Gestational DiabetesBEDIP-NNCT02036619
The Belgian Diabetes in Pregnancy Study: BEDIP-N Study
An observational study of Gestational Diabetes and Diabetes, run by Universitaire Ziekenhuizen KU Leuven at 7 sites in Belgium.
Trial summary
The General hypothesis is that the IADPSG screening strategy for gestational diabetes (GDM) will lead to an important increase in the work load and the prevalence of GDM in Belgium but that this might not be cost effective concerning the prevention of adverse pregnancy outcomes. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes, Diabetes
- How many people
- 2,006 participants
- Where
- 7 sitesBelgium
- Study dates
- Apr 2014to Jan 2018
- Phase
- Observational
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women without known diabetes attending a first prenatal visit in obsetrical centers, both in university and in non-university hospitals
Who may be able to join
- Women between 18-45 years,
- singleton pregnancy
- between 6-13 weeks of pregnancy
- the delivery has to be planned in the hospital where the study is performed.
Who cannot join
- < 18 years or > 45 year
- multiple pregnancy
- known diabetes or taking metformin
- chronic treatment with corticoids
- signs of a miscarriage
- Chronic medical condition: uncontrolled hypertension, severe heart disease, severe chronic liver disease, severe chronic kidney disease, chronic infection (such as HIV or hepatitis)
Show all 10Show fewer
- bariatric surgery
- delivery is planned in another center than the screening
- a normal follow up and treatment during pregnancy will not be possible (due to incompliance, psychiatric problems, severe communication problems…)
- participating in another study with any medication or intervention ( including life style intervention) up to 90 days before the start of the study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Belgium7 sites
OLV Aalst
Aalst, 9300
UZA
Antwerp, 2560
OLV Aalst-site Asse
Asse, 1730
Imelda Bonheiden
Bonheiden, 2820
AZ St Jan
Bruges, 8000
Kliniek St Jan Brussel
Brussels, 1000
UZ Leuven
Leuven, 3000
About this study
Official title: Prospective and Multi-centric Study on Diabetes During Pregnancy in Belgium
The General hypothesis is that the IADPSG screening strategy for gestational diabetes (GDM) will lead to an important increase in the work load and the prevalence of GDM in Belgium but that this might not be cost effective concerning the prevention of adverse pregnancy outcomes. The risk to develop type 2 diabetes postpartum will probably be lower than for women diagnosed with the two-step screening strategy.
In this prospective multicentric cohort study, women will be universally screened for pregestational diabetes and GDM at the first prenatal visit during the first trimester by measuring the fasting plasma glucose. In the second trimester, women without diagnosis of diabetes or GDM in the first trimester, will be universally screened for GDM using the 50g glucose challenge test (GCT) and the 75g oral glucose tolerance test (OGTT) with the IADPSG criteria for GDM. Diagnosis of GDM will be based on the 75g OGTT.
Read the detailed description
Accurate data on the prevalence of gestational diabetes (GDM) are lacking in Belgium and the current practice for screening for GDM varies across different centers. The discrepancy in recommendations is due to the lack of data based on research in our population concerning the best screening strategy for pregestational diabetes in early pregnancy and the lack of data on the best screening strategy for GDM. A substantial number of centers in Belgium already use the IADPSG screening strategy although not always a an universal screening strategy or not always as an one-step screening strategy.
The General hypothesis is that the IADPSG screening strategy will lead to an important increase in the work load and the prevalence of GDM in Belgium but that this might not be cost effective concerning the prevention of adverse pregnancy outcomes. The risk to develop type 2 diabetes postpartum will probably be lower than for women diagnosed with the two-step screening strategy.
In this prospective cohort study, women will be universally screened for pregestational diabetes and GDM at the first prenatal visit during the first trimester by measuring the fasting plasma glucose. GDM will be defined as a fasting plasma glucose ≥100-125mg/dl. This will allow to identify the most important risk factors for the development of GDM.
