Cost-Effectiveness of the Mindfulness-Based Childbirth and Parenting Program for Pregnant Women With Fear of Childbirth.

OBJECTIVE: To examine the cost-effectiveness of the Mindfulness-Based Childbirth and Parenting (MBCP) program compared with enhanced care as usual (ECAU). DESIGN: Randomized controlled trial. SETTING: Midwifery settings in the Netherlands, April 2014 to July 2017. PARTICIPANTS: Subset of pregnant women with high levels of fear of childbirth (N = 54: randomized to MBCP, n = 32, or to ECAU, n = 22) who were selected from the parent study because they completed all four cost questionnaires. METHODS: We measured self-reported health care and non-health care costs. A subset of participants from the parent study completed the questionnaires at all four assessment points. We used the Wijma Delivery Expectancy Questionnaire to measure fear of childbirth and used the EuroQol-5D to measure quality of life. We used these measures of effect together with societal costs in the primary cost-effectiveness analyses. In the secondary cost-effectiveness analyses, we used different estimates of effects and costs to test the robustness of the primary analyses. RESULTS: In all but one scenario, MBCP was more effective and cost less than ECAU. As indicated by the acceptability curves, the likelihood of MBCP being cost-effective varied within a range of 70% to 98%. CONCLUSION: Our findings indicate that MBCP is a cost-effective intervention to reduce fear of childbirth in pregnant women. Important next steps are to replicate the study in countries with different health care systems and to explore the potential for further integration of MBCP into midwifery care.

Fear of childbirth, nonurgent obstetric interventions, and newborn outcomes: A randomized controlled trial comparing mindfulness-based childbirth and parenting with enhanced care as usual.

OBJECTIVE: To investigate whether mindfulness-based childbirth and parenting (MBCP) or enhanced care as usual (ECAU) for expectant couples decreases fear of childbirth (FOC) and nonurgent obstetric interventions during labor and improves newborn outcomes. DESIGN: Randomized controlled trial. SETTING: Midwifery settings, the Netherlands, April 2014-July 2017. POPULATION: Pregnant women with high FOC (n = 141) and partners. METHODS: Allocation to MBCP or ECAU. Hierarchical multilevel and intention-to-treat (ITT) and per-protocol (PP) analyses. MAIN OUTCOME MEASURES: Primary: pre-/postintervention FOC, labor anxiety disorder, labor pain (catastrophizing and acceptance), and preferences for nonurgent obstetric interventions. Secondary: rates of epidural analgesia (EA), self-requested cesarean birth (sCB), unmedicated childbirth, and 1- and 5-minute newborn's Apgar scores. RESULTS: MBCP was significantly superior to ECAU in decreasing FOC, catastrophizing of labor pain, preference for nonurgent obstetric interventions, and increasing acceptance of labor pain. MBCP participants were 36% less likely to undergo EA (RR 0.64, 95% CI [0.43-0.96]), 51% less likely to undergo sCB (RR 0.49, 95% CI [0.36-0.67]), and twice as likely to have unmedicated childbirth relative to ECAU (RR 2.00, 95% CI [1.23-3.20]). Newborn's 1-minute Apgar scores were higher in MBCP (DM -0.39, 95% CI [-0.74 to -0.03]). After correction for multiple testing, results remained significant in ITT and PP analyses, except EA in ITT analyses and 1-minute Apgar. CONCLUSIONS: MBCP for pregnant couples reduces mothers' fear of childbirth, nonurgent obstetric interventions during childbirth and may improve childbirth outcomes. MBCP adapted for pregnant women with high FOC and their partners appears an acceptable and effective intervention for midwifery care.

'I've Changed My Mind', Mindfulness-Based Childbirth and Parenting (MBCP) for pregnant women with a high level of fear of childbirth and their partners: study protocol of the quasi-experimental controlled trial.

BACKGROUND: Approximately 25 % of pregnant women suffer from a high level of Fear of Childbirth (FoC), as assessed by the Wijma Delivery Expectancy Questionnaire (W-DEQ-A, score ≥66). FoC negatively affects pregnant women's mental health and adaptation to the perinatal period. Mindfulness-Based Childbirth and Parenting (MBCP) seems to be potentially effective in decreasing pregnancy-related anxiety and stress. We propose a theoretical model of Avoidance and Participation in Pregnancy, Birth and the Postpartum Period in order to explore FoC and to evaluate the underlying mechanisms of change of MBCP. METHODS/DESIGN: The 'I've Changed My Mind' study is a quasi-experimental controlled trial among 128 pregnant women (week 16-26) with a high level of FoC, and their partners. Women will be allocated to MBCP (intervention group) or to Fear of Childbirth Consultation (FoCC; comparison group). Primary outcomes are FoC, labour pain, and willingness to accept obstetrical interventions. Secondary outcomes are anxiety, depression, general stress, parental stress, quality of life, sleep quality, fatigue, satisfaction with childbirth, birth outcome, breastfeeding self-efficacy and cost-effectiveness. The total study duration for women is six months with four assessment waves: pre- and post-intervention, following the birth and closing the maternity leave period. DISCUSSION: Given the high prevalence and severe negative impact of FoC this study can be of major importance if statistically and clinically meaningful benefits are found. Among the strengths of this study are the clinical-based experimental design, the extensive cognitive-emotional and behavioural measurements in pregnant women and their partners during the entire perinatal period, and the representativeness of study sample as well as generalizability of the study's results. The complex and innovative measurements of FoC in this study are an important strength in clinical research on FoC not only in pregnant women but also in their partners. TRIAL REGISTRATION: Dutch Trial Register (NTR): NTR4302 , registration date the 3rd of December 2013.