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Trial registered on ANZCTR


Registration number
ACTRN12612000526875
Ethics application status
Approved
Date submitted
8/05/2012
Date registered
17/05/2012
Date last updated
18/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
BELIEF - Birth Emotions Looking to Improve Expectant or Extreme Fear
Scientific title
What is the effect of an antenatal midwife-led psycho-education intervention in reducing childbirth related fear in women reporting a high level of fear?
Secondary ID [1] 280455 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
BELIEF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High Childbirth fear 286435 0
Condition category
Condition code
Mental Health 286690 286690 0 0
Anxiety
Reproductive Health and Childbirth 286691 286691 0 0
Antenatal care
Reproductive Health and Childbirth 286692 286692 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase 1 is a RCT involving antenatal recruitment and screening of a large sample of women (n = 1200) early to mid second trimester of pregnancy. Women reporting high levels of fear will be randomly allocated to BELIEF or the control group. Women in the intervention group will receive two 1 hour telephone sessions of midwfe counselling (psycho-education) across the second and third trimester. Women in the control and intervention groups will be offered the same evidence-based consumer resource “Choosing how to birth your baby” developed by the Queensland Centre for Mothers and Babies (QCMB). Both groups will be followed up to 4 to 6 weeks postpartum.
Providing a control group that receives the same written evidence-based information provision establishes whether the counselling intervention accounts for the results. The intervention is targeted to those women reporting high levels of childbirth fear. Using practising midwives, who are trained and supervised to deliver BELIEF, maximises the translation of research findings into practice. The duration of Phase 1 is expected to be over a period of 20 months.

Phase 2 A within-trial cost-effectiveness analysis will be performed from the perspective of the health care system to compare the psycho-education intervention with active control treatment in pregnant women with high levels of fear. Costs will be assigned to each component of HSU using national sources of cost information (i.e. Medicare and AR-DRG costs). The additional costs and additional benefits from the intervention will be calculated as well as the incremental cost-effectiveness ratio (ICER). Sensitivity analyses will enable these estimates to be adjusted for expected cost reductions associated with increased use (more midwives being trained). Phase 2 will commence during Phase 1 around the 12th week of the study and conclude with Phase 1.

Phase 3 aims to identify any differences in the narratives of women’s antenatal experiences in the control and intervention group. A random sample of women will be interviewed to explore their childbirth fears and anxieties and how these influenced decisions about mode of birth. Participants receiving the intervention will also be asked to evaluate their experience of this. Phase 3 will occur in the last 4 months of Phase 1.
Intervention code [1] 284818 0
Early detection / Screening
Intervention code [2] 284819 0
Prevention
Intervention code [3] 284820 0
Behaviour
Comparator / control treatment
Women will receive Standard Care and an evidence-based consumer resource “Choosing how to birth your baby” developed by the Queensland Centre for Mothers and Babies (QCMB). Standard care is the usual public hospital maternity care women would receive had they not been participating in this study. The consumer resource will be posted to all women randomised to the study to assist them with determining their maternity options in Queensland.
Control group
Active

Outcomes
Primary outcome [1] 287086 0
Reduction in child birth fear as assessed by Wijma Delivery Expectations Questionaire (WDEQ).
Timepoint [1] 287086 0
At 36 weeks pregnancy and six weeks postnatal.
Secondary outcome [1] 297341 0
Improved confidence for birth will be assessed by Wijma Delivery Expectations Questionaire (WDEQ), Childbirth Self-Efficacy Inventory (CBSEI), Social Support/Persuasions Scale (SSPS), Childbirth Knowledge Scale (CKS), Decisional Conflict Scale (DCS) & Sense of Confidence and Satisfaction (PSOC - 12 items)
Timepoint [1] 297341 0
At 36 weeks pregnancy and six weeks postnatal.
Secondary outcome [2] 297342 0
Improved maternal and neonatal health outcomes will be assessed by Demographic, Reproductive & Health Questionnaire, Edinburgh Postnatal Depression Scale, Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ), Childbirth Self-Efficacy Inventory (CBSEI), Sense of Confidence and Satisfaction (PSOC - 12 items, EuroQol Questionnaire (EQ-5D), Postnatal Questionnaire & Health service use (HSU).
Timepoint [2] 297342 0
At 36 weeks pregnancy and six weeks postnatal.
Secondary outcome [3] 297343 0
Decreased need/use of health services will be assessed by the questionnaire: Health service use (HSU) and collection of healthcare costs, and information obtained from Medicare Australia for the period from 20 weeks gestation to 4 to 6 weeks follow-up. The diagnosis and Australian Refined Diagnostic Related Group (AR-DRG) will be collected for all reported admissions to hospital for the same period..
Timepoint [3] 297343 0
Through pregnancy to six weeks post birth

Eligibility
Key inclusion criteria
High childbirth fear (>66 score on WDEQ)
Minimum age
16 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Less than 16
Greater than 22 weeks pregnant
Not planning to birth at booking hospital
Inability to read or understand English
Not expecting to birth a live infant

