Induction of Labour With a Double Balloon Catheter

NCT ID: NCT05874024

Last Updated: 2023-05-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 248 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-01-12

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.

Conditions

Labor, Induced

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Placement 6 hours

double balloon catheter placement for 6 hours

induction of labour with double balloon catheter placement for 6 hours

Intervention Type: PROCEDURE

catheter placement for 6 hours beginning in the morning at around 8 a.m.

Placement 12 hours

double balloon catheter placement for 12 hours

induction of labour with double balloon catheter placement for 12 hours

Intervention Type: PROCEDURE

catheter placement for 12 hours in the evening at around 8 p.m.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 46 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jena University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ekkehard Schleußner, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Jena University Hospital, Department of Obstetrics

Locations

Jena University Hospital

Jena, Thuringia, Germany

Countries

Germany

Other Identifiers

DBK-Trial

Identifier Type: -

Identifier Source: org_study_id