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Trial registered on ANZCTR


Registration number
ACTRN12611000126910
Ethics application status
Approved
Date submitted
2/02/2011
Date registered
4/02/2011
Date last updated
9/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Combination of Misoprostol and Mechanical Dilation for Induction of Labor
Scientific title
Randomized study of a combination of oral misoprostol (OM) and mechanical dilation of the cervix by a double balloon device (COOK CRB [Cervical Ripening Balloon]) versus OM alone to improve efficacy in inducing labor.
Secondary ID [1] 253525 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Effiaciacy of two different methods of labor induction at term 261076 0
Condition category
Condition code
Reproductive Health and Childbirth 259223 259223 0 0
Other reproductive health and childbirth disorders
Reproductive Health and Childbirth 259224 259224 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) was used.

First day: OM 50 microg with repeat doses 4 and 8 hours later if necessary plus CRB for a maximum of 24 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] 257954 0
Treatment: Other
Intervention code [2] 257962 0
Treatment: Drugs
Comparator / control treatment
Only OM was used.

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] 262058 0
The rate of failure to induce labor, defined as no delivery within 48 hours.
Timepoint [1] 262058 0
After birth.
Secondary outcome [1] 273068 0
The time of induction of labor to birth
Timepoint [1] 273068 0
After birth.

Eligibility
Key inclusion criteria
singleton pregnancy at term (= 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
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
cases of structural or chromosomal malformation and intrauterine fetal death, contraindication for labor induction with misoprostol (e.g. placenta previa, previous cesarean sections)

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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3165 0
Germany
State/province [1] 3165 0

Funding & Sponsors
Funding source category [1] 258416 0
University
Name [1] 258416 0
University Hospital Mannheim
Department of Obstetrics and Gynecology
Address [1] 258416 0
Theodor-Kutzer-Ufer 1-3
68167 Mannheim
Country [1] 258416 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
Country
Germany
Secondary sponsor category [1] 257567 0
None
Name [1] 257567 0
Address [1] 257567 0
Country [1] 257567 0

Ethics approval
Ethics application status
Approved

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32158 0
Address 32158 0
Country 32158 0
Phone 32158 0
Fax 32158 0
Email 32158 0
Contact person for public queries
Name 15405 0
Sven Kehl
Address 15405 0
University Hospital Mannheim
Department of Obstetrics and Gynecology

Theodor-Kutzer-Ufer 1-3
68167 Mannheim
Country 15405 0
Germany
Phone 15405 0
0049-621-3832286
Fax 15405 0
Email 15405 0
sven.kehl@umm.de
Contact person for scientific queries
Name 6333 0
Sven Kehl
Address 6333 0
University Hospital Mannheim
Department of Obstetrics and Gynecology

Theodor-Kutzer-Ufer 1-3
68167 Mannheim
Country 6333 0
Germany
Phone 6333 0
0049-621-3832286
Fax 6333 0
Email 6333 0
sven.kehl@umm.de

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary