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临床试验/NCT02979756
NCT02979756已完成不适用

Améliorer la Detection et la Prise en Charge du diabète Gestationnel au Niveau Des établissements de Soins de santé Primaires au Maroc

Institute of Tropical Medicine, Belgium2 个研究点 分布在 1 个国家目标入组 215 人开始时间: 2016年11月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
215
试验地点
2
主要终点
Macrosomia

研究概览

简要总结

A situational analysis on gestational diabetes conducted in 2015 in two districts in Morocco revealed difficulties in accessing screening for gestational diabetes (GDM) and delays in receiving appropriate care. Based on the results of the situational analysis, the investigators developed this proposal in close collaboration with the Moroccan research group on gestational diabetes composed of representatives of the Ministry of Health, researchers, members of professional organizations and specialists in the domains of endocrinology, gynecology, neonatal health and nutrition. The investigators opted for an hybrid implementation effectiveness trial to evaluate both clinical effectiveness of the proposed screening and initial management strategy and its implementation at the first level of care.

The objectives of this study are thus to evaluate the feasibility of a decentralized strategy of screening for GDM and the initialization of GDM treatment already through the primary level of care and to assess its potential for scaling-up. Specific objectives of this study are to augment universal access to screening and management of gestational diabetes and to increase the competencies of health care providers at first level health care facilities to detect, start initial treatment and to improve follow-up of affected women. By comparing active screening and treatment initiation through first line health facilities with the existing practices, the investigators would like to explore the effect of the new model on maternal and newborn outcomes such as weight gain in pregnancy, occurrence of delivery complications and birth weight. The investigators will further assess the acceptability of screening and initial management of GDM through first line health services by health care providers and by pregnant women diagnosed with GDM and the impact of two different screening approaches on the lifestyle of affected mothers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women attending ANC (screening)
  • Women diagnosed with GDM (follow-up)
  • Informed consent

排除标准

  • Pregnant women with pre-existing diabetes type 1 or 2
  • No informed consent

研究组 & 干预措施

Decentralized GDM screening and initial management

Experimental

In this arm, the intervention consists of screening all pregnant women for GDM using the nationally recommended oral glucose tolerance test that will take place during antenatal care consultations in 10 randomly selected primary health care facilities. Overall, 80 women who are diagnosed with GDM and who consent to participate will receive initial nutritional counseling and will be closely followed up.

干预措施: Decentralized GDM screening and initial management (Procedure)

Standard GDM screening and management practice

No Intervention

In this arm, screening for GDM will follow standard practice. 80 women diagnosed with GDM in 10 randomly selected primary health care facilities and who consent to participate will be followed up.

结局指标

主要结局

Macrosomia

时间窗: within 6 months after being diagnosed with GDM

Difference in birth weight of babies of mothers detected with GDM in the different arms

次要结局

  • Acceptance of GDM screening(within 6 months after being diagnosed with GDM)
  • Lifestyle impact of GDM(within 6 months after being diagnosed with GDM)

研究者

发起方
Institute of Tropical Medicine, Belgium
申办方类型
Other
责任方
Sponsor

研究点 (2)

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