Induction of Labour With a Double Balloon Catheter

Jena University Hospital

Status: Completed

Conditions: Labor, Induced

Treatments: Procedure: induction of labour with double balloon catheter placement for 12 hours; Procedure: induction of labour with double balloon catheter placement for 6 hours

Study type: Observational

Funder types: Other

Identifiers

NCT05874024

DBK-Trial

Details and patient eligibility

About

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).

Full 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.

Enrollment: 248 patients

Sex: Female

Ages: 18 to 46 years old

Volunteers: No Healthy Volunteers

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

Trial design

248 participants in 2 patient groups

Placement 6 hours

Description:

double balloon catheter placement for 6 hours

Treatment:

Procedure: induction of labour with double balloon catheter placement for 6 hours

Placement 12 hours

Description:

double balloon catheter placement for 12 hours

Treatment:

Procedure: induction of labour with double balloon catheter placement for 12 hours