In the second trimester, women will be universally screened for GDM using the 50g glucose challenge test (GCT) and the 75g oral glucose tolerance test (OGTT)with the IADPSG criteria for GDM. Compared to the IADPSG screening strategy used in normal routine, the 50g GCT will be an extra test specific for the study. Diagnosis of GDM will be based on the 75g OGTT. Participants and researchers will therefore be blinded for the result of the GCT. The results of the GCT test will be used at the end of the study for research purposes only. The use of a GCT as an universal screening tool in a two-step approach with the use of the 75g 2-hour OGTT with the IADPSG criteria only if the GCT is abnormal, is not yet validated and will be evaluated in the study, since this could be a practical solution. Differences in GDM prevalence and pregnancy outcomes will be analyzed using different diagnostic criteria based on the 75g OGTT: the Carpenter \& Coustan criteria, the IADPSG criteria, and threshold values if diagnostic criteria would be based on an odds ratio of 2.0. The evaluation of different screening strategies and different diagnostic criteria will allow to explore the most cost effective methods for identifying women at risk for adverse pregnancy outcomes and at high risk for the development of type 2 diabetes after pregnancy. By using a multivariable risk estimation model based on the most relevant clinical risk factors and biochemical measures for GDM in our own population, the aim is to develop a simple and cost effective screening algorithm.
This study will also allow to evaluate the best short-term follow up strategy postpartum for women with a previous history of GDM. Different screening tests will be used three months postpartum: a fasting plasma glucose, Hba1c and 75g OGTT.
- Conditions
- Gestational Diabetes, Diabetes
- Keywords
- gestational diabetes, pregestational diabetes, screening, diagnostic criteria, IADPSG
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pregnant women without known diabetes | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in GDM prevalence between the 2-step and 1-step IADPSG screening strategy
Evaluation of the difference in GDM prevalence between the 2-step (50 glucose challenge test followed by a 75g OGTT) and 1-step IADPSG (directly 75g OGTT) screening strategy.
Measured: 2 years
The difference in macrosomia rate between GDM and non-GDM groups according to the IADPSG criteria.
Measured: 2.5 years
The number of participants with obesity, a history of GDM, a history of prediabetes or a family history of diabetes in women with and without GDM
risk factors will be analyzed such as ethnicity, maternal age, maternal BMI, family history of diabetes, history of GDM, history of impaired glucose regulation and socio-economic factors
Measured: 2 years
The glucose tolerance status 3 months postpartum in women with recent GDM.
Evaluation of rate of diabetes and prediabetes 3 months postpartum in women with recent GDM.
Measured: 3 years
Secondary outcomes (7)
Differences in rate of large for gestational age baby's, pre-eclampsia and caesarean section between GDM and non-GDM groups according to different diagnostic criteria
evaluation according different diagnostic criteria used (IADPSG criteria, the Carpenter \& Coustan criteria and with the diagnostic criteria based on an odds ratio of 2.0)
Measured: 2.5 years
The sensitivity and the specificity of the 50g glucose challenge test as a universal screening tool in a two-step approach with the use of the 75g 2-hour OGTT
Evaluation of the value of the 50g glucose challenge test as a universal screening tool in a two-step approach with the use of the 75g 2-hour OGTT with the IADPSG criteria, with the use of the Carpenter \& Coustan criteria and with the diagnostic criteria based on an odds ratio of 2.0
Measured: 2.5 years
Prevalence of pregestational diabetes in early pregnancy
Prevalence of pregestational diabetes before 14 weeks of pregnancy
Measured: 2 years
The number of participants with dyslipidaemia and hypertension in women with and without GDM
BMI, lipid profile, blood pressure, adiponectin, leptin and Hs-CRP
Measured: 2.5 years
Percentage body fat and c-peptide on cord blood in the offspring at birth of mothers with diabetes/GDM and without diabetes/GDM.
birth weight, length, head circumference, skinfold thickness and c-peptide on cord blood
Measured: 3 years
The prevalence of MODY-2 in women with a fasting plasma glucose ≥92mg/dl in early and late pregnancy
Measured: 3 years
The prevalence of women with a fasting plasma glucose ≥ 92-99mg/dl in early pregnancy to have a normal 75g OGTT between 26-28 weeks of pregnancy.
