OBJECTIVES: To examine the efficacy and cost-effectiveness of group based antenatal education for improving childbirth and parenting resources compared to auditorium based education. PARTICIPANTS: 2350 Danish pregnant women and their partners≥18 years old, recruited before 20+0 gestational weeks. Population-based individually randomised superiority trial with two parallel arms: Four sessions of birth and parent preparation in small groups (experimental group); two lectures in an auditorium (control group). Data is collected by (1) questionnaires at baseline (≈18 weeks of gestation), 37 weeks of gestation, 9 weeks-, 6 months-, and 1 year post-partum, (2) the hospital obstetric database, (3) national registers. PRIMARY OUTCOME: use of epidural analgesia. SECONDARY OUTCOMES: stress, parenting alliance; explorative outcomes: depressive symptoms, use of health care services, self-efficacy, well-being, family break-ups. Analyses will be intention-to-treat as well as per protocol. Process evaluation will be conducted using questionnaires and qualitative interviews. The incremental societal cost of the intervention will be computed and compared to the measured outcomes in a cost-effectiveness analysis. CONCLUSION: To the best of our knowledge this is the largest well-designed randomised trial of its kind to date. The trial will bring much-needed evidence for decision makers of the content and form of antenatal education.
RCT Entities:
OBJECTIVES: To examine the efficacy and cost-effectiveness of group based antenatal education for improving childbirth and parenting resources compared to auditorium based education. PARTICIPANTS: 2350 Danish pregnant women and their partners ≥18 years old, recruited before 20+0 gestational weeks. Population-based individually randomised superiority trial with two parallel arms: Four sessions of birth and parent preparation in small groups (experimental group); two lectures in an auditorium (control group). Data is collected by (1) questionnaires at baseline (≈18 weeks of gestation), 37 weeks of gestation, 9 weeks-, 6 months-, and 1 year post-partum, (2) the hospital obstetric database, (3) national registers. PRIMARY OUTCOME: use of epidural analgesia. SECONDARY OUTCOMES: stress, parenting alliance; explorative outcomes: depressive symptoms, use of health care services, self-efficacy, well-being, family break-ups. Analyses will be intention-to-treat as well as per protocol. Process evaluation will be conducted using questionnaires and qualitative interviews. The incremental societal cost of the intervention will be computed and compared to the measured outcomes in a cost-effectiveness analysis. CONCLUSION: To the best of our knowledge this is the largest well-designed randomised trial of its kind to date. The trial will bring much-needed evidence for decision makers of the content and form of antenatal education.
Authors: Vibeke Koushede; Carina Sjöberg Brixval; Lau Caspar Thygesen; Solveig Forberg Axelsen; Per Winkel; Jane Lindschou; Christian Gluud; Pernille Due Journal: PLoS One Date: 2017-05-02 Impact factor: 3.240
Authors: Carina Sjöberg Brixval; Lau Caspar Thygesen; Solveig Forberg Axelsen; Christian Gluud; Per Winkel; Jane Lindschou; Tom Weber; Pernille Due; Vibeke Koushede Journal: BMJ Open Date: 2016-06-10 Impact factor: 2.692