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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]

Nil

Universal Trial Number (UTN)

Nil

Trial acronym

BELIEF

Linked study record

Health condition

Health condition(s) or problem(s) studied:

High Childbirth fear

Condition category

Condition code

Mental Health

Anxiety

Reproductive Health and Childbirth

Antenatal care

Reproductive Health and Childbirth

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]

Early detection / Screening

Intervention code [2]

Prevention

Intervention code [3]

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]

Reduction in child birth fear as assessed by Wijma Delivery Expectations Questionaire (WDEQ).

Timepoint [1]

At 36 weeks pregnancy and six weeks postnatal.

Secondary outcome [1]

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]

At 36 weeks pregnancy and six weeks postnatal.

Secondary outcome [2]

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]

At 36 weeks pregnancy and six weeks postnatal.

Secondary outcome [3]

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]

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

Sex

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

30/04/2012

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

300

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHNRC

Address [1]

NHMRC national Health and Medical Research Council
GPO Box 1421
Canberra, ACT 26-1

Country [1]

Australia

Primary sponsor type

University

Name

Griffith University

Address

170 Kessels Road
Nathan, Queensland, 4111

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Gold Coast Hospital

Address [1]

8 Little High Street
Southport, Queensland 4215

Country [1]

Australia

Other collaborator category [1]

Hospital

Name [1]

Logan Hospital

Address [1]

cnr Armstrong & Lo0ganlea Roads
Meadowbrook, Queensland, 4131

Country [1]

Australia

Other collaborator category [2]

Hospital

Name [2]

Redland Hospital

Address [2]

Weippin Street
Cleveland, Queensland 4163

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Office of the Human Research Ethics Committee Gold Coast Hospital

Ethics committee address [1]

8 Little High Street
Southport, Queensland 4215

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

02/12/2011

Ethics approval number [1]

HREC/11/QGC/162

Ethics committee name [2]

Griffith University Human Research Ethics Committee

Ethics committee address [2]

Office for Research
Building 39, Room 3.55
Gold Coast Campus
Griffith University Parklands
Gold Coast, Queensland 4215

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

08/12/2011

Ethics approval number [2]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Jocelyn Toohill

Address

Building L05, Room 3.58
Griffith University
University Drive
Meadowbrook, Queensland 4131

Country

Australia

Phone

+61 423347378

Fax

j.toohill@griffith.edu.au

Contact person for scientific queries

Name

Jocelyn Toohill

Address

Building L05, Room 3.58
Griffith University
University Drive
Meadowbrook, Queensland 4131

Country

Australia

Phone

+61 423347378

Fax

j.toohill@griffith.edu.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

Source	Title	Year of Publication	DOI
Dimensions AI	Study protocol for reducing childbirth fear: a midwife-led psycho-education intervention	2013	https://doi.org/10.1186/1471-2393-13-190
Embase	A randomized controlled trial of a psycho-education intervention by midwives in reducing childbirth fear in pregnant women.	2014	https://dx.doi.org/10.1111/birt.12136
Dimensions AI	Prevalence of childbirth fear in an Australian sample of pregnant women	2014	https://doi.org/10.1186/1471-2393-14-275
Embase	Factors associated with childbirth self-efficacy in Australian childbearing women.	2015	https://dx.doi.org/10.1186/s12884-015-0465-8
Dimensions AI	Identifying women who are afraid of giving birth: A comparison of the fear of birth scale with the WDEQ-A in a large Australian cohort	2015	https://doi.org/10.1016/j.srhc.2015.05.002

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically