Clinical trial NCT05874024: Induction of Labour With a Double Balloon Catheter
Official title: Induction of Labour With a Double Balloon Catheter - Comparison of Effectiveness of Six Versus Twelve Hours Placement: a Prospective Case Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Labor, Induced
Keywords: double balloon catheter
cervical ripening
time to delivery
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 248
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: tertiary center, women undergoing induction of labour

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.

Eligibility criteria: 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

Primary outcomes:
measure: induction to delivery interval
timeFrame: 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:
measure: number of participants with sequential drug induction of labour
timeFrame: assessd after double balloon catheter placement until time of birth, but not longer than 3 days
measure: prostaglandin to delivery interval
timeFrame: 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
measure: mode of delivery
timeFrame: after induction of labour at time of delivery
measure: blood loss during delivery
timeFrame: at time of delivery
measure: number of participants with uterine rupture
timeFrame: at time of delivery
measure: arterial umbilical pH
timeFrame: at time of delivery
measure: arterial umbilical base excess
timeFrame: at time of delivery
measure: number of participants neonatal acidosis
timeFrame: at time of delivery
measure: apgar 5 min
timeFrame: 5 minutes after delivery
measure: number of participants with pathological cardiotocography (CTG)
timeFrame: at time of labour induction
measure: number of participants with meconium-containing amniotic fluid
timeFrame: at time of delivery
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Jena University Hospital
state: Thuringe
Study officials:
affiliation: Jena University Hospital, Department of Obstetrics
name: Ekkehard Schleußner, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: