• Sex Reprod Healthc · Oct 2013

    Randomized Controlled Trial Comparative Study

    Group-based antenatal birth and parent preparation for improving birth outcomes and parenting resources: study protocol for a randomised trial.

    • Vibeke Koushede, Carina Sjöberg Brixval, Solveig Forberg Axelsen, Jane Lindschou, Per Winkel, Rikke Damkjær Maimburg, Pernille Due, and NEWBORN trial group.
    • National Institute of Public Health, University of Southern Denmark, Denmark. Electronic address: vibe@niph.dk.
    • Sex Reprod Healthc. 2013 Oct 1; 4 (3): 121-6.

    ObjectivesTo examine the efficacy and cost-effectiveness of group based antenatal education for improving childbirth and parenting resources compared to auditorium based education.MethodsParticipants2350 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 Outcomeuse of epidural analgesia.Secondary Outcomesstress, 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.ConclusionTo 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.Copyright © 2013 Elsevier B.V. All rights reserved.

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