Induction of Labour With a Double Balloon Catheter
- Conditions
- Labor, Induced
- Interventions
- Procedure: induction of labour with double balloon catheter placement for 12 hoursProcedure: induction of labour with double balloon catheter placement for 6 hours
- Registration Number
- NCT05874024
- Lead Sponsor
- Jena University Hospital
- Brief 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 248
- destational age above or equal 37/0 weeks of gestation
- desired spontanous delivery
- Bishop-Score below or equal to 5
- cranial position
- single pregnancy
- unable to consent
- pathological CTG according FIGO criteria
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Placement 12 hours induction of labour with double balloon catheter placement for 12 hours double balloon catheter placement for 12 hours Placement 6 hours induction of labour with double balloon catheter placement for 6 hours double balloon catheter placement for 6 hours
- Primary Outcome Measures
Name Time Method induction to delivery interval 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
- Secondary Outcome Measures
Name Time Method blood loss during delivery at time of delivery maternal outcome blood loss during delivery in ml
mode of delivery after induction of labour at time of delivery resulting mode of delivery after induction of labour expressed as spontaneous vaginal, vaginal operative or caesarean section
number of participants with sequential drug induction of labour assessd after double balloon catheter placement until time of birth, but not longer than 3 days the need for additional drugs for inductionof labour after the assigned placement time of the double balloon catheter
arterial umbilical pH at time of delivery neonatal outcome arterial umbilical pH measured directly after delivery
number of participants with uterine rupture at time of delivery maternal outcome uterine rupture
number of participants with meconium-containing amniotic fluid at time of delivery neonatal outcome meconium-containing amniotic fluid measured as visible green stained amniotic fluid at time of delivery
prostaglandin to delivery interval 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 the prostaglandin to delivery interval measured in minutes
arterial umbilical base excess at time of delivery neonatal outcome arterial umbilical base excess measured directly after delivery
number of participants neonatal acidosis at time of delivery neonatal outcome arterial umbilical pH \< 7.1
number of participants with pathological cardiotocography (CTG) at time of labour induction neonatal outcome pathological CTG (cardiotocography) at time of labour induction
apgar 5 min 5 minutes after delivery 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
Trial Locations
- Locations (1)
Jena University Hospital
🇩🇪Jena, Thuringe, Germany