Labor, Induced
Conditions
Keywords
double balloon catheter, cervical ripening, time to delivery
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.
Interventions
PROCEDUREinduction of labour with double balloon catheter placement for 6 hours
catheter placement for 6 hours beginning in the morning at around 8 a.m.
PROCEDUREinduction of labour with double balloon catheter placement for 12 hours
catheter placement for 12 hours in the evening at around 8 p.m.
Sponsors
Jena University Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 46 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| blood loss during delivery | at time of delivery | maternal outcome blood loss during delivery in ml |
| number of participants with uterine rupture | at time of delivery | maternal outcome uterine rupture |
| arterial umbilical pH | at time of delivery | neonatal outcome arterial umbilical pH measured directly after 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 | the need for additional drugs for inductionof labour after the assigned placement time of the double balloon catheter |
| number of participants neonatal acidosis | at time of delivery | neonatal outcome arterial umbilical pH \< 7.1 |
| 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 |
| number of participants with pathological cardiotocography (CTG) | at time of labour induction | neonatal outcome pathological CTG (cardiotocography) at time of labour induction |
| 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 |
| arterial umbilical base excess | at time of delivery | neonatal outcome arterial umbilical base excess measured directly after delivery |
Countries
Germany
Outcome results
None listed