NCT02979756

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

Completed NA Last updated 1 March 2018

What this trial tests

NA trial testing Decentralized GDM screening and initial management in Gestational Diabetes Mellitus in Pregnancy in 215 participants. Completed in 12 February 2018.

Timeline

14 November 2016

Primary endpoint
15 December 2017

12 February 2018

Quick facts

Lead sponsor	Institute of Tropical Medicine, Belgium
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	screening
Enrollment	215
Start date	14 November 2016
Primary completion	15 December 2017
Estimated completion	12 February 2018
Sites	1 location across Morocco

Drugs / interventions tested

• Decentralized GDM screening and initial management

Conditions studied

• Gestational Diabetes Mellitus in Pregnancy — all drugs for Gestational Diabetes Mellitus in Pregnancy →

Sponsor

Institute of Tropical Medicine, Belgium

Who can join

18 and older, female only, with Gestational Diabetes Mellitus in Pregnancy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Screening for gestational diabetes mellitus based on different risk profiles and settings for improving maternal and infant health.
   Tieu J, McPhee AJ, Crowther CA, Middleton P, et al · · 2017 · cited 42× · PMID 28771289 · DOI 10.1002/14651858.cd007222.pub4
2. Detection and initial management of gestational diabetes through primary health care services in Morocco: An effectiveness-implementation trial.
   Utz B, Assarag B, Smekens T, Ennassiri H, et al · · 2018 · cited 19× · PMID 30592751 · DOI 10.1371/journal.pone.0209322
3. Implementation of a new program of gestational diabetes screening and management in Morocco: a qualitative exploration of health workers' perceptions.
   Utz B, Assarag B, Lekhal T, Van Damme W, et al · · 2020 · cited 10× · PMID 32448233 · DOI 10.1186/s12884-020-02979-9
4. Improving detection and initial management of gestational diabetes through the primary level of care in Morocco: protocol for a cluster randomized controlled trial.
   Utz B, Assarag B, Essolbi A, Barkat A, et al · · 2017 · cited 6× · PMID 28629468 · DOI 10.1186/s12978-017-0336-z