Labor, InducedNCT05874024
Induction of Labour With a Double Balloon Catheter
An observational study of Labor, Induced, run by Jena University Hospital at 1 site in Germany.
Trial summary
The objective of this study is to provide a comprehensive analysis of various time intervals (1:1). In addition to evaluating the time interval until delivery after completion of induction, the study also aims to investigate the rate of vaginal births and the type of combination therapy used (including the method of… Read more about this study
- Who is it for?
- Ages 18 to 46 years, women only
- Conditions the study is for
- Labor, Induced
- What is being tested?
- induction of labour with double balloon catheter placement for 6 hours and induction of labour with double balloon catheter placement for 12 hours
- Type of treatment
- Surgery or procedure
- How many people
- 248 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2021to 12 Jan 2023
- Phase
- Observational
- 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 to 46 years
- Women only
- No healthy volunteers
- Adult
Study population: tertiary center, women undergoing induction of labour
Who may be able to join
- destational age above or equal 37/0 weeks of gestation
- desired spontanous delivery
- Bishop-Score below or equal to 5
- cranial position
- single pregnancy
Who cannot join
- unable to consent
- pathological CTG according FIGO criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Induction of Labour With a Double Balloon Catheter - Comparison of Effectiveness of Six Versus Twelve Hours Placement: a Prospective Case Control Study
The objective of this study is to provide a comprehensive analysis of various time intervals (1:1). In addition to evaluating the time interval until delivery after completion of induction, the study also aims to investigate the rate of vaginal births and the type of combination therapy used (including the method of implementation and subsequent induction).
Read the detailed description
Approximately 22% of births in Germany are induced annually using either medicinal, mechanical, or sequential mechanical/medicinal methods, with oxytocin and prostaglandins being the available drug options. Double balloon catheters have been used in clinics for over a decade for mechanical induction of labour, resulting in cervical ripening and possible onset of labour through endogenous prostaglandin release. This method is associated with low rates of uterine tachysystole and maternal and neonatal morbidity.
The recommended placement time for the double balloon catheter is 12 hours, typically performed at night in an inpatient setting, which may cause early exhaustion and fatigue for patients. However, a study has shown that a shorter insertion time of 6 hours is equally safe and effective, without any time savings beyond the shortened insertion time.
This study aims to investigate the feasibility and effectiveness of shortening the induction birth interval from 12 to 6 hours. The investigators hypothesize that this will result in a shorter induction birth interval with comparable maternal and neonatal outcomes. This analysis will test the effectiveness of the shortened induction birth interval.
- Conditions
- Labor, Induced
- Being tested
- induction of labour with double balloon catheter placement for 6 hours, induction of labour with double balloon catheter placement for 12 hours
- Keywords
- double balloon catheter, cervical ripening, time to delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
induction of labour with double balloon catheter placement for 6 hoursProcedure or surgery
catheter placement for 6 hours beginning in the morning at around 8 a.m.
induction of labour with double balloon catheter placement for 12 hoursProcedure or surgery
catheter placement for 12 hours in the evening at around 8 p.m.
| Study group | Role | What they receive |
|---|---|---|
| Placement 6 hours | double balloon catheter placement for 6 hours Receives: Procedure: induction of labour with double balloon catheter placement for 6 hours | |
| Placement 12 hours | double balloon catheter placement for 12 hours Receives: Procedure: induction of labour with double balloon catheter placement for 12 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
induction to delivery interval
the induction to delivery interval measured in minutes
Measured: From date and time of beginning of labour induction to date and time of birth, assessed as long as needed, but not longer than 5 days
Secondary outcomes (11)
number of participants with sequential drug induction of labour
the need for additional drugs for inductionof labour after the assigned placement time of the double balloon catheter
Measured: assessd after double balloon catheter placement until time of birth, but not longer than 3 days
prostaglandin to delivery interval
the prostaglandin to delivery interval measured in minutes
Measured: From date and time of beginning of prostaglandin treatment to date and time of birth, assessed as long as needed, but not longer than 3 days
mode of delivery
resulting mode of delivery after induction of labour expressed as spontaneous vaginal, vaginal operative or caesarean section
Measured: after induction of labour at time of delivery
blood loss during delivery
maternal outcome blood loss during delivery in ml
Measured: at time of delivery
number of participants with uterine rupture
maternal outcome uterine rupture
Measured: at time of delivery
arterial umbilical pH
neonatal outcome arterial umbilical pH measured directly after delivery
Measured: at time of delivery
arterial umbilical base excess
neonatal outcome arterial umbilical base excess measured directly after delivery
Measured: at time of delivery
number of participants neonatal acidosis
neonatal outcome arterial umbilical pH < 7.1
Measured: at time of delivery
apgar 5 min
neonatal outcome apgar 5 min (A- appearance, P-Pulse, G- grimace, A- activity, R-respiration) with a range between 0-10 with higher values as better outcome
Measured: 5 minutes after delivery
number of participants with pathological cardiotocography (CTG)
neonatal outcome pathological CTG (cardiotocography) at time of labour induction
Measured: at time of labour induction
number of participants with meconium-containing amniotic fluid
neonatal outcome meconium-containing amniotic fluid measured as visible green stained amniotic fluid at time of delivery
Measured: at time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 Jan 2021
- Primary completion31 Dec 2021
- Study completion12 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor, InducedStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ekkehard Schleußner, Prof. Dr., Principal investigator, Jena University Hospital, Department of Obstetrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874024
- Sponsor's protocol ID
- DBK-Trial
- Status last verified
- Apr 2023
- First submitted
- 13 Apr 2023
- Last updated
- 24 May 2023
- Results posted
- 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 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Labour With a Double Balloon Catheter - Comparison of Effectiveness of Six Versus Twelve Hours Placement: a Prospective Case Control Study
- ClinicalTrials.gov ID
- NCT05874024
- Acronym / sponsor ID
- DBK-Trial
- Conditions
- Labor, Induced
- Keywords
- double balloon catheter, cervical ripening, time to delivery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 12 Jan 2023 (actual)
- First posted
- 24 May 2023 (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.
