Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000537954
Ethics application status
Approved
Date submitted
10/05/2011
Date registered
25/05/2011
Date last updated
14/09/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of mechanical ripening of the cervix before induction of labor with misoprostol. A randomized multicenter trial.
Scientific title
Randomized multicenter study of mechanical ripening of the cervix by double balloon device (COOK CRB [Cervical Ripening Balloon]) before oral misoprostol (OM) versus OM alone to improve efficacy in inducing labor.
Secondary ID [1] 262146 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 - CRB before OM versus OM alone. 265825 0
Condition category
Condition code
Reproductive Health and Childbirth 265980 265980 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A double-balloon catheter for cervical ripening (COOK CRB) is used the first day (for a maximum of 12 hours) before inducing labor with misoprostol the second day.

Each participating hospital uses its own misoprostol regime.

e.g. the regime of the primary study unit:
First day: CRB (for a maximum of 12 hours)
Second day: OM 50 microg with repeat doses 4 and 8 hours later if necessary
Third day: OM 100 microg with repeat doses 4 and 8 hours later if necessary
Fourth day: misoprostol 100 microg vaginally with repeat doses 4 and 8 hours later if necessary
Intervention code [1] 264561 0
Treatment: Drugs
Intervention code [2] 264562 0
Treatment: Devices
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 100 microg vaginally with repeat doses 4 and 8 hours later if necessary
Control group
Active

Outcomes
Primary outcome [1] 266725 0
The time of induction of labor to birth.
Timepoint [1] 266725 0
Immediately after birth.
Secondary outcome [1] 276263 0
The rate of failure to induce labor, defined as no delivery within 48 hours.
Timepoint [1] 276263 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
15/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment outside Australia
Country [1] 3584 0
Germany
State/province [1] 3584 0

Funding & Sponsors
Funding source category [1] 265040 0
University
Name [1] 265040 0
University Medical Center Mannheim
Country [1] 265040 0
Germany
Primary sponsor type
Individual
Name
Sven Kehl
Address
University Medical Center
Department of Obstetrics and Gynecology
Theodor-Kutzer-Ufer 1-3
68167 Mannheim
Country
Germany
Secondary sponsor category [1] 264141 0
None
Name [1] 264141 0
Address [1] 264141 0
Country [1] 264141 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 32597 0
Address 32597 0
Country 32597 0
Phone 32597 0
Fax 32597 0
Email 32597 0
Contact person for public queries
Name 15844 0
Sven Kehl
Address 15844 0
University Medical Center
Department of Obstetrics and Gynecology
Theodor-Kutzer-Ufer 1-3
68167 Mannheim
Country 15844 0
Germany
Phone 15844 0
0049-621-3832286
Fax 15844 0
Email 15844 0
sven.kehl@umm.de
Contact person for scientific queries
Name 6772 0
Sven Kehl
Address 6772 0
University Medical Center
Department of Obstetrics and Gynecology
Theodor-Kutzer-Ufer 1-3
68167 Mannheim
Country 6772 0
Germany
Phone 6772 0
0049-621-3832286
Fax 6772 0
Email 6772 0
sven.kehl@umm.de

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.