Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000098033
Ethics application status
Approved
Date submitted
30/11/2009
Date registered
1/02/2010
Date last updated
1/02/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
What is the effect of a midwife-led counselling intervention on mental health outcomes of distressed postpartum women?
Scientific title
Do women who have experienced a traumatic birth and are provided with a midwife led counselling intervention compared with parenting support experience lower levels of postnatal distress?
Secondary ID [1] 1290 0
None
Universal Trial Number (UTN)
U1111-1112-5331
Trial acronym
PRIME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Trauma in perinatal period 252210 0
Depression in perinatal period 252211 0
Anxiety in perinatal period 252212 0
Stress in perinatal period 252214 0
Condition category
Condition code
Mental Health 239946 239946 0 0
Depression
Mental Health 239947 239947 0 0
Anxiety
Mental Health 252400 252400 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women experiencing a distressing birth were randomised to counselling or parenting support. The counselling or parenting support was delivered face to face within the first week after the birth and over the telephone at 4- 6 weeks.

Women in the study will also be offered a qualitative interview to explore their experiences upon completion of the study intervention, and this is a separate component of this particular trial.
Intervention code [1] 241226 0
Prevention
Intervention code [2] 241557 0
Treatment: Other
Comparator / control treatment
Parenting support (active control) and usual care (matched control). Usual care involved completion of a questionnaire at the point that the midwife visited after the birth and at 6 weeks postpartum. All groups received the usual follow-up as provided by the hospital.
Control group
Active

Outcomes
Primary outcome [1] 240754 0
Trauma and depression will be measured through completion of questionnaires:
Depression Anxiety Stress Scale (DASS -21) at Q1 to Q5;
Edinburgh Postnatal Depression Scale (EPDS) at Q1 to Q5;
Post traumatic symptom scale (PSS) at Q1, Q3 to Q5
Timepoint [1] 240754 0
Participants complete questionnaires at 5 time points:
Q1 antenatally (i.e. 36 weeks in last trimester);
Q2 within the first week after the birth;
Q3 at 4-6 weeks after the birth;
Q4 at 6 months after the birth;
Q5 at 12 months after the birth
Secondary outcome [1] 257421 0
Anxiety and stress will be measured through completion of a questionnaire:
Depression Anxiety Stress Scale (DASS -21) at Q1 to Q5
Timepoint [1] 257421 0
Participants complete questionnaires at 5 time points;
Q1 antenatally (i.e. 36 weeks in last trimester),
Q2 within the first week after the birth,
Q3 at 4-6 weeks after the birth
Q4 at 6 months after the birth
Q5 at 12 months after the birth

Eligibility
Key inclusion criteria
Pregnant women expecting a live baby and not in psychological/psychiatric treatment. Adequate language skills (English).
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
In current psychological/psychiatric treatment. Not able to communicate well in English.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Women are recruited from antenatal clinics during the third trimester of pregnancy. Women are provided with information sheets and given consent forms for participation. Women consenting to participation are contacted after the birth of their child. After the birth women are randomised to either intervention or control groups if they indicate "distress" on the measures. Group allocation concealed in tamper proof sequenced envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator used to produce order of intervention/control.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
30/09/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2070 0
4217 Gold Coast
Recruitment postcode(s) [2] 2347 0
6008 Subiaco

Funding & Sponsors
Funding source category [1] 243607 0
Government body
Name [1] 243607 0
National Health and Medical Research Council
Country [1] 243607 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Logan campus Griffith University
University Drive
MEADOWBROOK QLD 4131
Country
Australia
Secondary sponsor category [1] 237056 0
University
Name [1] 237056 0
Curtin University
Address [1] 237056 0
Kent Street,
Bentley, WA 6102
GPO BOX U1987
Country [1] 237056 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243733 0
Human Research Ethic Committee Griffith University
Ethics committee address [1] 243733 0
Ethics committee country [1] 243733 0
Australia
Date submitted for ethics approval [1] 243733 0
Approval date [1] 243733 0
21/02/2008
Ethics approval number [1] 243733 0
NRS/03/08/HREC

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

Contacts
Principal investigator
Name 30155 0
Address 30155 0
Country 30155 0
Phone 30155 0
Fax 30155 0
Email 30155 0
Contact person for public queries
Name 13402 0
Assoc Professor Jenny Gamble
Address 13402 0
School of Nursing & Midwifery,
Griffith Health
Griffith University
Logan Campus
University Drive, Meadowbrook
Queensland 4131
Country 13402 0
Australia
Phone 13402 0
+61 7 3382 1083
Fax 13402 0
+61 7 3735 3388
Email 13402 0
[email protected]
Contact person for scientific queries
Name 4330 0
Assoc Professor Jenny Gamble
Address 4330 0
School of Nursing & Midwifery,
Griffith Health
Griffith University
Logan Campus
University Drive, Meadowbrook
Queensland 4131
Country 4330 0
Australia
Phone 4330 0
+61 7 3382 1083
Fax 4330 0
+61 7 3735 3388
Email 4330 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
SourceTitleYear of PublicationDOI
Dimensions AIPRIME: impact of previous mental health problems on health-related quality of life in women with childbirth trauma2013https://doi.org/10.1007/s00737-013-0384-5
N.B. These documents automatically identified may not have been verified by the study sponsor.