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,006 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- The National Lottery, FWO clinical doctoral scholarship, Novo Nordisk A/S, Merck Sharp & Dohme LLC, Sanofi, AstraZeneca, Novartis
- Responsible party
- Sponsor
- Investigators
- Katrien Benhalima, MD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036619
- Sponsor's protocol ID
- BEDIP-N study
- Acronym
- BEDIP-N
- Status last verified
- Nov 2017
- First submitted
- 6 Jan 2014
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Beunen K, Van den Abbeele F, Van Crombrugge P, Verhaeghe J, Vandeginste S, Verlaenen H, Maes T, Dufraimont E, Roggen N, De Block C, Jacquemyn Y, Mekahli F, De Clippel K, Van den Bruel A, Loccufier A, Laenen A, Devlieger R, Mathieu C, Benhalima K. Fetal size monitoring in women with gestational diabetes and normal glucose tolerance. Acta Diabetol. 2025 Jan;62(1):35-48. doi: 10.1007/s00592-024-02330-0. Epub 2024 Jul 20.
PubMed 39031189Raets L, Vandewinkel M, Van Crombrugge P, Moyson C, Verhaeghe J, Vandeginste S, Verlaenen H, Vercammen C, Maes T, Dufraimont E, Roggen N, De Block C, Jacquemyn Y, Mekahli F, De Clippel K, Van Den Bruel A, Loccufier A, Laenen A, Devlieger R, Mathieu C, Benhalima K. Preference of Women for Gestational Diabetes Screening Method According to Tolerance of Tests and Population Characteristics. Front Endocrinol (Lausanne). 2021 Nov 8;12:781384. doi: 10.3389/fendo.2021.781384. eCollection 2021.
PubMed 34858350Minschart C, De Weerdt K, Elegeert A, Van Crombrugge P, Moyson C, Verhaeghe J, Vandeginste S, Verlaenen H, Vercammen C, Maes T, Dufraimont E, De Block C, Jacquemyn Y, Mekahli F, De Clippel K, Van Den Bruel A, Loccufier A, Laenen A, Devlieger R, Mathieu C, Benhalima K. Antenatal Depression and Risk of Gestational Diabetes, Adverse Pregnancy Outcomes, and Postpartum Quality of Life. J Clin Endocrinol Metab. 2021 Jul 13;106(8):e3110-e3124. doi: 10.1210/clinem/dgab156.
PubMed 33693709Benhalima K, Van Crombrugge P, Verhaeghe J, Vandeginste S, Verlaenen H, Vercammen C, Dufraimont E, De Block C, Jacquemyn Y, Mekahli F, De Clippel K, Devlieger R, Mathieu C. The Belgian Diabetes in Pregnancy Study (BEDIP-N), a multi-centric prospective cohort study on screening for diabetes in pregnancy and gestational diabetes: methodology and design. BMC Pregnancy Childbirth. 2014 Jul 11;14:226. doi: 10.1186/1471-2393-14-226.
PubMed 25015413
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective and Multi-centric Study on Diabetes During Pregnancy in Belgium
- ClinicalTrials.gov ID
- NCT02036619
- Acronym / sponsor ID
- BEDIP-N / BEDIP-N study
- Conditions
- Gestational Diabetes, Diabetes
- Keywords
- gestational diabetes, pregestational diabetes, screening, diagnostic criteria, IADPSG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,006 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- The National Lottery, FWO clinical doctoral scholarship, Novo Nordisk A/S, Merck Sharp & Dohme LLC, Sanofi, AstraZeneca, Novartis
- Study start
- Apr 2014
- Primary completion
- Mar 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 15 Jan 2014 (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.
The General hypothesis is that the IADPSG screening strategy for gestational diabetes (GDM) will lead to an important increase in the work load and the prevalence of GDM in Belgium but that this might not be cost effective concerning the prevention of adverse pregnancy outcomes. The risk to develop type 2 diabetes postpartum will probably be lower than for women diagnosed with the two-step screening strategy.
In this prospective multicentric cohort study, women will be universally screened for pregestational diabetes and GDM at the first prenatal visit during the first trimester by measuring the fasting plasma glucose. In the second trimester, women without diagnosis of diabetes or GDM in the first trimester, will be universally screened for GDM using the 50g glucose challenge test (GCT) and the 75g oral glucose tolerance test (OGTT) with the IADPSG criteria for GDM. Diagnosis of GDM will be based on the 75g OGTT.
