Ayerle Gertrud M, Schäfers Rainhild, Mattern Elke, Striebich Sabine, Haastert Burkhard, Vomhof Markus, Icks Andrea, Ronniger Yvonne, Seliger Gregor
Institute of Health and Nursing Science, Medical Faculty of the Martin Luther University Halle-Wittenberg, Magdeburger Str. 8, 06112, Halle (Saale), Germany.
Department of Health Science, Hochschule für Gesundheit - University of Applied Sciences, Gesundheitscampus 6-8, 44801, Bochum, Germany.
Trials. 2018 Nov 19;19(1):641. doi: 10.1186/s13063-018-2979-7.
Caesarean sections (CSs) are associated with increased risk for maternal morbidity and mortality. The recommendations of the recently published German national health goal 'Health in Childbirth' (Gesundheit rund um die Geburt) promote vaginal births (VBs). This randomised controlled trial (RCT) evaluates the effects of a complex intervention pertaining to the birth environment, based on the sociology of technical artefacts and symbolic interactionism. The intervention is intended to foster an upright position and mobility during labour, which lead to a higher probability of VB.
METHODS/DESIGN: This study is an active controlled superiority trial with a two-arm parallel design. The complex intervention involves making changes to the birthing room to encourage an upright position and mobility of women in labour and to relax them, which may help them to cope with labour and may increase self-determination. This may result in more VBs. Included in the study are primiparae and multiparae with a singleton foetus in cephalic presentation at term planning a VB. According to the sample size calculation, 3800 women in 12 obstetrical units are to be included. Randomisation will be performed centrally and controlled by an independent coordination centre. Blinding of participants and staff is not possible. Key outcomes are VB, episiotomy, perineal tears, epidural analgesia, critical outcome of newborn at term and maternal self-determination during birth. Additionally, a health economic evaluation will be performed.
This is the first adequately powered multicentre RCT examining the effect of a redesigned birthing room on the probability of a VB and patient-centred physical and emotional outcomes. An increase in the number of VBs by 5% from a baseline of 74% to 79% would result in 21,000 women per year experiencing a VB rather than a CS in Germany. Expected benefits are greater self-determination during labour, improved physical and emotional client-centred outcomes, fewer medical interventions and a reduction in health-care costs.
German Clinical Trials Register (Deutsches Register Klinischer Studien), DRKS00012854 . Registered on 7 March 2018.
剖宫产与孕产妇发病和死亡风险增加相关。最近发布的德国国家卫生目标“分娩健康”（Gesundheit rund um die Geburt）的建议提倡阴道分娩。这项随机对照试验（RCT）基于技术人工制品社会学和符号互动主义，评估了一项与分娩环境有关的复杂干预措施的效果。该干预旨在促进分娩期间的直立姿势和活动能力，从而提高阴道分娩的概率。
方法/设计：本研究是一项采用双臂平行设计的主动对照优势试验。复杂干预措施包括对分娩室进行改造，以鼓励分娩中的妇女采取直立姿势并活动起来，使其放松，这可能有助于她们应对分娩并增强自主决定权。这可能会带来更多的阴道分娩。纳入研究的是计划进行阴道分娩的足月单胎头先露初产妇和经产妇。根据样本量计算，将纳入12个产科单位的3800名妇女。随机分组将由独立协调中心集中进行并控制。无法对参与者和工作人员进行盲法。主要结局指标为阴道分娩、会阴切开术、会阴撕裂、硬膜外镇痛、足月新生儿关键结局以及分娩期间的产妇自主决定权。此外，还将进行健康经济学评估。
这是第一项有足够样本量的多中心随机对照试验，研究重新设计的分娩室对阴道分娩概率以及以患者为中心的身体和情感结局的影响。在德国，若阴道分娩数量从基线的74%增加5%至79%将意味着每年有21000名妇女选择阴道分娩而非剖宫产。预期益处包括分娩期间更大的自主决定权、以患者为中心的身体和情感结局得到改善、医疗干预减少以及医疗保健成本降低。
德国临床试验注册中心（Deutsches Register Klinischer Studien），DRKS00012854。于2018年3月7日注册。
