Comparison of patient satisfaction between two methods of induction of labour: use of a balloon catheter on an outpatient basis compared to an inpatient treatment with the medication "Propess".

Women's satisfaction with outpatient double-balloon catheter versus inpatient dinoprostone vaginal insert for induction of labour

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002978-39-AT

Enrollment

138

Registered

2019-04-11

Start date

2019-04-25

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

Induction of labour MedDRA version: 20.0 Level: PT Classification code 10052856 Term: Labour induction System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: PROPESS 10 mg vaginales Freisetzungssystem Product Name: PROPESS 10 mg vaginales Freisetzungssystem Pharmaceutical Form: Vaginal delivery system INN or Proposed INN: Dinoproston CAS Number

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Informed consent Age > 18 years Single pregnancy Fetal skull-position Gestational age 37+0 to 42+0 Timely development of the fetus Bishop score =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Known intolerance to the investigational products in use, or to products with a similar chemical structure Preterm rupture of membranes Known placentation disorder Previous conisation Previous cervix rupture Vaginal bleeding Fetal abnormalities Maternal disorders entailing an elevated risk for fetal distress or maternal complications Intrauterine death

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective is to evaluate patient satisfaction and experience between two different methods of labour induction; outpatient labour induction by means of a balloon catheter (COOK Cervical Ripening Balloon) compared to an inpatient treatment with Dinoproston (10mg – Vaginal- Insert , Propess®, Ferring Pharmaceuticals).;Secondary Objective: Evaluation and comparison of - prepartal inpatient stay in hours - Number of labour induction attempts until the development of contractions (cervix opening >= 3 cm) - rate of secondary Caesarean sections - neonatal outcome - rate of epidural anaesthesias - cost efficiency in both treatment arms;Primary end point(s): Patient satisfaction and experience of childbirth ;Timepoint(s) of evaluation of this end point: 1-5 days post-partum	—

Measure

Time frame

Main Objective: The main objective is to evaluate patient satisfaction and experience between two different methods of labour induction; outpatient labour induction by means of a balloon catheter (COOK Cervical Ripening Balloon) compared to an inpatient treatment with Dinoproston (10mg – Vaginal- Insert , Propess®, Ferring Pharmaceuticals).;Secondary Objective: Evaluation and comparison of - prepartal inpatient stay in hours - Number of labour induction attempts until the development of contractions (cervix opening >= 3 cm) - rate of secondary Caesarean sections - neonatal outcome - rate of epidural anaesthesias - cost efficiency in both treatment arms;Primary end point(s): Patient satisfaction and experience of childbirth ;Timepoint(s) of evaluation of this end point: 1-5 days post-partum

—

Secondary

Measure	Time frame
Secondary end point(s): -Prepartal inpatient stay in hours - Rate of Caesarean sections, vaginal births, instrumented vaginal deliveries - Neonatal/fetal outcome - Number of patients receiving oxytocin during childbirth - Rate of epidural anaesthesias - Cost efficiency in both treatment arms;Timepoint(s) of evaluation of this end point: 1-5 days post-partum	—

Countries

Austria

Contacts

Public ContactClinical Trials Information

Medizinische Universität Graz

ev.weiss@medunigraz.at004331680840

Outcome results

None listed

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