Clinical Trials Register

Summary
EudraCT Number:	2017-002978-39
Sponsor's Protocol Code Number:	Ambulante_Geburtseinleitung
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2019-04-11
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Austria - BASG

A.2

EudraCT number

2017-002978-39

A.3

Full title of the trial

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

Zufriedenheit mit ambulanter Geburtseinleitung mittels
Ballonkatheter vs. stationärer Propesseinleitung
Offene prospektive monozentrische randomisierte Interventionsstudie

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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".

Vergleich der Patientinnenzufriedenheit bei zwei Methoden der Geburtseinleitung: ambulant mithilfe eines Ballonkatheters, verglichen mit der stationären Einleitung mittels des Medikaments "Propess®

A.3.2

Name or abbreviated title of the trial where available

Ambulante Geburtseinleitung

A.4.1

Sponsor's protocol code number

Ambulante_Geburtseinleitung

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Medizinische Universität Graz
B.1.3.4	Country	Austria
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Medizinische Universität Graz
B.4.2	Country	Austria
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Medizinische Universität Graz
B.5.2	Functional name of contact point	Clinical Trials Information
B.5.3	Address:
B.5.3.1	Street Address	Auenbruggerplatz 14
B.5.3.2	Town/ city	Graz
B.5.3.3	Post code	8036
B.5.3.4	Country	Austria
B.5.4	Telephone number	004331680840
B.5.6	E-mail	ev.weiss@medunigraz.at

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	PROPESS 10 mg vaginales Freisetzungssystem
D.2.1.1.2	Name of the Marketing Authorisation holder	FERRING Arzneimittel Ges.m.b.H
D.2.1.2	Country which granted the Marketing Authorisation	Austria
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	PROPESS 10 mg vaginales Freisetzungssystem
D.3.4	Pharmaceutical form	Vaginal delivery system
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Vaginal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Dinoproston
D.3.9.1	CAS number	0000363-24-6
D.3.9.3	Other descriptive name	DINOPROSTONE
D.3.9.4	EV Substance Code	SUB07195MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Induction of labour

Geburtseinleitung

E.1.1.1

Medical condition in easily understood language

Stimulation of childbirth

Künstliche Geburtsauslösung

E.1.1.2

Therapeutic area

Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10052856
E.1.2	Term	Labour induction
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

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).

Das Ziel der Studie ist die Evaluierung der Zufriedenheit und des
Geburtserlebens der Patientinnen im Vergleich zwischen ambulanter Geburtseinleitung mittels Doppel-Ballon-Katheter
(COOK Cervical Ripening Balloon®) und stationärer Geburtseinleitung mittels Dinoproston
10mg – Vaginal- Insert (Propess®, Ferring Pharmaceuticals).

E.2.2

Secondary objectives of the trial

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

Präpartale stationäre Aufenthaltsdauer in Stunden,
Anzahl der Einleitungsversuche bis zur Etablierung von
muttermundswirksamer Wehentätigkeit (Muttermundseröffnung ≥ 3
cm), sekundäre Sectiorate, neonatales Outcome,
Epiduralanästhesierate und Kosteneffektivität in beiden
Therapiearmen

E.2.3

Trial contains a sub-study

E.3

Principal 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 < 6
Amniotic sac intact
No previous uterine surgeries
No presence of contraindications for labour induction
No presence of amnion infection syndrome

-Schriftliche Einwilligung der teilnehmenden Person nach erfolgter Aufklärung
• Alter über 18 Jahre
• Einlingsschwangerschaft
• Fetale Schädellage
• Gestationsalter 37+0 bis 42+0
• Zeitgerecht entwickeltes Wachstum
• Unreife Zervix (Bishop Score <6)
• Intakte Fruchtblase
• Keine Uterusvoroperationen
• Keine Kontraindikationen für eine medikamentöse Einleitung
• Kein Vorliegen eines Amnioninfektionssyndroms

E.4

Principal 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

Anamnetisch bekannte Überempfindlichkeit gegenüber einem der
eingesetzten Medikamente oder deren Inhaltsstoffe oder
gegenüber Medikamenten mit ähnlicher chemischer Struktur
• Vorzeitiger Blasensprung
• Bekannte Plazentationsstörung
• Zustand nach Konisation
• Zustand nach Zervixriss
• Vaginale Blutung
• Fetale Anomalien
• Mütterliche Erkrankungen, die ein erhöhtes Risiko für fetalen
distress oder maternale Komplikationen im Geburtsverlauf mit
sich bringen
• Intrauteriner Fruchttod

E.5 End points

E.5.1

Primary end point(s)

Patient satisfaction and experience of childbirth

Zufriedenheit und Geburtserleben der Patientinnen

E.5.1.1

Timepoint(s) of evaluation of this end point

1-5 days post-partum

1-5 Tage nach der Geburt

E.5.2

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

Präpartale stationäre Aufenthaltsdauer in Stunden in beiden
Therapiearmen;
Anzahl der Patientinnen in Therapiearm 1 und Therapiearm 2, die per
vaginaler Geburt, per vaginal-operativer Geburt, per Kaiserschnitt
entbinden;
Fetale oder neonatale Morbidität oder Mortalität
Anzahl der Patientinnen in Therapiearm 1 und Therapiearm 2, die
eine Epiduralanästhesie erhalten;
Anzahl der Patientinnen in Therapiearm 1 und Therapiearm 2, die
subpartal Oxytocin erhalten;
Kostenanalyse in Therapiearm 1 und Therapiearm 2

E.5.2.1

Timepoint(s) of evaluation of this end point

1-5 days post-partum

1-5 Tage nach der Geburt

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Cost efficiency

Kosteneffizienz

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Ballonkatheter (Medizinprodukt mit CE-Kennzeichen)

Balloon catheter (medical device with CE-marking)

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

Letzter Besuch der letzten Patientin

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

138

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

Yes

F.3.3.4

Nursing women

Yes

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

138

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

According to local standards

Gemäß der Routineversorgung

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2019-04-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-05-03

P. End of Trial
P.	End of Trial Status	Ongoing

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