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

NCT02979756 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2018-03-01

No results posted yet for this study

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.

Conditions

  • Gestational Diabetes Mellitus in Pregnancy

Interventions

PROCEDURE

Decentralized GDM screening and initial management

Screening for GDM and initialization of nutritional therapy at the first level of care

Sponsors & Collaborators

  • Ecole Nationale de Santé Publique, Rabat, Morocco

    collaborator UNKNOWN
  • Institute of Tropical Medicine, Belgium

    lead OTHER

Principal Investigators

  • Bouchra Assarag, MD · Ecole Nationale de Santé Publique, Rabat, Morocco

  • Bettina Utz, MD · Institute of Tropical Medicine, Antwerp, Belgium

  • Vincent De Brouwere, MD · Institute of Tropical Medicine, Antwerp, Belgium

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-14
Primary Completion
2017-12-15
Completion
2018-02-12

Countries

  • Morocco

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02979756 on ClinicalTrials.gov