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Trial registered on ANZCTR


Registration number
ACTRN12612000228886
Ethics application status
Approved
Date submitted
21/02/2012
Date registered
23/02/2012
Date last updated
14/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does mechanical dilatation of the cervix at non-labour caesarean section reduce postoperative morbidity?
Scientific title
Reduction of postoperative morbidity by mechanical dilatation of the cervix at non-labour caesarean? A randomized controlled trial
Secondary ID [1] 279995 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Efficacy of mechanical dilatation of the cervix at non-labour caesarean section 285904 0
Condition category
Condition code
Reproductive Health and Childbirth 286096 286096 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mechanical dilatation of the cervix using a surgical instrument (dilatator) at non-labour caesarean section.

Description: After removal of the placenta the cervix will be dilated by a hegar uterine dilator (size 15). Duration circa one second.
Intervention code [1] 284322 0
Treatment: Devices
Comparator / control treatment
No dilatation.
Control group
Active

Outcomes
Primary outcome [1] 286571 0
Postpartum Hemorrhage (blood loss more than 1000 ml) - assessed by clinical assessment
Timepoint [1] 286571 0
24 hours after childbirth
Secondary outcome [1] 296192 0
Blood transfusion needed - e.g. hemoblobin level below 7 g/dl
Timepoint [1] 296192 0
Within 6 weeks after childbirth.
Secondary outcome [2] 296193 0
Hemoglobin - indicates blood loss (assessed by blood analysis)
Timepoint [2] 296193 0
Day 1 after childbirth
Secondary outcome [3] 296194 0
Secondary postpartum hemorrhage - assessed by clinical assessment
Timepoint [3] 296194 0
Within 6 weeks after childbirth.
Secondary outcome [4] 296195 0
Infection - assessed by clinical assessment (temperatur greater than 38,5 degrees C, blood tests - e.g. CRP)
Timepoint [4] 296195 0
Within 6 weeks after childbirth.
Secondary outcome [5] 296196 0
Cervical trauma - assessed by clinical assessment
Timepoint [5] 296196 0
After childbirth
Secondary outcome [6] 296197 0
Subinvolution - assessed by clinical assessment
Timepoint [6] 296197 0
Day 5 after childbirth.
Secondary outcome [7] 296198 0
Time of surgery - assessed by medical records data
Timepoint [7] 296198 0
After surgery.

Eligibility
Key inclusion criteria
Greater than 23+6 weeks of gestation, non-labour caesarean section
Minimum age
No limit
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Sign of infection, running antibiotic therapy, opening of the cervix

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] 4160 0
Germany
State/province [1] 4160 0

Funding & Sponsors
Funding source category [1] 284754 0
University
Name [1] 284754 0
University Medical Center Mannheim
Address [1] 284754 0
Theodor-Kutzer-Ufer 1-3
68167 Mannheim
Country [1] 284754 0
Germany
Primary sponsor type
Individual
Name
Sven Kehl
Address
University Medical Center Mannheim
Department of Obstetrics and Gynecology
Theodor-Kutzer-Ufer 1-3
68167 Mannheim
Country
Germany
Secondary sponsor category [1] 283646 0
None
Name [1] 283646 0
Address [1] 283646 0
Country [1] 283646 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
In clinical routine some obstetricians routinely dilate the cervix from above during non-labour caesarean because they believe that the cervix of women without labour pain is undilated and may cause obstruction of blood or lochia drainage. However, this procedure may result in contamination by vaginal micro-organisms during dilatation, and increase the risk of infection or cervical trauma.

An actual cochrane analysis (http://www.ncbi.nlm.nih.gov/pubmed?term=Mechanical%20dilatation%20of%20the%20cervix%20at%20non-labour%20caesarean%20section%20for%20reducing%20postoperative%20morbidity) stated that there is insufficient evidence of mechanical dilatation of the cervix at non-labour caesarean section for reducing postoperative morbidity. The autors concluded that further randomised controlled trials with adequate methodological quality comparing intraoperative cervical dilatation during non-labour caesarean section versus no mechanical dilatation for reducing postoperative morbidity are needed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33814 0
Dr Sven Kehl
Address 33814 0
University Medical Center Department of Obstetrics and Gynecology Theodor-Kutzer-Ufer 1-3 68167 Mannheim
Country 33814 0
Germany
Phone 33814 0
+49-621-3832286
Fax 33814 0
Email 33814 0
sven.kehl@gmail.com
Contact person for public queries
Name 17061 0
Dr Sven Kehl
Address 17061 0
University Medical Center
Department of Obstetrics and Gynecology
Theodor-Kutzer-Ufer 1-3
68167 Mannheim
Country 17061 0
Germany
Phone 17061 0
+49-621-3832286
Fax 17061 0
Email 17061 0
sven.kehl@gmail.com
Contact person for scientific queries
Name 7989 0
Dr Sven Kehl
Address 7989 0
University Medical Center
Department of Obstetrics and Gynecology
Theodor-Kutzer-Ufer 1-3
68167 Mannheim
Country 7989 0
Germany
Phone 7989 0
+49-621-3832286
Fax 7989 0
Email 7989 0
sven.kehl@gmail.com

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