The objective of this study is to provide a comprehensive analysis of various time intervals (1:1). In addition to evaluating the time interval until delivery after completion of induction, the study also aims to investigate the rate of vaginal births and the type of combination therapy used (including the method of implementation and subsequent induction).
Detailed description
Approximately 22% of births in Germany are induced annually using either medicinal, mechanical, or sequential mechanical/medicinal methods, with oxytocin and prostaglandins being the available drug options. Double balloon catheters have been used in clinics for over a decade for mechanical induction of labour, resulting in cervical ripening and possible onset of labour through endogenous prostaglandin release. This method is associated with low rates of uterine tachysystole and maternal and neonatal morbidity.
The recommended placement time for the double balloon catheter is 12 hours, typically performed at night in an inpatient setting, which may cause early exhaustion and fatigue for patients. However, a study has shown that a shorter insertion time of 6 hours is equally safe and effective, without any time savings beyond the shortened insertion time.
This study aims to investigate the feasibility and effectiveness of shortening the induction birth interval from 12 to 6 hours. The investigators hypothesize that this will result in a shorter induction birth interval with comparable maternal and neonatal outcomes. This analysis will test the effectiveness of the shortened induction birth interval.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placement 6 hours | – | Procedure: induction of labour with double balloon catheter placement for 6 hoursdouble balloon catheter placement for 6 hours |
| Placement 12 hours | – | Procedure: induction of labour with double balloon catheter placement for 12 hoursdouble balloon catheter placement for 12 hours |
Who may qualify
- Ages
- 18 to 46 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- tertiary center, women undergoing induction of labour
Key inclusion criteria (5 listed)
- destational age above or equal 37/0 weeks of gestation
- desired spontanous delivery
- Bishop-Score below or equal to 5
- cranial position
- single pregnancy
Key exclusion criteria (2 listed)
- unable to consent
- pathological CTG according FIGO criteria
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 |
|---|---|---|
| induction of labour with double balloon catheter placement for 6 hourscatheter placement for 6 hours beginning in the morning at around 8 a.m. | Procedure or surgery | Placement 6 hours |
| induction of labour with double balloon catheter placement for 12 hourscatheter placement for 12 hours in the evening at around 8 p.m. | Procedure or surgery | Placement 12 hours |
Primary outcome
induction to delivery interval
Time frame: From date and time of beginning of labour induction to date and time of birth, assessed as long as needed, but not longer than 5 days
the induction to delivery interval measured in minutes
11 secondary outcomes
number of participants with sequential drug induction of labour
Time frame: assessd after double balloon catheter placement until time of birth, but not longer than 3 days
prostaglandin to delivery interval
Time frame: From date and time of beginning of prostaglandin treatment to date and time of birth, assessed as long as needed, but not longer than 3 days
mode of delivery
Time frame: after induction of labour at time of delivery
blood loss during delivery
Time frame: at time of delivery
number of participants with uterine rupture
Time frame: at time of delivery
arterial umbilical pH
Time frame: at time of delivery
arterial umbilical base excess
Time frame: at time of delivery
number of participants neonatal acidosis
Time frame: at time of delivery
apgar 5 min
Time frame: 5 minutes after delivery
number of participants with pathological cardiotocography (CTG)
Time frame: at time of labour induction
number of participants with meconium-containing amniotic fluid
Time frame: at time of 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 24 May 2023.
- 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. This study is not recruiting at the moment.
Ekkehard Schleußner, Prof. Dr. principal investigator
Jena University Hospital, Department of Obstetrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor, Induced, run by Jena University Hospital at 1 site in Germany.
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 5 inclusion and 2 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 24 May 2023. 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 Germany. 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?
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?
induction to delivery interval (time frame: From date and time of beginning of labour induction to date and time of birth, assessed as long as needed, but not longer than 5 days). 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 24 May 2023.