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

Gestational Diabetes Mellitus in Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02979756
• Other study ID #: ITMBelgium
• Status: Completed
• Phase: N/A
• First received: November 22, 2016
• Last updated: February 28, 2018
• Start date: November 14, 2016
• Est. completion date: February 12, 2018

Study information

• Verified date: February 2018
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: February 12, 2018
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus in Pregnancy
• Pregnancy in Diabetics

Intervention

Procedure:
• Decentralized GDM screening and initial management
Screening for GDM and initialization of nutritional therapy at the first level of care

Locations

Country	Name	City	State
Morocco	20 facilities in Marrakech and Al Haouz - Region Marrakech-Safi	Marrakech

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Tropical Medicine, Belgium	Ecole Nationale de Santé Publique, Rabat, Morocco

Country where clinical trial is conducted

Morocco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Acceptance of GDM screening	Assessing 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)	within 6 months after being diagnosed with GDM
Secondary	Lifestyle impact of GDM	Assessing the impact of GDM screening and management on women's life (questionnaire/ Likert-scales)	within 6 months after being diagnosed with GDM