title: Group-based antenatal birth and parent preparation for improving birth outcomes and parenting resources: study protocol for a randomised trial.
abstract: OBJECTIVE
  To examine the efficacy and cost-effectiveness of group based antenatal education for improving childbirth and parenting resources compared to auditorium based education.
  
  
  METHODS
  
  
  
  METHODS
  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.
  
  
  METHODS
  use of epidural analgesia.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.affiliation: National Institute of Public Health, University of Southern Denmark, Denmark. Electronic address: vibe@niph.dk.
authors.forename: Vibeke
authors.initials: V
authors.lastname: Koushede
authors.forename: Carina Sjöberg
authors.initials: CS
authors.lastname: Brixval
authors.forename: Solveig Forberg
authors.initials: SF
authors.lastname: Axelsen
authors.forename: Jane
authors.initials: J
authors.lastname: Lindschou
authors.forename: Per
authors.initials: P
authors.lastname: Winkel
authors.forename: Rikke Damkjær
authors.initials: RD
authors.lastname: Maimburg
authors.forename: Pernille
authors.initials: P
authors.lastname: Due
mesh_terms: D000328:Adult; D015360:Analgesia, Epidural / Q000706:statistics & numerical data*; D003362:Cost-Benefit Analysis; D003718:Denmark; D005260:Female; D006295:Health Resources; D006801:Humans; D010290:Parents; D010353:Patient Education as Topic / Q000379:methods*; D011247:Pregnancy; D011295:Prenatal Care / Q000379:methods*; D012107:Research Design; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
keywords: Antenatal preparation; Birth; Intervention research; Parenthood; Pregnancy; Randomised trial