None listed
Conditions
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.
Interventions
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 “C
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.
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
High childbirth fear (>66 score on WDEQ)
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
Outcome results
None listed