Trial Review

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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
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.
Secondary ID [1] 253615 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

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
Condition category
Condition code
Reproductive Health and Childbirth 259329 259329 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 258048 0
Treatment: Drugs
Intervention code [2] 258066 0
Treatment: Devices
Intervention code [3] 258067 0
Treatment: Other
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
Control group
Active

Outcomes
Primary outcome [1] 262129 0
The rate of failure to induce labor, defined as no delivery within 48 hours.
Timepoint [1] 262129 0
Immediately after birth.
Secondary outcome [1] 273213 0
The time of induction of labor to birth.
Timepoint [1] 273213 0
Immediately after birth.

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)
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/02/2011
Actual
1/05/2011
Date of last participant enrolment
Anticipated
Actual
31/08/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment outside Australia
Country [1] 3205 0
Germany
State/province [1] 3205 0

Funding & Sponsors
Funding source category [1] 258507 0
University
Name [1] 258507 0
University Hospital Mannheim Department of Obstetrics and Gynecology
Country [1] 258507 0
Germany
Primary sponsor type
Individual
Name
Sven Kehl
Address
University Hospital Mannheim
Department of Obstetrics and Gynecology

Theodor-Kutzer-Ufer 1-3
68167 Mannheim
Australian
Country
Germany
Secondary sponsor category [1] 257644 0
None
Name [1] 257644 0
Address [1] 257644 0
Country [1] 257644 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32221 0
Dr Sven Kehl
Address 32221 0
University Hospital Mannheim Department of Obstetrics and Gynecology Theodor-Kutzer-Ufer 1-3 68167 Mannheim
Country 32221 0
Germany
Phone 32221 0
+49-621-3832286
Fax 32221 0
Email 32221 0
sven.kehl@gmail.com
Contact person for public queries
Name 15468 0
Sven Kehl
Address 15468 0
University Hospital Mannheim
Department of Obstetrics and Gynecology

Theodor-Kutzer-Ufer 1-3
68167 Mannheim
Country 15468 0
Germany
Phone 15468 0
0049-621-3832286
Fax 15468 0
Email 15468 0
sven.kehl@gmail.com
Contact person for scientific queries
Name 6396 0
Sven Kehl
Address 6396 0
University Hospital Mannheim
Department of Obstetrics and Gynecology

Theodor-Kutzer-Ufer 1-3
68167 Mannheim
Country 6396 0
Germany
Phone 6396 0
0049-621-3832286
Fax 6396 0
Email 6396 0
sven.kehl@gmail.com

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.