Skip to main content
OpenTrials
Completed

NCT Number: NCT02979756

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Marrakesh, 40000, Morocco

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Decentralized GDM screening and initial management

Procedure

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

Primary outcomes

  1. Macrosomia

    Time frame: within 6 months after being diagnosed with GDM

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

Secondary outcomes

  1. Acceptance of GDM screening

    Time frame: within 6 months after being diagnosed with GDM

    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)

  2. Lifestyle impact of GDM

    Time frame: within 6 months after being diagnosed with GDM

    Assessing the impact of GDM screening and management on women's life (questionnaire/ Likert-scales)

Sponsors and collaborators

Lead sponsor

Institute of Tropical Medicine, Belgium

Other

Collaborators

  • Ecole Nationale de Santé Publique, Rabat, Morocco

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Dec 2, 2016
Registry last updated
Mar 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.