Clinical trial NCT02979756: Improve Detection and Management of Gestational Diabetes Through the Primary Health Care Level in Morocco
Official title: Améliorer la Detection et la Prise en Charge du diabète Gestationnel au Niveau Des établissements de Soins de santé Primaires au Maroc
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
Collaborators: name: Ecole Nationale de Santé Publique, Rabat, Morocco
First posted: 2016-12-02
Enrollment: 215
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: Macrosomia
timeFrame: within 6 months after being diagnosed with GDM
Secondary outcomes:
measure: Acceptance of GDM screening
timeFrame: within 6 months after being diagnosed with GDM
measure: Lifestyle impact of GDM
timeFrame: within 6 months after being diagnosed with GDM
Other outcomes:
Locations:
city: Marrakech
country: Morocco
facility: 20 facilities in Marrakech and Al Haouz - Region Marrakech-Safi
Study officials:
affiliation: Ecole Nationale de Santé Publique, Rabat, Morocco
name: Bouchra Assarag, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Tropical Medicine, Antwerp, Belgium
name: Bettina Utz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Tropical Medicine, Antwerp, Belgium
name: Vincent De Brouwere, MD
role: STUDY_DIRECTOR
References:
citation: Utz B, Assarag B, Lekhal T, Van Damme W, De Brouwere V. Implementation of a new program of gestational diabetes screening and management in Morocco: a qualitative exploration of health workers' perceptions. BMC Pregnancy Childbirth. 2020 May 24;20(1):315. doi: 10.1186/s12884-020-02979-9.
citation: Utz B, Assarag B, Smekens T, Ennassiri H, Lekhal T, El Ansari N, Fakhir B, Barkat A, Essolbi A, De Brouwere V. Detection and initial management of gestational diabetes through primary health care services in Morocco: An effectiveness-implementation trial. PLoS One. 2018 Dec 28;13(12):e0209322. doi: 10.1371/journal.pone.0209322. eCollection 2018.
citation: Utz B, Assarag B, Essolbi A, Barkat A, El Ansari N, Fakhir B, Delamou A, De Brouwere V. Improving detection and initial management of gestational diabetes through the primary level of care in Morocco: protocol for a cluster randomized controlled trial. Reprod Health. 2017 Jun 19;14(1):75. doi: 10.1186/s12978-017-0336-z.