NCT05874024

Induction of Labour With a Double Balloon Catheter

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 248 (actual)
• Sponsor: Jena University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 46 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Labor, Induced

Interventions

Type	Name	Description
PROCEDURE	induction of labour with double balloon catheter placement for 6 hours	catheter placement for 6 hours beginning in the morning at around 8 a.m.
PROCEDURE	induction of labour with double balloon catheter placement for 12 hours	catheter placement for 12 hours in the evening at around 8 p.m.

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-12-31
• Completion: 2023-01-12
• First posted: 2023-05-24
• Last updated: 2023-05-24

Locations

1 site across 1 country: Germany