search
Back to results

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

Primary Purpose

Gestational Diabetes Mellitus in Pregnancy

Status
Completed
Phase
Not Applicable
Locations
Morocco
Study Type
Interventional
Intervention
Decentralized GDM screening and initial management
Sponsored by
Institute of Tropical Medicine, Belgium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Gestational Diabetes Mellitus in Pregnancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Decentralized GDM screening and initial management

Standard GDM screening and management practice

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 22, 2016
Last Updated
February 28, 2018
Sponsor
Institute of Tropical Medicine, Belgium
Collaborators
Ecole Nationale de Santé Publique, Rabat, Morocco
search

1. Study Identification

Unique Protocol Identification Number
NCT02979756
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
November 14, 2016 (Actual)
Primary Completion Date
December 15, 2017 (Actual)
Study Completion Date
February 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Tropical Medicine, Belgium
Collaborators
Ecole Nationale de Santé Publique, Rabat, Morocco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus in Pregnancy

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Decentralized GDM screening and initial management
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard GDM screening and management practice
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Decentralized GDM screening and initial management
Intervention Description
Screening for GDM and initialization of nutritional therapy at the first level of care
Primary Outcome Measure Information:
Title
Macrosomia
Description
Difference in birth weight of babies of mothers detected with GDM in the different arms
Time Frame
within 6 months after being diagnosed with GDM
Secondary Outcome Measure Information:
Title
Acceptance of GDM screening
Description
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)
Time Frame
within 6 months after being diagnosed with GDM
Title
Lifestyle impact of GDM
Description
Assessing the impact of GDM screening and management on women's life (questionnaire/ Likert-scales)
Time Frame
within 6 months after being diagnosed with GDM

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bouchra Assarag, MD
Organizational Affiliation
Ecole Nationale de Santé Publique, Rabat, Morocco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bettina Utz, MD
Organizational Affiliation
Institute of Tropical Medicine, Antwerp, Belgium
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vincent De Brouwere, MD
Organizational Affiliation
Institute of Tropical Medicine, Antwerp, Belgium
Official's Role
Study Director
Facility Information:
Facility Name
20 facilities in Marrakech and Al Haouz - Region Marrakech-Safi
City
Marrakech
ZIP/Postal Code
40000
Country
Morocco

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32448233
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.
Results Reference
derived
PubMed Identifier
30592751
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.
Results Reference
derived
PubMed Identifier
28629468
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs