Clinical Trials Register

Summary
EudraCT Number:	2011-000026-30
Sponsor's Protocol Code Number:	ABR35278
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-10-07
Trial results	View 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

Netherlands - Competent Authority

A.2

EudraCT number

2011-000026-30

A.3

Full title of the trial

Induction of Labour with a Foley catheter or oral Misoprostol at Term

A.3.1

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

comparison of two different methods (Foley cetheter or oral misoprostol) for labour induction

A.3.2

Name or abbreviated title of the trial where available

PROBAAT-II

A.4.1

Sponsor's protocol code number

ABR35278

A.5.4

Other Identifiers

Name:

The Netherlands Trial Register

Number:

NTR3466

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	Academic medical centre
B.1.3.4	Country	Netherlands
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	Fonds Nuts Ohra
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Academic medical centre
B.5.2	Functional name of contact point	Verloskundig consortium
B.5.3	Address:
B.5.3.1	Street Address	Meibergdreef 9
B.5.3.2	Town/ city	Amsterdam
B.5.3.3	Post code	1105 AZ
B.5.3.4	Country	Netherlands
B.5.6	E-mail	b.w.mol@amc.uva.nl

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
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	Cytotec
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	misoprostol
D.3.9.1	CAS number	59122-46-2
D.3.9.3	Other descriptive name	MISOPROSTOL
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
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 at term

E.1.1.1

Medical condition in easily understood language

Induction of labour at term

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	16.0
E.1.2	Level	LLT
E.1.2	Classification code	10023540
E.1.2	Term	Labor induced
E.1.2	System Organ Class	100000004868

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To assess in term pregnant women with an unfavourable cervix (Bischop score <6) the effectiveness of induction of labor with a transcervical Foley catheter or oral misoprostol

E.2.2

Secondary objectives of the trial

To study the safety, costs and patients preferences for both methods

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Term pregnancy (≥37 weeks of pregnancy)
Scheduled for induction of labour
Vital singleton pregnancy
Intact membranes
Unfavourable cervix (Bishop score < 6)
Cephalic presentation

E.4

Principal exclusion criteria

Previous caesarean section
Placenta praevia
Hypersensitivity for one of the products used for induction
Age <18 years
Lethal congenital anomalies

E.5 End points

E.5.1

Primary end point(s)

The main endpoint will be a composite outcome of neonatal asphyxia (defined as a neonatal
pH≤7.10 and/or 5 minute Apgar<7) and post partum haemorrhage (defined as an estimated
blood loss of ≥1000 cc ascertained over 24h post partum)

E.5.1.1

Timepoint(s) of evaluation of this end point

After inclusions, estimated time will be july 2014

E.5.2

Secondary end point(s)

Mode of delivery (Caesarean section, vaginal instrumental delivery) and the reason
for instrumental delivery, i.e. suspected fetal distress and arrest of labor.
• Induction to delivery time
• Use of analgesics
• Oxytocin use
• Maternal morbidity
o Maternal post partum blood transfusion
o Hyperstimulation (defined as more than five contractions in ten minutes over a
minimal period of two times ten minutes with FHR changes)
o Uterine hypertonus (defined as a contraction lasting more than three minutes
with FHR changes)
o Uterine rupture (separation of the uterine wall)
o Maternal infection
 Fever (defined as a temperature ≥ 37.8°C) during labor or fetal
tachycardia and start of antibiotics
 Fever (defend as a temperature ≥ 37.8 °C) within one week
post partum and start of antibiotics
 Fetal tachycardia (a sustained fetal heart rate above 160 beats
per minute)
 Start of intravenous broad-spectrum antibiotics
 Endo(myo)etritis or urinary tract infection within one week post
partum (proven positive vaginal discharge/urine culture)
• Neonatal morbidity
o Meconium –stained liquor
o Apgar scores < 7 at 1 and 5 minutes
o Admissions to the neonatal ward/NICU
 Due to suspected infection
 Due to infection proven by positive culture
 Other reason admission to medium care
 Other reason admission to intensive care
• Women’s preference; post partum questionnaire developed for this study, based on
well established and validated questionnaire by K. Wijma et al. This is a
questionnaire which was developed to assess how women experienced their labor
(22).
• Costs

E.5.2.1

Timepoint(s) of evaluation of this end point

After inclusions, estimated time will be july 2014

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

E.6.4

Safety

Yes

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

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)

Yes

E.7.4

Therapeutic use (Phase IV)

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

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

Yes

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

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial 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:

1860

F.1.3

Elderly (>=65 years)

F.1.3.1

Number of subjects for this age range:

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

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

1760

F.4.2

For a multinational trial

F.4.2.1

In the EEA

1860

F.4.2.2

In the whole clinical trial

1860

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)

None

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	Verloskundig consortium
G.4.3.4	Network Country	Netherlands

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-05-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-05-21

P. End of Trial
P.	End of Trial Status	Completed

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