Clinical Trial: Improve Detection and Management of Gestational Diabetes Through the Primary Health Care Level in Morocco

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary:

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

Detailed Summary:
Sponsor: Institute of Tropical Medicine, Belgium

Current Primary Outcome: Macrosomia [ Time Frame: within 6 months after being diagnosed with GDM ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Acceptance of GDM screening [ Time Frame: within 6 months after being diagnosed with GDM ]
    Assessing the acceptance GDM screening and initial management at primary health care level among providers and GDM affected women (Focus group discussions with providers and in-depth interviews with women affected by GDM)
  • Lifestyle impact of GDM [ Time Frame: within 6 months after being diagnosed with GDM ]
    Assessing the impact of GDM screening and management on women's life (questionnaire/ Likert-scales)


Original Secondary Outcome: Same as current

Information By: Institute of Tropical Medicine, Belgium

Dates:
Date Received: November 22, 2016
Date Started: November 2016
Date Completion: January 2018
Last Updated: November 29, 2016
Last Verified: November 2016