Gestational Diabetes Mellitus in PregnancyNCT02979756
Improve Detection and Management of Gestational Diabetes Through the Primary Health Care Level in Morocco
A study testing Decentralized GDM screening and initial management in people with Gestational Diabetes Mellitus in Pregnancy, run by Institute of Tropical Medicine, Belgium at 1 site in Morocco.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- Decentralized GDM screening and initial management
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteMorocco
- Study dates
- 14 Nov 2016to 12 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women attending ANC (screening)
- Women diagnosed with GDM (follow-up)
- Informed consent
Who cannot join
- Pregnant women with pre-existing diabetes type 1 or 2
- No informed consent
Trial locations and contacts
1 site in 1 country.
Morocco1 site
20 facilities in Marrakech and Al Haouz - Region Marrakech-Safi
Marrakesh, 40000
About this study
Official title: Améliorer la Detection et la Prise en Charge du diabète Gestationnel au Niveau Des établissements de Soins de santé Primaires au Maroc
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.
- Being tested
- Decentralized GDM screening and initial management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decentralized GDM screening and initial managementProcedure or surgery
Screening for GDM and initialization of nutritional therapy at the first level of care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macrosomia
Difference in birth weight of babies of mothers detected with GDM in the different arms
Measured: within 6 months after being diagnosed with GDM
Secondary outcomes (2)
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)
Measured: within 6 months after being diagnosed with GDM
Lifestyle impact of GDM
Assessing the impact of GDM screening and management on women's life (questionnaire/ Likert-scales)
Measured: within 6 months after being diagnosed with GDM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study start14 Nov 2016
- Primary completion15 Dec 2017
- Study completion12 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- Ecole Nationale de Santé Publique, Rabat, Morocco
- Responsible party
- Sponsor
- Investigators
- Bouchra Assarag, MD, Principal investigator, Ecole Nationale de Santé Publique, Rabat, MoroccoBettina Utz, MD, Principal investigator, Institute of Tropical Medicine, Antwerp, BelgiumVincent De Brouwere, MD, Study director, Institute of Tropical Medicine, Antwerp, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979756
- Sponsor's protocol ID
- ITMBelgium
- Status last verified
- Feb 2018
- First submitted
- 22 Nov 2016
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 32448233Utz 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.
PubMed 30592751Utz 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.
PubMed 28629468
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Améliorer la Detection et la Prise en Charge du diabète Gestationnel au Niveau Des établissements de Soins de santé Primaires au Maroc
- ClinicalTrials.gov ID
- NCT02979756
- Acronym / sponsor ID
- ITMBelgium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- Ecole Nationale de Santé Publique, Rabat, Morocco
- Study start
- 14 Nov 2016 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 12 Feb 2018 (actual)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decentralized GDM screening and initial management | Experimental | Procedure: Decentralized GDM screening and initial managementIn 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women attending ANC (screening)
- Women diagnosed with GDM (follow-up)
- Informed consent
Key exclusion criteria (2 listed)
- Pregnant women with pre-existing diabetes type 1 or 2
- No informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decentralized GDM screening and initial managementScreening for GDM and initialization of nutritional therapy at the first level of care | Procedure or surgery | Decentralized GDM screening and initial management |
Primary outcome
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
2 secondary outcomes
Acceptance of GDM screening
Time frame: within 6 months after being diagnosed with GDM
Lifestyle impact of GDM
Time frame: within 6 months after being diagnosed with GDM
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Derived from this study: PubMed 32448233Utz 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.
- Derived from this study: PubMed 30592751Utz 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.
- Derived from this study: PubMed 28629468Utz 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bouchra Assarag, MD principal investigator
Ecole Nationale de Santé Publique, Rabat, Morocco
Bettina Utz, MD principal investigator
Institute of Tropical Medicine, Antwerp, Belgium
Vincent De Brouwere, MD study director
Institute of Tropical Medicine, Antwerp, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decentralized GDM screening and initial management in people with Gestational Diabetes Mellitus in Pregnancy, run by Institute of Tropical Medicine, Belgium at 1 site in Morocco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Morocco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macrosomia (time frame: within 6 months after being diagnosed with GDM). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02979756, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.