Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000542392
Ethics application status
Approved
Date submitted
24/09/2008
Date registered
27/10/2008
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The influence of antenatal education on second stage of labour
Scientific title
Can Antenatal Education Influence how women push in labour? A Pilot randomised Controlled Trial on Maternal Antenatal Teaching for Pushing in Second Stage of labour
Universal Trial Number (UTN)
Trial acronym
PUSH STUDY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
low risk first time pregnant women between 35-36 weeks gestation 3740 0
Structured antenatal education for pushing in second stage 3741 0
Condition category
Condition code
Reproductive Health and Childbirth 3916 3916 0 0
Antenatal care
Reproductive Health and Childbirth 3917 3917 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
structured antenatal education in the form of two, one to one teaching sessions one week apart. The teaching sessions involve visual and explanatory information and an internal vaginal examination.The session lasted about 15 minutes.
Intervention code [1] 3455 0
Other interventions
Comparator / control treatment
normal care (standard care of spontaneous pushing with contractions in labour and its impact on delivery outcome). That is women who did not receive antenatal educational sessions on how to push in second stage of labour
Control group
Active

Outcomes
Primary outcome [1] 4815 0
collecting data questionnaire on Length of active second stage of labour
Timepoint [1] 4815 0
During second stage of labour
Secondary outcome [1] 8129 0
data questionnaire on perineal trauma
Timepoint [1] 8129 0
During 3rd stage of labour

Eligibility
Key inclusion criteria
nulliparous women with a singleton cephalic presentation attending low risk antenatal care and planning a vaginal birth
Minimum age
18 Years
Maximum age
N/A
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Age below 18 years, cognitive impairment, high-risk pregnancy, contraindications to vaginal examination.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants were recruited through the antenatal clinics of the hospital through direct approach while the women waited for their antenatal appointment and through advertising in the clinic room. Eligible nulliparous women were those with a singleton cephalic presentation and planning a vaginal birth.'Once consented the women were randomly allocated, using envelope randomisation to intervention or control group' to this field.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The method of sequence generation used was a simple randomisation by using a randomisation table generated by a computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
No
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3919 0
Self funded/Unfunded
Name [1] 3919 0
Hala phipps
Country [1] 3919 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince alfred Hospital Women and Babies
Address
Royal Prince Alfred (RPA) Women and Babies, Building 89, Level5 east,
Royal Prince Alfred Hospital
Missenden Rd Camperdown, NSW, 2050
Country
Australia
Secondary sponsor category [1] 3516 0
None
Name [1] 3516 0
Address [1] 3516 0
Country [1] 3516 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5982 0
Sydney South west Area Health Service
Ethics committee address [1] 5982 0
Ethics committee country [1] 5982 0
Australia
Date submitted for ethics approval [1] 5982 0
Approval date [1] 5982 0
18/10/2004
Ethics approval number [1] 5982 0
X04-0158

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

Contacts
Principal investigator
Name 28971 0
Address 28971 0
Country 28971 0
Phone 28971 0
Fax 28971 0
Email 28971 0
Contact person for public queries
Name 12128 0
Hala Phipps
Address 12128 0
RPA Women and Babies, Building 89, Level5 east, Royal Prince Alfred
Missenden Rd camperdown 2050
Country 12128 0
Australia
Phone 12128 0
(02) 95156079
Fax 12128 0
(02) 95651595
Email 12128 0
[email protected]
Contact person for scientific queries
Name 3056 0
Hala Phipps
Address 3056 0
RPA Women and Babies, Building 89, Level5 east, Royal Prince Alfred
Missenden Rd camperdown 2050
Country 3056 0
Australia
Phone 3056 0
(02) 95156079
Fax 3056 0
(02) 95651595
Email 3056 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.