Induction of Labour With a Double Balloon Catheter - Comparison of Effectiveness of Six Versus Twelve Hours Placement: a Prospective Case Control Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Jena University Hospital
- Enrollment
- 248
- Locations
- 1
- Primary Endpoint
- induction to delivery interval
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 46 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- blood loss during delivery(at time of delivery)
- mode of delivery(after induction of labour at time of delivery)
- 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)
- number of participants with uterine rupture(at time of delivery)
- arterial umbilical pH(at time of delivery)
- number of participants with meconium-containing 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)
- arterial umbilical base excess(at time of delivery)
- number of participants neonatal acidosis(at time of delivery)
- number of participants with pathological cardiotocography (CTG)(at time of labour induction)
- apgar 5 min(5 minutes after delivery)