Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12611000198921
Ethics application status
Approved
Date submitted
15/02/2011
Date registered
21/02/2011
Date last updated
18/03/2014
Type of registration
Prospectively registered
Titles & IDs
Public title
Multicenter trial for induction of labor with the combination of misoprostol and mechanical ripening of the cervix
Query!
Scientific title
Randomized multicenter study of a combination of oral misoprostol (OM) and mechanical dilation of the cervix by double balloon device (COOK CRB [Cervical Ripening Balloon]) versus OM alone to improve efficacy in inducing labor.
Query!
Secondary ID [1]
253615
0
nil
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Efficacy of two different methods of labor induction at term - OM and Cook CRB versus OM alone.
261174
0
Query!
Condition category
Condition code
Reproductive Health and Childbirth
259329
259329
0
0
Query!
Childbirth and postnatal care
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Combination of OM and mechanical dilation with a double-balloon catheter for cervical ripening (COOK CRB) is used.
Each participating hospital uses its own misoprostol regime plus CRB for a maximum of 12 hours the first day.
e.g. the regime of the primary study unit:
First day: OM 50 microg with repeat doses 4 and 8 hours later if necessary plus CRB for a maximum of 12 hours
Second day: OM 100 microg with repeat doses 4 and 8 hours later if necessary
Third day: misoprostol 50 microg vaginally with repeat doses 4 and 8 hours later if necessary
Query!
Intervention code [1]
258048
0
Treatment: Drugs
Query!
Intervention code [2]
258066
0
Treatment: Devices
Query!
Intervention code [3]
258067
0
Treatment: Other
Query!
Comparator / control treatment
Only the misoprostol regime.
e.g. the regime of the primary study unit:
First day: OM 50 microg with repeat doses 4 and 8 hours
later if necessary
Second day: OM 100 microg with repeat doses 4 and 8 hours later if necessary
Third day: misoprostol 50 microg vaginally with repeat doses 4 and 8 hours later if necessary
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
262129
0
The rate of failure to induce labor, defined as no delivery within 48 hours.
Query!
Assessment method [1]
262129
0
Query!
Timepoint [1]
262129
0
Immediately after birth.
Query!
Secondary outcome [1]
273213
0
The time of induction of labor to birth.
Query!
Assessment method [1]
273213
0
Query!
Timepoint [1]
273213
0
Immediately after birth.
Query!
Eligibility
Key inclusion criteria
singleton pregnancy at term greater than 259 days of gestation, vertex presentation, indication for induction of labor, and an unfavorable cervix (Bishop score < 8)
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
45
Years
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
Premature Rupture of Membranes (PROM),
contraindication for labor induction with misoprostol (e.g. placenta previa, previous cesarean sections),
cases of structural or chromosomal malformation,
intrauterine fetal death.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Query!
Other design features
Query!
Phase
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
14/02/2011
Query!
Actual
1/05/2011
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
31/08/2012
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
250
Query!
Accrual to date
Query!
Final
Query!
Recruitment outside Australia
Country [1]
3205
0
Germany
Query!
State/province [1]
3205
0
Query!
Funding & Sponsors
Funding source category [1]
258507
0
University
Query!
Name [1]
258507
0
University Hospital Mannheim Department of Obstetrics and Gynecology
Query!
Address [1]
258507
0
Theodor-Kutzer-Ufer 1-3
68167 Mannheim
Query!
Country [1]
258507
0
Germany
Query!
Primary sponsor type
Individual
Query!
Name
Sven Kehl
Query!
Address
University Hospital Mannheim
Department of Obstetrics and Gynecology
Theodor-Kutzer-Ufer 1-3
68167 Mannheim
Australian
Query!
Country
Germany
Query!
Secondary sponsor category [1]
257644
0
None
Query!
Name [1]
257644
0
Query!
Address [1]
257644
0
Query!
Country [1]
257644
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Summary
Brief summary
Induction of labor is a common obstetric procedure that is being more widely used nowadays than ever before. Pharmacologic and mechanical methods are used to induce labor. As there are different modes of action, a reduced
induction-to-delivery time can be expected if the pharmacologic and mechanical methods are used simultaneously. The hypothesis is that a combination of pharmacological (oral misoprostol) and mechanical dilation
(CRB - a double balloon device) improve the efficacy of labor induction. In a primary study the combination showed to be beneficial. These results supposed to be checked in a multicenter trial with different misoprostol regimes.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
32221
0
Dr Sven Kehl
Query!
Address
32221
0
University Hospital Mannheim Department of Obstetrics and Gynecology Theodor-Kutzer-Ufer 1-3 68167 Mannheim
Query!
Country
32221
0
Germany
Query!
Phone
32221
0
+49-621-3832286
Query!
Fax
32221
0
Query!
Email
32221
0
[email protected]
Query!
Contact person for public queries
Name
15468
0
Dr Sven Kehl
Query!
Address
15468
0
University Hospital Mannheim
Department of Obstetrics and Gynecology
Theodor-Kutzer-Ufer 1-3
68167 Mannheim
Query!
Country
15468
0
Germany
Query!
Phone
15468
0
0049-621-3832286
Query!
Fax
15468
0
Query!
Email
15468
0
[email protected]
Query!
Contact person for scientific queries
Name
6396
0
Dr Sven Kehl
Query!
Address
6396
0
University Hospital Mannheim
Department of Obstetrics and Gynecology
Theodor-Kutzer-Ufer 1-3
68167 Mannheim
Query!
Country
6396
0
Germany
Query!
Phone
6396
0
0049-621-3832286
Query!
Fax
6396
0
Query!
Email
6396
0
[email protected]
Query!
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF