pre-eclampsia/ hyper-tension, placental insufficiency, diabetes mellitus and twins.
Women were excluded under the following circumstances: Spontaneous labour or rupture of membranes, placenta previa, acute fetal distress, specific infections vagina/cervix (GBS, condyloma, acute herpes), asthma, glaucoma and allergy to latex. The participants were randomised to treatment arm by 'telephonic automatic voice response system randomisation'.
Induction of labour methods The balloon group The Double Balloon Catheter was applied (Atad 5) with 80 ml NaCl installed intrauterine above the intern orificium and 80 ml below in cervix/vagina. The Balloon catheter was inserted in the evening (8-9 p.m.) if the Bishop-score was below 6, however if the score was above 6 or the insertion was impossible the participant was considered failure. The catheter was removed after 12 h (or before if needed). The labour induction was continued by amniotomy either directly or after 2 hours mobilisation and laxative or after additional 2 hours of intravenous syntocinon drip. If by then amniotomy was not possible the participant was considered failure. After amniotomy if necessary for progression of contractions intravenous oxytocin-drip was started for 2-3 hours (figure 1). If further induction was necessary the participant was considered failure.
The minprostin group The prostaglandin 2 minprostin (3mg) was applied vaginally in the morning the day of induction if Bishop score was 6 or below. After 4-5 hours a second minprostin was inserted if amniotomy was not possible. If the labour was not induced the first day the procedure it was repeated the following day. If labour was not established within 48 hours after the first minprostin the participant was considered failure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double-balloon | Active comparator | Device: Double BalloonThe Double Balloon Catheter was applied (Atad 5) with 80 ml NaCl installed intrauterine above the intern orificium and 80 ml below in cervix/vagina. |
| Prostglandin E2 | Active comparator | Drug: MinprostinThe prostaglandin 2 minprostin (3mg) was applied vaginally |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- pregnancies with intact fetal membranes
- vertex position
- unripe cervix Bishop score < 6)
- usual indications for induction of labour, i.e. prolonged pregnancy, pre-eclampsia/ hyper-tension, placental insufficiency, diabetes mellitus and twins
Key exclusion criteria (7 listed)
- Spontaneous labour or rupture of membranes
- placenta previa
- acute fetal distress
- specific infections vagina/cervix (GBS, condyloma, acute herpes)
- asthma
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 BalloonThe Double Balloon Catheter was applied (Atad 5) with 80 ml NaCl installed intrauterine above the intern orificium and 80 ml below in cervix/vagina. | Device | Double-balloon |
| MinprostinThe prostaglandin 2 minprostin (3mg) was applied vaginally | Drug | Prostglandin E2 |
Primary outcome
success of induction of labour, duration of birth and fetal outcome
Time frame: at birth
The primary purpose of the present study was in a randomized design to compare the efficacy of double-balloon catheter versus vaginal PGE2 (minprostin 3 mg) .
1 secondary outcome
the results for various subgroups, i.e. primipara/multipara, gemelli, vaginal birth after caesarean, preterm birth and intra uterine growth restriction
Time frame: at birth
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 8 Dec 2010.
Related trials for Induction Time
Active, not recruiting
Calcium Carbonate on Labor Induction
Pregnancy, Uterine Contraction
RecruitingPhase 4
A Novel Two-Step Dosing Induction Strategy (The Propofol Challenge Test) to Minimize Propofol Injection Pain
Any Patient Under General Anesthesia With Propofol Induction
RecruitingPhase 4
Time to Loss of Consciousness With Remimazolam Versus Propofol for Anesthetic Induction in Laparoscopic Cholecystectomy
Intravenous Anesthesia, Cholelithiasis
Recruiting
Cannabis Association With Sleep Study
Sleep
Recruiting
Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
Cardiac Arrest, Out-Of-Hospital, Hypothermia, Induced
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 and Minprostin in people with Induction Time and Apgar Score, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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 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: finished, as of the sponsor's last update on 8 Dec 2010. 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 Denmark. 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?
success of induction of labour, duration of birth and fetal outcome (time frame: at birth). 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 8 Dec 2010.