Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000990022
Ethics application status
Approved
Date submitted
12/11/2010
Date registered
16/11/2010
Date last updated
16/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Translabial Tridimensional Ultrasound Imaging of Uterine Cervical Dilatation in First Stage of Labor
Scientific title
Intrapartum Translabial Tridimensional Ultrasound Imaging of Uterine Cervical Dilatation in First Stage of Labor - A double Blind Study
Secondary ID [1] 253083 0
No secundary ID
Universal Trial Number (UTN)
U1111-1117-8667
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spontaneous labor in healthy, low risk, term, singelton parturients 258632 0
Condition category
Condition code
Reproductive Health and Childbirth 258773 258773 0 0
Normal pregnancy

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Intrapartum translabial 3D ultrasonographic imaging of uterine cervix using a Voluson 750 ultrasound system, GE Healthcare, Kretztechnik, Zipf, Austria, with a RAB2-5-RS 2- to 5-MHz convex 4-dimensional probe.
A wrapped ultrasound transducer is placed over patient's perineum, A volume acquisition (lasting around 30seconds) is repeated hourly until cervical dilatation of 5cm is reached
Intervention code [1] 257596 0
Diagnosis / Prognosis
Intervention code [2] 257602 0
Not applicable
Comparator / control treatment
Ultrasound imaging results were compared to digital vaginal examainations done by delivery room personel according delivery room standards of care
Control group
Active

Outcomes
Primary outcome [1] 259644 0
The study end point was the detection of transition from latent to active phase in first stage of labor defined as a documented change in cervical dilatation from 3cm to 5cm
Timepoint [1] 259644 0
the duration of entire labor
Secondary outcome [1] 266308 0
time to reach 3 and 5 cm cervical dilatation
Timepoint [1] 266308 0
the duration of entire labor

Eligibility
Key inclusion criteria
Included were all term (equal or greater than 37 weeks) low risk singleton parturients admitted to our delivery room with the diagnosis of labor as defined elsewhere who agreed to participate in the study and signed a detailed informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Excluded were preterm patients, multiple pregnancies and non vertex presentations. Participation was stopped in case of patient or delivery room team request; and in case of an obstetrical risk factor such as nonreassuring fetal heart rate tracing, vaginal bleeding, pre-eclampsia or the need for emergency intervention.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 3032 0
Israel
State/province [1] 3032 0
Tzeriffin

Funding & Sponsors
Funding source category [1] 258044 0
Self funded/Unfunded
Name [1] 258044 0
Ariel L ZImerman
Country [1] 258044 0
Israel
Primary sponsor type
Individual
Name
Ariel L ZImerman
Address
Obstetrics and Gynecological Division
Asaf Harofe Medical Center
Tzerifin 70300
Israel
Tel- 972-8-9779000
Fax-972-3-5343848
Country
Israel
Secondary sponsor category [1] 257232 0
Hospital
Name [1] 257232 0
Obstetrics and Gynecological Division Asaf Harofe Medical Center
Address [1] 257232 0
Obstetrics and Gynecological Division
Asaf Harofe Medical Center
Tzerifin 70300
Israel
Tel- 972-8-9779000
Fax-972-3-5343848
Country [1] 257232 0
Israel
Other collaborator category [1] 251651 0
Individual
Name [1] 251651 0
Proff. Rony Maymon
Address [1] 251651 0
Obstetrics and Gynecological Division
Asaf Harofe Medical Center
Tzerifin 70300
Israel
Tel- 972-8-9779000
Fax-972-3-5343848
Country [1] 251651 0
Israel

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260041 0
Asaf Harofe Helsinky Committee
Ethics committee address [1] 260041 0
Asaf Harofe Medical Center
Tzerifin 70300
Israel
Tel- 972-8-9779000
Fax-972-3-5343848
Ethics committee country [1] 260041 0
Israel
Date submitted for ethics approval [1] 260041 0
Approval date [1] 260041 0
21/05/2009
Ethics approval number [1] 260041 0
24/09*1

Summary
Brief summary
Sudy objective- To assess the use of non invasive intrapartum translabial 3D-US in the diagnosis of latent to active phase transition defined as an increase in cervical dilatation from 3cm to 5cm, and to compare it to digital vaginal examination.
Study methods- An observational prospective double blind clinical study. Hourly consecutive translabial 3D-US volumes are obtained in singleton term patients admitted to delivery room. Sonographers are blind to patient’s digital vaginal examination partogram. Patients and delivery room personnel are blind to sonographic results. Obtained volumes will be processed offline. Ultrasound maximal cervical diameter and vaginal digital examination will be compared.
Trial website
none
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 31900 0
Address 31900 0
Country 31900 0
Phone 31900 0
Fax 31900 0
Email 31900 0
Contact person for public queries
Name 15147 0
Ariel Zimerman
Address 15147 0
Obstetric and Gynecological Division
Asaf Harofe Medical Center
Tzeriffin 70300
Israel
Tel- 972-8-9779000
Fax- 972-3-5343848
Country 15147 0
Israel
Phone 15147 0
972-52-5616002
Fax 15147 0
972-3-5343848
Email 15147 0
[email protected]
Contact person for scientific queries
Name 6075 0
Ariel Zimerman
Address 6075 0
Obstetric and Gynecological Division
Asaf Harofe Medical Center
Tzeriffin 70300
Israel
Tel- 972-8-9779000
Fax- 972-3-5343848
Country 6075 0
Israel
Phone 6075 0
972-52-5616002
Fax 6075 0
972-3-5343848
Email 6075 0
[email protected]

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.