Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000831280
Ethics application status
Approved
Date submitted
5/05/2018
Date registered
16/05/2018
Date last updated
6/05/2019
Date data sharing statement initially provided
6/05/2019
Date results information initially provided
6/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A novel determinant for the success of labor induction: Uterocervical Angle
Scientific title
A novel determinant for the success of labor induction: Uterocervical Angle, A prospective Observational Study
Secondary ID [1] 294806 0
none
Universal Trial Number (UTN)
U1111-1213-5056
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pregnancy 307726 0
Condition category
Condition code
Reproductive Health and Childbirth 306791 306791 0 0
Normal pregnancy
Reproductive Health and Childbirth 306792 306792 0 0
Antenatal care
Reproductive Health and Childbirth 306804 306804 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
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 anterior uterocervical angle by a protractor. the larger the anterior uterocervical angle is, the easier the parturient can give vaginal birth. 5 minute observation immediately prior to induction of labour, ultrasound performed upon admission to ward until induction of labour.
Intervention code [1] 301110 0
Early Detection / Screening
Intervention code [2] 301111 0
Diagnosis / Prognosis
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305771 0
determination of anterior uterocervical angle
Timepoint [1] 305771 0
before starting labor induction, after patient admission to ward, anterior uterocervical angle will be assessed by ultrasound.
Secondary outcome [1] 346495 0
cut-off limit of anterior uterocervical angle will be determined by measuring the anterior uterocervical angles with a protractor on the ultrasound images of the parturients who had a successful labor induction and give normal vaginal delivery.
Timepoint [1] 346495 0
before starting labor induction, after patient admission to ward, anterior uterocervical angle will be assessed by ultrasound.

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, multipar 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 the data. mean, median, frequencies and Pearson correlation test will be used for the data analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/06/2018
Actual
1/07/2018
Date of last participant enrolment
Anticipated
31/12/2018
Actual
20/10/2018
Date of last data collection
Anticipated
Actual
20/10/2018
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 10375 0
Turkey
State/province [1] 10375 0
kirsehir

Funding & Sponsors
Funding source category [1] 299403 0
Hospital
Name [1] 299403 0
Ahi Evran University Training and Research Hospital
Country [1] 299403 0
Turkey
Primary sponsor type
Individual
Name
fusun karbancioglu canturk
Address
Ahi Evran Univerisity Training and Research Hospital, Kervansaray Mah., 2019. Sok D:1, 40200 Kirsehir Merkez/Kirsehir
Country
Turkey
Secondary sponsor category [1] 298689 0
None
Name [1] 298689 0
none
Address [1] 298689 0
none
Country [1] 298689 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300306 0
Ahi Evran Üniversitesi Tip Fakültesi Klinik Arastirmalar Etik Kurulu
Ethics committee address [1] 300306 0
Ahi Evran Üniversitesi Tip Fakültesi Bagbasi yerleskesi 40100 Merkez/Kirsehir
Ethics committee country [1] 300306 0
Turkey
Date submitted for ethics approval [1] 300306 0
04/01/2018
Approval date [1] 300306 0
09/01/2018
Ethics approval number [1] 300306 0
2018-01/08

Summary
Brief summary
In this prospective observational study we aimed to determine the predictive power of anterior uterocervical angle on labor induction. secondary outcome of the study is to determine a cut off value for the anterior uterocervical angle that will guide the obstetrician to start labor induction .
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83230 0
Dr fusun karbancioglu canturk
Address 83230 0
Ahi Evran University Training and Research Hospital, Kervansaray Mah., 2019. Sok D:1, 40200 Kirsehir Merkez/Kirsehir
Country 83230 0
Turkey
Phone 83230 0
+905053574371
Fax 83230 0
+905053574371
Email 83230 0
[email protected]
Contact person for public queries
Name 83231 0
Dr fusun karbancioglu canturk
Address 83231 0
Ahi Evran University Training and Research Hospital, Kervansaray Mah., 2019. Sok D:1, 40200 Kirsehir Merkez/Kirsehir
Country 83231 0
Turkey
Phone 83231 0
+905053574371
Fax 83231 0
Email 83231 0
[email protected]
Contact person for scientific queries
Name 83232 0
Dr fusun karbancioglu canturk
Address 83232 0
Ahi Evran University Training and Research Hospital, Kervansaray Mah., 2019. Sok D:1, 40200 Kirsehir Merkez/Kirsehir
Country 83232 0
Turkey
Phone 83232 0
+905053574371
Fax 83232 0
Email 83232 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.