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 eligible for inclusion in the study will be provided with a brief verbal overview and provided with written information outlining the study purpose by a research assistant. Women who have indicated an interest but not consented in the antenatal clinic will be followed up by telephone within 48 hours of their booking appointment. A computerised web based service will generate random numbers for allocation of the participants. Participants will be randomly assigned 1:1 allocation to one of two groups (control or intervention groups) and stratified by hospital and, by parity.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Parallel block randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Qualitative and economic analysis
Phase
Not Applicable
Type of endpoint(s)
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285217 0
Government body
Name [1] 285217 0
NHNRC
Address [1] 285217 0
NHMRC national Health and Medical Research Council
GPO Box 1421
Canberra, ACT 26-1
Country [1] 285217 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
170 Kessels Road
Nathan, Queensland, 4111
Country
Australia
Secondary sponsor category [1] 284088 0
Hospital
Name [1] 284088 0
Gold Coast Hospital
Address [1] 284088 0
8 Little High Street
Southport, Queensland 4215
Country [1] 284088 0
Australia
Other collaborator category [1] 260793 0
Hospital
Name [1] 260793 0
Logan Hospital
Address [1] 260793 0
cnr Armstrong & Lo0ganlea Roads
Meadowbrook, Queensland, 4131
Country [1] 260793 0
Australia
Other collaborator category [2] 260794 0
Hospital
Name [2] 260794 0
Redland Hospital
Address [2] 260794 0
Weippin Street
Cleveland, Queensland 4163
Country [2] 260794 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287220 0
Office of the Human Research Ethics Committee Gold Coast Hospital
Ethics committee address [1] 287220 0
8 Little High Street
Southport, Queensland 4215
Ethics committee country [1] 287220 0
Australia
Date submitted for ethics approval [1] 287220 0
Approval date [1] 287220 0
02/12/2011
Ethics approval number [1] 287220 0
HREC/11/QGC/162
Ethics committee name [2] 287221 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 287221 0
Office for Research
Building 39, Room 3.55
Gold Coast Campus
Griffith University Parklands
Gold Coast, Queensland 4215
Ethics committee country [2] 287221 0
Australia
Date submitted for ethics approval [2] 287221 0
Approval date [2] 287221 0
08/12/2011
Ethics approval number [2] 287221 0
NRS-45-11-HREC

Summary
Brief summary
We will conduct a program of work that includes a randomised controlled trial (RCT) of the psychoeducation counselling intervention (Phase 1), an economic evaluation (Phase 2) and a qualitative investigation (Phase 3). Phase 1 will determine the efficacy of a mid-wife-led psycho-education counseling intervention to address women's childbirth fear and enhance confidence. The intervention aims to assist women to identify and work through distressing and/or fearful elements of childbirth, review their expectations and/or previous birth experiences, and understand their birth choices. Phase 2 intends to assess the cost effectiveness of the intervention relative to maternal and neonatal outcomes. Phase 3 aims to identify any differences in the narratives of women's antenatal experiences in the control and intervention group. A random sample of women will be interviewed to explore their childbirth fears and anxieties and how these influences decisions about mode of birth. Participants will also be asked to evaluate their experience of the intervention.

Design: We will conduct a randomized controlled trial (RCT) of a psychoeducation intervention (Phase1) , an economic evaluation (Phase 2) and a qualitative investigation (Phase 3).

Hypotheses: Relative to women allocated to the control group, women receiving the intervention will (1) report lower levels of childbirth fear, anxiety and depression at term; (2) have high confidence and self efficacy in their ability to give birth ; and (3) demonstrate superior outcomes on mental health indices and adjustment to motherhood in the postpartum period.

Outcome Measures: The primary outcome measure will be a reduction in childbirth fear. Secondary outcomes include improved confidence to give birth, childbirth self-efficacy, social support, decisional conflict, obstetric and mental health outcomes, maternal and neonatal outcomes, quality of life and use of health services.

Setting: Antenatal clinics of Gold Coast, Logan and Redland Hospitals.

Sample and Sample Size: Pregnant women in their 2nd trimester (12-22 weeks) will be invited to participate. A sample size of 150 participants in each group is required (recruitment approx n=1200 women for assessment of birth fear prior to randomization). Around 40 women (20 from each group) will be randomly selected and invited to participate in an in-depth interview about their experiences (Phase 3).

Inclusion Criteria: All women attending the antenatal clinics of participating sites in the second trimester of pregnancy will be invited to participate. They must be able to communicate sufficiently to discuss their concerns about birth and be 16 years or older. Those participants reporting high fear of childbirth on the W-DEQ will be randomised.


Exclusion Criteria: If after recruitment women come to expect a perinatal death (e.g. congenital abnormality incompatible) or stillbirth they will be given an opportunity to withdraw from the study. If they opt to continue they will be offered counselling support and receive newsletters if they request. Follow up questionnaires containing parenting questions will not be administered.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34150 0
Address 34150 0
Country 34150 0
Phone 34150 0
Fax 34150 0
Email 34150 0
Contact person for public queries
Name 17397 0
Jocelyn Toohill
Address 17397 0
Building L05, Room 3.58
Griffith University
University Drive
Meadowbrook, Queensland 4131
Country 17397 0
Australia
Phone 17397 0
+61 423347378
Fax 17397 0
Email 17397 0
j.toohill@griffith.edu.au
Contact person for scientific queries
Name 8325 0
Jocelyn Toohill
Address 8325 0
Building L05, Room 3.58
Griffith University
University Drive
Meadowbrook, Queensland 4131
Country 8325 0
Australia
Phone 8325 0
+61 423347378
Fax 8325 0
Email 8325 0
j.toohill@griffith.edu.au

No information has been provided regarding IPD availability
Summary results
No Results