Detailed description
Accurate data on the prevalence of gestational diabetes (GDM) are lacking in Belgium and the current practice for screening for GDM varies across different centers. The discrepancy in recommendations is due to the lack of data based on research in our population concerning the best screening strategy for pregestational diabetes in early pregnancy and the lack of data on the best screening strategy for GDM. A substantial number of centers in Belgium already use the IADPSG screening strategy although not always a an universal screening strategy or not always as an one-step screening strategy.
The General hypothesis is that the IADPSG screening strategy will lead to an important increase in the work load and the prevalence of GDM in Belgium but that this might not be cost effective concerning the prevention of adverse pregnancy outcomes. The risk to develop type 2 diabetes postpartum will probably be lower than for women diagnosed with the two-step screening strategy.
In this prospective cohort study, women will be universally screened for pregestational diabetes and GDM at the first prenatal visit during the first trimester by measuring the fasting plasma glucose. GDM will be defined as a fasting plasma glucose ≥100-125mg/dl. This will allow to identify the most important risk factors for the development of GDM.
In the second trimester, women will be universally screened for GDM using the 50g glucose challenge test (GCT) and the 75g oral glucose tolerance test (OGTT)with the IADPSG criteria for GDM. Compared to the IADPSG screening strategy used in normal routine, the 50g GCT will be an extra test specific for the study. Diagnosis of GDM will be based on the 75g OGTT. Participants and researchers will therefore be blinded for the result of the GCT. The results of the GCT test will be used at the end of the study for research purposes only. The use of a GCT as an universal screening tool in a two-step approach with the use of the 75g 2-hour OGTT with the IADPSG criteria only if the GCT is abnormal, is not yet validated and will be evaluated in the study, since this could be a practical solution. Differences in GDM prevalence and pregnancy outcomes will be analyzed using different diagnostic criteria based on the 75g OGTT: the Carpenter \& Coustan criteria, the IADPSG criteria, and threshold values if diagnostic criteria would be based on an odds ratio of 2.0. The evaluation of different screening strategies and different diagnostic criteria will allow to explore the most cost effective methods for identifying women at risk for adverse pregnancy outcomes and at high risk for the development of type 2 diabetes after pregnancy. By using a multivariable risk estimation model based on the most relevant clinical risk factors and biochemical measures for GDM in our own population, the aim is to develop a simple and cost effective screening algorithm.
This study will also allow to evaluate the best short-term follow up strategy postpartum for women with a previous history of GDM. Different screening tests will be used three months postpartum: a fasting plasma glucose, Hba1c and 75g OGTT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pregnant women without known diabetes | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women without known diabetes attending a first prenatal visit in obsetrical centers, both in university and in non-university hospitals
Key inclusion criteria (4 listed)
- Women between 18-45 years,
- singleton pregnancy
- between 6-13 weeks of pregnancy
- the delivery has to be planned in the hospital where the study is performed.
Key exclusion criteria (10 listed)
- < 18 years or > 45 year
- multiple pregnancy
- known diabetes or taking metformin
- chronic treatment with corticoids
- signs of a miscarriage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in GDM prevalence between the 2-step and 1-step IADPSG screening strategy
Time frame: 2 years
Evaluation of the difference in GDM prevalence between the 2-step (50 glucose challenge test followed by a 75g OGTT) and 1-step IADPSG (directly 75g OGTT) screening strategy.
The difference in macrosomia rate between GDM and non-GDM groups according to the IADPSG criteria.
Time frame: 2.5 years
The number of participants with obesity, a history of GDM, a history of prediabetes or a family history of diabetes in women with and without GDM
Time frame: 2 years
risk factors will be analyzed such as ethnicity, maternal age, maternal BMI, family history of diabetes, history of GDM, history of impaired glucose regulation and socio-economic factors
The glucose tolerance status 3 months postpartum in women with recent GDM.
Time frame: 3 years
Evaluation of rate of diabetes and prediabetes 3 months postpartum in women with recent GDM.
