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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02979756
Enrollment
215
Registered
2016-12-02
Start date
2016-11-14
Completion date
2018-02-12
Last updated
2018-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes Mellitus in Pregnancy

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.

Interventions

PROCEDUREDecentralized GDM screening and initial management

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

Sponsors

Ecole Nationale de Santé Publique, Rabat, Morocco
CollaboratorUNKNOWN
Institute of Tropical Medicine, Belgium
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Macrosomiawithin 6 months after being diagnosed with GDMDifference in birth weight of babies of mothers detected with GDM in the different arms

Secondary

MeasureTime frameDescription
Acceptance of GDM screeningwithin 6 months after being diagnosed with GDMAssessing 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 GDMwithin 6 months after being diagnosed with GDMAssessing the impact of GDM screening and management on women's life (questionnaire/ Likert-scales)

Countries

Morocco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026