Success rate of initiation of birth process at term by inserting a balloon into the cervix compared by inserting a vaginal delivery system (dinoprostone).

Efficacy of induction of labor on term using a double balloon catheter compared to Dinoprostone vaginal-insert – a multicenter randomized controlled trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004880-36-AT

Enrollment

253

Registered

2013-05-29

Start date

2013-06-17

Completion date

Unknown

Last updated

2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational age between the 37th and 42th gestation week

Interventions

Trade Name: Propess Pharmaceutical Form: Vaginal delivery system INN or Proposed INN: Dinoproston Other descriptive name: DINOPROSTONE Concentration unit: mg milligram(s) Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Maternal age > 18 years Alter Signed Informed Consent Singleton Pregnancy Cephalic presentation no preterm rupture of membranes gestational age: 37+0 – 42+0 weeks unfavourable cervix (Bishop-Score = 6) absence of contra-indications for pharmaceutical induction of labor no clinical signs of infection or inflammation (temperature =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Fetal malformation Presence of contra-indications for pharmaceutical induction of labor Placentation disorders History of uterine surgery with opening of the uterine cavum incl. ceasaren section. preterm rupture of membranes multiple gestations gestational age < 37+0 weeks History of surgery for cervical tear

Design outcomes

Primary

Measure	Time frame
Main Objective: Time between first intervention (Balloon Application or Propess administration) and birth in treatment arm 1 and 2. ;Secondary Objective: 1.Time interval from first treatment (balloon application/first Propess application) to cervical dilating progress of labor;2.Time interval from first treatment (balloon application/first Propess application) to continous labor (>6contractions/hour);3.Percentage of patients in arm 1 and 2,who achieve vaginal or vaginal-operative delivery;4.Percentage of patients in arm 1 and 2,who underwent caesarean section after failed induction of labor.Failed induction of labor is defined as not-achieving vaginal delivery after balloon application+2xPropess application in arm 1 and 3xPropess application in arm 2;5.Patient satisfaction with treatment in arm 1 and 2;6.Neonatal Parameters:Fetal and/or neonatal morbidity and/or mortality (pH-levels,Base Exsess,APGAR,fetal birth weight,admission to ICU,days at ICU);7.Maternal Parameters:Signs of infection or inflammation (temp>38,5°, WBC>25%+CRP-elevation >25%compared to hospital admission), cervical tear,vaginal tear, episoiotomy), epidural anaesthesia;Primary end point(s): 1. Due to the use of a cook balloon catheter an effective birth cervix progress (defined as Bishop score = 9 and / or cervical dilatation = 3 cm) patients with unripe cervix (Bishop score = 6) can be performed. 2. The time intervall between the first intervention and the birth is shorter for inducing labor with balloon application than first propess application. 3. The proportion of patients who receive after failed induction of labor a caesarean is lower than balloon induction;Timepoint(s) of evaluation of this end point: Day 0, Day 1, Day 2, Day 3, postpartal: within 48 hours	—

Measure

Time frame

Main Objective: Time between first intervention (Balloon Application or Propess administration) and birth in treatment arm 1 and 2. ;Secondary Objective: 1.Time interval from first treatment (balloon application/first Propess application) to cervical dilating progress of labor;2.Time interval from first treatment (balloon application/first Propess application) to continous labor (>6contractions/hour);3.Percentage of patients in arm 1 and 2,who achieve vaginal or vaginal-operative delivery;4.Percentage of patients in arm 1 and 2,who underwent caesarean section after failed induction of labor.Failed induction of labor is defined as not-achieving vaginal delivery after balloon application+2xPropess application in arm 1 and 3xPropess application in arm 2;5.Patient satisfaction with treatment in arm 1 and 2;6.Neonatal Parameters:Fetal and/or neonatal morbidity and/or mortality (pH-levels,Base Exsess,APGAR,fetal birth weight,admission to ICU,days at ICU);7.Maternal Parameters:Signs of infection or inflammation (temp>38,5°, WBC>25%+CRP-elevation >25%compared to hospital admission), cervical tear,vaginal tear, episoiotomy), epidural anaesthesia;Primary end point(s): 1. Due to the use of a cook balloon catheter an effective birth cervix progress (defined as Bishop score = 9 and / or cervical dilatation = 3 cm) patients with unripe cervix (Bishop score = 6) can be performed. 2. The time intervall between the first intervention and the birth is shorter for inducing labor with balloon application than first propess application. 3. The proportion of patients who receive after failed induction of labor a caesarean is lower than balloon induction;Timepoint(s) of evaluation of this end point: Day 0, Day 1, Day 2, Day 3, postpartal: within 48 hours

—

Secondary

Measure	Time frame
Secondary end point(s): The patients are more satisfied with the implementation of a balloon than propess-induction.;Timepoint(s) of evaluation of this end point: postpartal: within 48 hours	—

Countries

Austria

Contacts

Public ContactObstetrics & Gynecology Department

Medical University of Graz,Devision of Gynecology

obgyn@medunigraz.at4331638512150

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026