Induction of Labour With a Double Balloon Catheter

NCT05874024 | Completed

• 1 other identifier: DBK-Trial
• Study Type: observational
• Target: 248
• Locations: 1 country
• Sites: 1

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).

Conditions

Labor, Induced

Keywords

double balloon catheter; cervical ripening; time to delivery

Outcome Measures

Primary Outcomes (1)

• induction to delivery interval

  the induction to delivery interval measured in minutes

  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 (11)

• 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

• 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

• mode of delivery

  after induction of labour at time of delivery

• blood loss during delivery

  at time of delivery

• number of participants with uterine rupture

  at time of delivery

Study Arms (2)

Placement 6 hours

double balloon catheter placement for 6 hours

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

Placement 12 hours

double balloon catheter placement for 12 hours

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

Interventions

induction of labour with double balloon catheter placement for 6 hours PROCEDURE

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

Placement 6 hours

induction of labour with double balloon catheter placement for 12 hours PROCEDURE

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

Placement 12 hours

Eligibility Criteria

• Age: 18 Years - 46 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

tertiary center, women undergoing induction of labour

You may qualify if:

• destational age above or equal 37/0 weeks of gestation
• desired spontanous delivery
• Bishop-Score below or equal to 5
• cranial position
• single pregnancy

You may not qualify if:

• unable to consent
• pathological CTG according FIGO criteria

Sponsors & Collaborators

• Jena University Hospital: lead

Study Sites (1)

Jena University Hospital

Jena, Thuringia, 0774, Germany

Location

MeSH Terms

Interventions

Labor, Induced

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Ekkehard Schleußner, Prof. Dr.

  Jena University Hospital, Department of Obstetrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 24, 2023
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: January 12, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)