Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000295347
Ethics application status
Approved
Date submitted
17/02/2017
Date registered
24/02/2017
Date last updated
5/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Antenatal Preparation for Childbirth. An Observational Study
Scientific title
An observational study to evaluate the types of communication and information provided by Childbirth educators during routine antenatal classes for expectant parents.
Secondary ID [1] 291212 0
None
Universal Trial Number (UTN)
U1111-1193-2285
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Antenatal preparation for Childbirth 302129 0
Condition category
Condition code
Reproductive Health and Childbirth 301743 301743 0 0
Antenatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Our observational study will video record Childbirth educators as they present their classes to 10 expectant couples. The visual recording will be of the Childbirth educators only. The audio will be of the childbirth educators and any incidental questions made by the expectant parents will also be recorded. The observations will occur in the education rooms, on site at the hospital. Antenatal classes are 2 hour sessions over a six week period (12hours total), or they can also run as two day sessions on the weekend - 6 hours duration each.
Intervention code [1] 297215 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301140 0
Identify types of communication and information provided by Childbirth educators, as assessed by study specific coding of audio visual recordings
Timepoint [1] 301140 0
12hours of childbirth classes administered over 6 weeks, in 2 hourly sessions
Secondary outcome [1] 331828 0
None
Timepoint [1] 331828 0
None

Eligibility
Key inclusion criteria
1. Childbirth Educators currently employed the Hospital.
2. Expectant parents
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Expectant parents less than 16 years of age
Expectant parents of non English speaking background
Expectant parents with an Intellectual impairment

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
There are three Childbirth educators at the Hospital.. Though statistically small, this pilot study will provide information that could be utilised for a future comparative investigation.
The video recordings of the Antenatal classes will be transcribed and analysed by two researchers. Descriptive statistics will be used for baseline data. The types of communications used when providing information will be based on previous studies of communication analysis in a clinical setting.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
29/11/2016
Date of last participant enrolment
Anticipated
2/05/2017
Actual
3/04/2017
Date of last data collection
Anticipated
Actual
17/04/2017
Sample size
Target
33
Accrual to date
Final
63
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7509 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 15333 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 295657 0
Self funded/Unfunded
Name [1] 295657 0
Country [1] 295657 0
Primary sponsor type
Hospital
Name
Nepean Hospital
Address
PO Box 63, Penrith, NSW 2751
Country
Australia
Secondary sponsor category [1] 294507 0
None
Name [1] 294507 0
Address [1] 294507 0
Country [1] 294507 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296974 0
Nepean Blue Mountains Local Health District HUMAN RESEARCH ETHICS OFFICE
Ethics committee address [1] 296974 0
Ethics committee country [1] 296974 0
Australia
Date submitted for ethics approval [1] 296974 0
16/09/2016
Approval date [1] 296974 0
27/09/2016
Ethics approval number [1] 296974 0
Study 16/45 - LNR/16/NEPEAN/74

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

Contacts
Principal investigator
Name 72594 0
Mrs Lisa Cutajar
Address 72594 0
Nepean Hospital,
Birth Unit
Po Box 63, Penrith, NSW 2570
Country 72594 0
Australia
Phone 72594 0
+61 437147387
Fax 72594 0
Email 72594 0
Lisa.Cutajar@health.nsw.gov.au
Contact person for public queries
Name 72595 0
Lisa Cutajar
Address 72595 0
Nepean Hospital
Birth Unit
PO Box 63, Penrith, 2570
NSW, Australia
Country 72595 0
Australia
Phone 72595 0
+61 437147387
Fax 72595 0
Email 72595 0
Lisa.Cutajar@health.nsw.gov.au
Contact person for scientific queries
Name 72596 0
Allan Cyna
Address 72596 0
Nepean Hospital
PO Box 63, Penrith, 2570
NSW, Australia
Country 72596 0
Australia
Phone 72596 0
+61 433707067
Fax 72596 0
Email 72596 0
allan.cyna@sa.gov.au

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.