Induction of Labour With a Double Balloon Catheter

Labor, Induced Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05874024
• Other study ID #: DBK-Trial
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: January 12, 2023

Study information

• Verified date: April 2023
• Source: Jena University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: January 12, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 46 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor, Induced

Intervention

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.
• induction of labour with double balloon catheter placement for 12 hours
catheter placement for 12 hours in the evening at around 8 p.m.

Locations

Country	Name	City	State
Germany	Jena University Hospital	Jena	Thuringe

Sponsors (1)

Lead Sponsor	Collaborator
Jena University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	blood loss during delivery	maternal outcome blood loss during delivery in ml	at time of delivery
Secondary	number of participants with uterine rupture	maternal outcome uterine rupture	at time of delivery
Secondary	arterial umbilical pH	neonatal outcome arterial umbilical pH measured directly after delivery	at time of delivery
Secondary	arterial umbilical base excess	neonatal outcome arterial umbilical base excess measured directly after delivery	at time of delivery
Secondary	number of participants neonatal acidosis	neonatal outcome arterial umbilical pH < 7.1	at time of delivery
Secondary	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
Secondary	number of participants with pathological cardiotocography (CTG)	neonatal outcome pathological CTG (cardiotocography) at time of labour induction	at time of labour induction
Secondary	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