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

Not Applicable

Completed

• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Interventions: Procedure: Decentralized GDM screening and initial management

• Registration Number: NCT02979756
• Lead Sponsor: Institute of Tropical Medicine, Belgium

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 the lifestyle of affected mothers.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-14
• Study First Submitted: 2016-11-22
• Study First Submitted QC: 2016-11-29
• Study First Posted: 2016-12-02
• Primary Completion: 2017-12-15
• Status Verified: 2018-02
• Study Completion: 2018-02-12
• Last Update Submitted: 2018-02-28
• Last Update Posted: 2018-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 215

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Decentralized GDM screening and initial management	Decentralized GDM screening and initial management	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.

Primary Outcome Measures

Name	Time	Method
Macrosomia	within 6 months after being diagnosed with GDM	Difference in birth weight of babies of mothers detected with GDM in the different arms

Secondary Outcome Measures

Name	Time	Method
Acceptance of GDM screening	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	within 6 months after being diagnosed with GDM	Assessing the impact of GDM screening and management on women's life (questionnaire/ Likert-scales)

Trial Locations

Locations (1)

20 facilities in Marrakech and Al Haouz - Region Marrakech-Safi; 🇲🇦 Marrakech, Morocco