van Voorst Sabine F, Vos Amber A, de Jong-Potjer Lieke C, Waelput Adja J M, Steegers Eric A P, Denktas Semiha
Department of Obstetrics and Gynaecology, Division of Obstetrics & Prenatal Medicine, Erasmus MC, Rotterdam, The Netherlands.
Department of Obstetrics and Gynaecology, Division of Obstetrics & Prenatal Medicine, Erasmus MC, Rotterdam, The Netherlands Department of Social and Behavioural Sciences, Erasmus University College, Erasmus University Rotterdam, Rotterdam, The Netherlands.
BMJ Open. 2015 Mar 20;5(3):e006284. doi: 10.1136/bmjopen-2014-006284.
Promotion of healthy pregnancies has gained high priority in the Netherlands because of the relative unfavourable perinatal outcomes. In response, a nationwide study Healthy Pregnancy 4 All (HP4ALL) has been initiated. One of the substudies within HP4ALL focuses on preconception care (PCC). PCC is an opportunity to detect and eliminate risk factors before conception to optimise health before organogenesis and placentation. The main objectives of the PCC substudy are (1) to assess the effectiveness of a recruitment strategy for the PCC health services and (2) to assess the effectiveness of individual PCC consultations.
METHODS/ANALYSIS: Prospective cohort study in neighbourhoods of 14 municipalities with perinatal mortality and morbidity rates exceeding the nation's average. The theoretical framework of the PCC substudy is based on Andersen's model of healthcare utilisation (a model that evaluates the utilisation of healthcare services from a sociological perspective). Women aged 18 up to and including 41 years are targeted for utilisation of the PCC health service by a four armed recruitment strategy. The PCC health service consists of an individual PCC consultation consisting of (1) initial risk assessment and risk management and (2) a follow-up consultation to assess adherence to the management plan. The primary outcomes regarding the effectiveness of consultations is behavioural change regarding folic acid supplementation, smoking cessation, cessation of alcohol consumption and illicit substance use. The primary outcome regarding the effectiveness of the recruitment strategy is the number of women successfully recruited and the outreach in terms of which population is reached in comparison to the approached population. Data collection consists of registration in the database of women that enrol for a visit to the individual PCC consultations (women successfully recruited), and preconsultation and postconsultation measurements among the included study population (by questionnaires, anthropometric measurements and biomarkers). Sample size calculation resulted in a sample size of n=839 women.
Approval for this study has been obtained from the Medical Ethical Committee of the Erasmus Medical Center of Rotterdam (MEC 2012-425). Results will be published and presented at international conferences.
由于围产期结局相对不佳，促进健康妊娠在荷兰已成为高度优先事项。作为回应，一项全国性研究“全民健康妊娠（HP4ALL）”已经启动。HP4ALL中的一项子研究聚焦于孕前保健（PCC）。PCC是在受孕前检测并消除风险因素的契机，以便在器官形成和胎盘形成之前优化健康状况。PCC子研究的主要目标是：（1）评估PCC健康服务招募策略的有效性；（2）评估个体PCC咨询的有效性。
方法/分析：在14个市的社区开展前瞻性队列研究，这些社区的围产期死亡率和发病率超过全国平均水平。PCC子研究的理论框架基于安德森医疗保健利用模型（一个从社会学角度评估医疗保健服务利用情况的模型）。采用四臂招募策略，将18岁至41岁的女性作为PCC健康服务的目标人群。PCC健康服务包括一次个体PCC咨询，该咨询由（1）初始风险评估与风险管理，以及（2）一次随访咨询组成，以评估对管理计划的依从性。关于咨询有效性的主要结局是叶酸补充、戒烟、戒酒和停止使用非法物质方面的行为改变。关于招募策略有效性的主要结局是成功招募的女性数量，以及与所接触人群相比所覆盖的人群范围。数据收集包括在报名参加个体PCC咨询的女性数据库中进行登记（成功招募的女性），以及在纳入研究的人群中进行咨询前和咨询后的测量（通过问卷调查、人体测量和生物标志物）。样本量计算得出样本量为n = 839名女性。
本研究已获得鹿特丹伊拉斯姆斯医学中心医学伦理委员会的批准（MEC 2012 - 425）。研究结果将在国际会议上发表和展示。
