Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000936224
Ethics application status
Approved
Date submitted
28/05/2018
Date registered
4/06/2018
Date last updated
6/05/2019
Date data sharing statement initially provided
6/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of cervical length and uterocervical angle measurements on the decision of labour induction : A prospective observational study.
Scientific title
The effect of cervical length and uterocervical angle measurements on the decision of labour induction
Secondary ID [1] 295009 0
none
Universal Trial Number (UTN)
U1111-1214-7458
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pregnancy 308028 0
Condition category
Condition code
Reproductive Health and Childbirth 307064 307064 0 0
Normal pregnancy
Reproductive Health and Childbirth 307065 307065 0 0
Antenatal care
Reproductive Health and Childbirth 307066 307066 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cervical length ( measured in cm from the usg image which is defined as the distance between internal cervical os and external cervical os) and anterior uterocervical angle ( the angle between the anterior border of uterus and cervical canal) will be visualized by transvaginal ultrasound and the printout of the screen will be used to measure the cervical length by a tape measure and uterocervical angle will be measured by a protractor 5 minute observation immediately prior to induction of labor, ultrasound performed upon admission to ward untill induction of labor.
Intervention code [1] 301343 0
Early Detection / Screening
Intervention code [2] 301344 0
Diagnosis / Prognosis
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306038 0
cervical length
Timepoint [1] 306038 0
visualized by transvaginal ultrasound and the printout of the screen will be used to measure the cervical length by a tape measure (measured in cm from the usg image which is defined as the distance between internal cervical os and external cervical os) 5 minute observation immediately prior to induction of labor, ultrasound performed upon admission to ward untill induction of labor.
Primary outcome [2] 306039 0
anterior uterocervical angle
Timepoint [2] 306039 0
anterior uterocervical angle ( the angle between the anterior border of uterus and cervical canal) will be visualized by transvaginal ultrasound and the printout of the screen will be used to measure the uterocervical angle by a protractor 5 minute observation immediately prior to induction of labor, ultrasound performed upon admission to ward untill induction of labor.
Secondary outcome [1] 347398 0
decision of labour induction, assessed by the data gained from ultrasound image of cervical length and anterior uterocervical angle and direct observation of obstetrician
Timepoint [1] 347398 0
following the admission of the patient to the ward just before labour induction

Eligibility
Key inclusion criteria
singleton pregnancies between 37-42 weeks of gestation who is not in active labor with vertex presentation
Minimum age
15 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
parturients in active labor, multiparous pregnancies, complicated pregnancies, presentation anomalies, any known fetal anomalies.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
IBM SPSS package program will be used for the analysis of data. Mean, median, frequencies, ANOVA, chi square test and Pearson's Correlation test will be used for the analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2018
Actual
2/07/2018
Date of last participant enrolment
Anticipated
30/12/2018
Actual
24/10/2018
Date of last data collection
Anticipated
30/12/2018
Actual
24/10/2018
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 10509 0
Turkey
State/province [1] 10509 0
kirsehir

Funding & Sponsors
Funding source category [1] 299593 0
Hospital
Name [1] 299593 0
Ahi Evran University Training and Research Hospital
Country [1] 299593 0
Turkey
Primary sponsor type
Individual
Name
fusun karbancioglu canturk
Address
Ahi Evran University Training and Research Hospital Kervansaray Mah 2019. sok D:1 40200 Merkez Kirsehir Turkey
Country
Turkey
Secondary sponsor category [1] 298910 0
None
Name [1] 298910 0
Address [1] 298910 0
Country [1] 298910 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300493 0
Ahi Evran Üniversitesi Tip Fakültesi Klinik Arastirmalar Etik Kurulu
Ethics committee address [1] 300493 0
Ethics committee country [1] 300493 0
Turkey
Date submitted for ethics approval [1] 300493 0
04/01/2018
Approval date [1] 300493 0
09/01/2018
Ethics approval number [1] 300493 0
2018-01/07

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

Contacts
Principal investigator
Name 83838 0
Dr fusun karbancioglu canturk
Address 83838 0
Ahi Evran University Training and Research Hospital, Kervansaray Mah. 2019.sok d:1 40200 merkez kirsehir
Country 83838 0
Turkey
Phone 83838 0
+905053574371
Fax 83838 0
Email 83838 0
[email protected]
Contact person for public queries
Name 83839 0
fusun karbancioglu canturk
Address 83839 0
Ahi Evran University Training and Research Hospital, Kervansaray Mah. 2019.sok d:1 40200 merkez kirsehir
Country 83839 0
Turkey
Phone 83839 0
+905053574371
Fax 83839 0
Email 83839 0
[email protected]
Contact person for scientific queries
Name 83840 0
fusun karbancioglu canturk
Address 83840 0
Ahi Evran University Training and Research Hospital, Kervansaray Mah. 2019.sok d:1 40200 merkez kirsehir
Country 83840 0
Turkey
Phone 83840 0
+905053574371
Fax 83840 0
Email 83840 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.