Induction of Labour With a Double Balloon Catheter

Study Overview
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Brief Summary
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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
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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.

Official Title
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Induction of Labour With a Double Balloon Catheter - Comparison of Effectiveness of Six Versus Twelve Hours Placement: a Prospective Case Control Study

Conditions
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Labor, Induced

Intervention / Treatment
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* Procedure: induction of labour with double balloon catheter placement for 6 hours
* Procedure: induction of labour with double balloon catheter placement for 12 hours


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: destational age above or equal 37/0 weeks of gestation desired spontanous delivery Bishop-Score below or equal to 5 cranial position single pregnancy Exclusion Criteria: unable to consent pathological CTG according FIGO criteria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 46 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placement 6 hours<br>double balloon catheter placement for 6 hours | Procedure: induction of labour with double balloon catheter placement for 6 hours<br>* catheter placement for 6 hours beginning in the morning at around 8 a.m.<br>|
| Placement 12 hours<br>double balloon catheter placement for 12 hours | Procedure: induction of labour with double balloon catheter placement for 12 hours<br>* catheter placement for 12 hours in the evening at around 8 p.m.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| induction to delivery interval | the induction to delivery interval measured in minutes | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | after induction of labour at time of delivery | 
| blood loss during delivery | maternal outcome blood loss during delivery in ml | at time of delivery | 
| number of participants with uterine rupture | maternal outcome uterine rupture | at time of delivery | 
| arterial umbilical pH | neonatal outcome arterial umbilical pH measured directly after delivery | at time of delivery | 
| arterial umbilical base excess | neonatal outcome arterial umbilical base excess measured directly after delivery | at time of delivery | 
| number of participants neonatal acidosis | neonatal outcome arterial umbilical pH < 7.1 | 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 | 5 minutes after delivery | 
| number of participants with pathological cardiotocography (CTG) | neonatal outcome pathological CTG (cardiotocography) at time of labour induction | 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 | at time of delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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double balloon catheter, cervical ripening, time to delivery