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Completed

NCT Number: NCT05874024

Induction of Labour With a Double Balloon Catheter

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).

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Key information

Conditions

Labor, Induced

Age range

18 year–46 year

Sex eligibility

Female

Study type

Observational

Primary location

Jena University Hospital

Jena, Thuringia, 0774, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. induction to delivery interval

    Time frame: 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

    the induction to delivery interval measured in minutes

Secondary outcomes

  1. number of participants with sequential drug induction of labour

    Time frame: assessd after double balloon catheter placement until time of birth, but not longer than 3 days

    the need for additional drugs for inductionof labour after the assigned placement time of the double balloon catheter

  2. prostaglandin to delivery interval

    Time frame: 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

    the prostaglandin to delivery interval measured in minutes

  3. mode of delivery

    Time frame: after induction of labour at time of delivery

    resulting mode of delivery after induction of labour expressed as spontaneous vaginal, vaginal operative or caesarean section

  4. blood loss during delivery

    Time frame: at time of delivery

    maternal outcome blood loss during delivery in ml

  5. number of participants with uterine rupture

    Time frame: at time of delivery

    maternal outcome uterine rupture

  6. arterial umbilical pH

    Time frame: at time of delivery

    neonatal outcome arterial umbilical pH measured directly after delivery

  7. arterial umbilical base excess

    Time frame: at time of delivery

    neonatal outcome arterial umbilical base excess measured directly after delivery

  8. number of participants neonatal acidosis

    Time frame: at time of delivery

    neonatal outcome arterial umbilical pH < 7.1

  9. apgar 5 min

    Time frame: 5 minutes after delivery

    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

  10. number of participants with pathological cardiotocography (CTG)

    Time frame: at time of labour induction

    neonatal outcome pathological CTG (cardiotocography) at time of labour induction

  11. number of participants with meconium-containing amniotic fluid

    Time frame: at time of delivery

    neonatal outcome meconium-containing amniotic fluid measured as visible green stained amniotic fluid at time of delivery

Sponsors and collaborators

Lead sponsor

Jena University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2023
First posted
May 24, 2023
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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