Utz Bettina, Assarag Bouchra, Essolbi Amina, Barkat Amina, El Ansari Nawal, Fakhir Bouchra, Delamou Alexandre, De Brouwere Vincent
Institute of Tropical Medicine, Antwerp, Belgium.
National School of Public Health, Rabat, Morocco.
Reprod Health. 2017 Jun 19;14(1):75. doi: 10.1186/s12978-017-0336-z.
Morocco is facing a growing prevalence of diabetes and according to latest figures of the World Health Organization, already 12.4% of the population are affected. A similar prevalence has been reported for gestational diabetes (GDM) and although it is not yet high on the national agenda, immediate and long-term complications threaten the health of mothers and future generations. A situational analysis on GDM conducted in 2015 revealed difficulties in access to screening and delays in receiving appropriate care. This implementation study has as objective to evaluate a decentralized GDM detection and management approach through the primary level of care and assess its potential for scaling up.
We will conduct a hybrid effectiveness-implementation research using a cluster randomized controlled trial design in two districts of Morocco. Using the health center as unit of randomization we randomly selected 20 health centers with 10 serving as intervention and 10 as control facilities. In the intervention arm, providers will screen pregnant women attending antenatal care for GDM by capillary glucose testing during antenatal care. Women tested positive will receive nutritional counselling and will be followed up through the health center. In the control facilities, screening and initial management of GDM will follow standard practice. Primary outcome will be birthweight with weight gain during pregnancy, average glucose levels and pregnancy outcomes including mode of delivery, presence or absence of obstetric or newborn complications and the prevalence of GDM at health center level as secondary outcomes. Furthermore we will assess the quality of life /care experienced by the women in both arms. Qualitative methods will be applied to evaluate the feasibility of the intervention at primary level and its adoption by the health care providers.
In Morocco, gestational diabetes screening and its initial management is fragmented and coupled with difficulties in access and treatment delays. Implementation of a strategy that enables detection, management and follow-up of affected women at primary health care level is expected to positively impact on access to care and medical outcomes.
The trial has been registered on clininicaltrials.gov ; identifier NCT02979756 ; retrospectively registered 22 November 2016.
摩洛哥糖尿病患病率呈上升趋势，根据世界卫生组织的最新数据，该国已有12.4%的人口受糖尿病影响。妊娠糖尿病（GDM）的患病率与之相似，尽管它尚未成为国家议程上的重点问题，但近期和远期并发症都威胁着母亲和后代的健康。2015年开展的一项关于GDM的现状分析显示，在筛查服务的可及性以及获得适当治疗方面存在困难。本实施性研究旨在评估通过基层医疗保健机构进行GDM检测与管理的分散式方法，并评估其扩大规模的潜力。
我们将在摩洛哥的两个地区采用整群随机对照试验设计开展一项有效性与实施性混合研究。以卫生中心作为随机分组单位，我们随机选取了20个卫生中心，其中10个作为干预组，10个作为对照组。在干预组中，医护人员将在产前检查时通过毛细血管血糖检测对参加产前护理的孕妇进行GDM筛查。检测呈阳性的女性将接受营养咨询，并通过卫生中心进行随访。在对照组中，GDM的筛查和初始管理将遵循标准流程。主要结局指标为出生体重及孕期体重增加情况、平均血糖水平以及包括分娩方式、是否存在产科或新生儿并发症等在内的妊娠结局，卫生中心层面的GDM患病率作为次要结局指标。此外，我们将评估两组女性的生活质量/所接受护理的情况。将采用定性方法评估该干预措施在基层的可行性以及医护人员对其的接受程度。
在摩洛哥，妊娠糖尿病筛查及其初始管理较为分散，且存在服务可及性困难和治疗延误的问题。实施一项能够在初级卫生保健层面实现对受影响女性的检测、管理及随访的策略，有望对医疗服务可及性和医疗结局产生积极影响。
该试验已在clinicaltrials.gov上注册；标识符为NCT02979756；于2016年11月22日进行回顾性注册。
