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

NCT02979756 | Completed DMC

• 1 other identifier: ITMBelgium
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus in Pregnancy

Outcome Measures

Primary Outcomes (1)

• Macrosomia

  Difference in birth weight of babies of mothers detected with GDM in the different arms

  within 6 months after being diagnosed with GDM

Secondary Outcomes (2)

• Acceptance of GDM screening

  within 6 months after being diagnosed with GDM

• Lifestyle impact of GDM

  within 6 months after being diagnosed with GDM

Study Arms (2)

Decentralized GDM screening and initial management

EXPERIMENTAL

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.

Procedure: Decentralized GDM screening and initial management

Standard GDM screening and management practice

NO INTERVENTION

In this arm, screening for GDM will follow standard practice. 80 women diagnosed with GDM in 10 randomly selected primary health care facilities and who consent to participate will be followed up.

Interventions

Decentralized GDM screening and initial management PROCEDURE

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

Decentralized GDM screening and initial management

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• Ecole Nationale de Santé Publique, Rabat, Morocco: collaborator

Study Sites (1)

20 facilities in Marrakech and Al Haouz - Region Marrakech-Safi

Marrakesh, 40000, Morocco

Location

Related Publications (3)

• 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.

  PMID: 32448233 DERIVED

• 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.

  PMID: 30592751 DERIVED

• 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.

  PMID: 28629468 DERIVED

Study Officials

• Bouchra Assarag, MD

  Ecole Nationale de Santé Publique, Rabat, Morocco

  PRINCIPAL INVESTIGATOR

• Bettina Utz, MD

  Institute of Tropical Medicine, Antwerp, Belgium

  PRINCIPAL INVESTIGATOR

• Vincent De Brouwere, MD

  Institute of Tropical Medicine, Antwerp, Belgium

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: December 2, 2016
• Study Start: November 14, 2016
• Primary Completion: December 15, 2017
• Study Completion: February 12, 2018
• Last Updated: March 1, 2018

Record last verified: 2018-02

Locations

MO (1)