7 secondary outcomes
Differences in rate of large for gestational age baby's, pre-eclampsia and caesarean section between GDM and non-GDM groups according to different diagnostic criteria
Time frame: 2.5 years
The sensitivity and the specificity of the 50g glucose challenge test as a universal screening tool in a two-step approach with the use of the 75g 2-hour OGTT
Time frame: 2.5 years
Prevalence of pregestational diabetes in early pregnancy
Time frame: 2 years
The number of participants with dyslipidaemia and hypertension in women with and without GDM
Time frame: 2.5 years
Percentage body fat and c-peptide on cord blood in the offspring at birth of mothers with diabetes/GDM and without diabetes/GDM.
Time frame: 3 years
The prevalence of MODY-2 in women with a fasting plasma glucose ≥92mg/dl in early and late pregnancy
Time frame: 3 years
The prevalence of women with a fasting plasma glucose ≥ 92-99mg/dl in early pregnancy to have a normal 75g OGTT between 26-28 weeks of pregnancy.
Time frame: 2.5 years
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 11 May 2018.
- Derived from this study: PubMed 39031189Beunen K, Van den Abbeele F, Van Crombrugge P, Verhaeghe J, Vandeginste S, Verlaenen H, Maes T, Dufraimont E, Roggen N, De Block C, Jacquemyn Y, Mekahli F, De Clippel K, Van den Bruel A, Loccufier A, Laenen A, Devlieger R, Mathieu C, Benhalima K. Fetal size monitoring in women with gestational diabetes and normal glucose tolerance. Acta Diabetol. 2025 Jan;62(1):35-48. doi: 10.1007/s00592-024-02330-0. Epub 2024 Jul 20.
- Derived from this study: PubMed 34858350Raets L, Vandewinkel M, Van Crombrugge P, Moyson C, Verhaeghe J, Vandeginste S, Verlaenen H, Vercammen C, Maes T, Dufraimont E, Roggen N, De Block C, Jacquemyn Y, Mekahli F, De Clippel K, Van Den Bruel A, Loccufier A, Laenen A, Devlieger R, Mathieu C, Benhalima K. Preference of Women for Gestational Diabetes Screening Method According to Tolerance of Tests and Population Characteristics. Front Endocrinol (Lausanne). 2021 Nov 8;12:781384. doi: 10.3389/fendo.2021.781384. eCollection 2021.
- Derived from this study: PubMed 33693709Minschart C, De Weerdt K, Elegeert A, Van Crombrugge P, Moyson C, Verhaeghe J, Vandeginste S, Verlaenen H, Vercammen C, Maes T, Dufraimont E, De Block C, Jacquemyn Y, Mekahli F, De Clippel K, Van Den Bruel A, Loccufier A, Laenen A, Devlieger R, Mathieu C, Benhalima K. Antenatal Depression and Risk of Gestational Diabetes, Adverse Pregnancy Outcomes, and Postpartum Quality of Life. J Clin Endocrinol Metab. 2021 Jul 13;106(8):e3110-e3124. doi: 10.1210/clinem/dgab156.
- Derived from this study: PubMed 25015413Benhalima K, Van Crombrugge P, Verhaeghe J, Vandeginste S, Verlaenen H, Vercammen C, Dufraimont E, De Block C, Jacquemyn Y, Mekahli F, De Clippel K, Devlieger R, Mathieu C. The Belgian Diabetes in Pregnancy Study (BEDIP-N), a multi-centric prospective cohort study on screening for diabetes in pregnancy and gestational diabetes: methodology and design. BMC Pregnancy Childbirth. 2014 Jul 11;14:226. doi: 10.1186/1471-2393-14-226.
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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.
Katrien Benhalima, MD principal investigator
Universitaire Ziekenhuizen KU Leuven
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes and Diabetes, run by Universitaire Ziekenhuizen KU Leuven at 7 sites in Belgium.
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 4 inclusion and 10 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 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belgium. 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?
Difference in GDM prevalence between the 2-step and 1-step IADPSG screening strategy (time frame: 2 years). The study lists 4 primary outcomes in all. 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 NCT02036619, which also lists 4 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 11 May 2018.