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

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).

Study Overview

• Status: Completed
• Conditions: Labor, Induced
• Intervention / Treatment: Procedure: induction of labour with double balloon catheter placement for 6 hours; Procedure: induction of labour with double balloon catheter placement for 12 hours

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.

• Study Type: Observational
• Enrollment (Actual): 248

Contacts and Locations

Study Locations

• Germany
  • Thuringe
    • Jena, Thuringe, Germany, 0774
      • Jena University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

tertiary center, women undergoing induction of labour

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Placement 6 hours; double balloon catheter placement for 6 hours	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.
Placement 12 hours; double balloon catheter placement for 12 hours	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of participants with sequential drug induction of labour	the need for additional drugs for inductionof labour after the assigned placement time of the double balloon catheter	assessd after double balloon catheter placement until time of birth, but not longer than 3 days
prostaglandin to delivery interval	the prostaglandin to delivery interval measured in minutes	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	resulting mode of delivery after induction of labour expressed as spontaneous vaginal, vaginal operative or caesarean section	after induction of labour at time of delivery
blood loss during delivery	maternal outcome blood loss during delivery in ml	at time of delivery
number of participants with uterine rupture	maternal outcome uterine rupture	at time of delivery
arterial umbilical pH	neonatal outcome arterial umbilical pH measured directly after delivery	at time of delivery
arterial umbilical base excess	neonatal outcome arterial umbilical base excess measured directly after delivery	at time of delivery
number of participants neonatal acidosis	neonatal outcome arterial umbilical pH < 7.1	at time of delivery
apgar 5 min	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	5 minutes after delivery
number of participants with pathological cardiotocography (CTG)	neonatal outcome pathological CTG (cardiotocography) at time of labour induction	at time of labour induction
number of participants with meconium-containing amniotic fluid	neonatal outcome meconium-containing amniotic fluid measured as visible green stained amniotic fluid at time of delivery	at time of delivery

Collaborators and Investigators

• Sponsor: Jena University Hospital
• Investigators: Principal Investigator: Ekkehard Schleußner, Prof. Dr., Jena University Hospital, Department of Obstetrics

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): January 12, 2023

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: May 22, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: cervical ripening; double balloon catheter; time to delivery
• Other Study ID Numbers: DBK-Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No