Gestational Diabetes Mellitus (GDM)EaGeRNCT06704035
Early Screening for Gestational Diabetes Mellitus in a Low Risk Population
A study testing Early OGTT Results Revealed in people with Gestational Diabetes Mellitus (GDM) and Glucose Intolerance During Pregnancy, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
This new feasibility pilot study aims to refine the design and protocols for a larger trial that will investigate the potential benefits of early oral glucose tolerance test (OGTT) screening in a population traditionally defined as low-risk for development of gestational diabetes. Read more about this study
- Who is it for?
- Ages 21 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM), Glucose Intolerance During Pregnancy
- What is being tested?
- Early OGTT Results Revealed
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Dec 2024to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women aged 21-39 years at recruitment
- Singleton pregnancy
- Less than 16 weeks pregnant at recruitment
- Intend to receive antenatal care and give birth at the National University Hospital
Who cannot join
- Known pre-existing type 1 or type 2 diabetes mellitus at recruitment
- Classified as high-risk for GDM at pregnancy booking using the traditional checklist:
- 2.1) Age ≥40 years 2.2) Overweight/obese, i.e., body mass index (BMI) ≥25.0 kg/m2 2.3) First degree relative with diabetes mellitus 2.4) Previously delivered a baby ≥4 kg 2.5) Previously diagnosed with GDM 2.6) Impaired glucose tolerance (IGT) or impaired fasting glycaemia (IFG) on previous testing 2.7) Polycystic ovarian syndrome (PCOS) 2.8) Poor obstetric history (e.g. recurrent pregnancy loss, previous intrauterine death, congenital malformations) 2.9) History of chronic hypertension, hyperlipidaemia or cardiovascular disease 2.10) Glycosuria ≥ 2+ on urine dipstick
- Taking systemic steroid medication or metformin
- Participation in another intervention trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site
National University Hospital
Singapore, 119228
Gladys Woon, BSc, +65 6516 4134, gladys_woon@nuhs.edu.sg
Shiao-Yng Chan, MBBChir (UK), FRCOG (UK), PhD
About this study
This new feasibility pilot study aims to refine the design and protocols for a larger trial that will investigate the potential benefits of early oral glucose tolerance test (OGTT) screening in a population traditionally defined as low-risk for development of gestational diabetes. The study will evaluate its potential effectiveness in reducing the risks of neonatal morbidity/mortality and obstetric complications. Additionally, a machine learning algorithm to predict gestational diabetes mellitus (GDM) risk based on routinely obtained clinical information at pregnancy booking, and minimally invasive methods, such as continuous glucose monitoring (CGM) and gingival crevicular fluid (GCF) sampling, are being explored to predict the risk of hyperglycaemia. This study aims to investigate the utility of early pregnancy screening to enable timely detection and management of early gestational diabetes development in a low-risk population, ultimately promoting better health outcomes for mothers and their babies.
Read the detailed description
The Early Screening for Gestational Diabetes Mellitus in a Low-Risk Population (EaGeR) pilot study aims to inform a future trial that would evaluate whether early oral glucose tolerance test (OGTT) screening can improve pregnancy and neonatal outcomes among low-risk pregnant women in Singapore, a country that has one of the highest global incidences of gestational diabetes mellitus (GDM). GDM is associated with higher risks of neonatal and obstetric complications in the short-term, and in the long-term increased cardiometabolic risks in both mothers and their children.
The current local GDM screening practice comprises universal screening of all pregnancies (without pre-existing diabetes) with an OGTT around 24-28 weeks' gestation, and only offering early pregnancy screening to women with traditional high-risk factors for GDM development. The issue is that around 70% of diagnosed GDM cases in Singapore do not possess traditional high-risk factors, and they could have been potentially picked up earlier in gestation, if screened. Conversely, many women identified as high-risk in early pregnancy show normal glucose concentrations in an OGTT when screened in early gestation and when re-screened at 24-28 weeks. This study builds on findings from previous trials, which showed that early screening and treatment of mild glucose intolerance in high-risk women can reduce neonatal complications. The EaGeR Trial seeks to determine whether similar benefits can be achieved in an apparently low-risk Asian population.
This pilot study will recruit 120 low-risk pregnant women before 16 weeks' gestation. All participants will undergo an early OGTT before 16 weeks' and be randomly assigned to one of two arms: the experimental arm, where early OGTT results are revealed and immediate follow-up actions taken if GDM is diagnosed using the WHO 2013 criteria, and the control arm, where early OGTT results are concealed, with follow-up in accordance with standard care involving the routine OGTT screen at 24-28 weeks' gestation.
Data will be collected from the medical records to evaluate the primary and secondary outcomes which include pregnancy and neonatal events, as well as infant measures. Additionally, maternal symptoms and biomarkers, infant anthropometry and breastfeeding will be evaluated. Outcomes will be compared between study arms.
Further, the study will also test the utility of a newly developed machine learning algorithm as a novel and non-invasive method which uses clinical factors available at pregnancy booking to assess individual risk for GDM development. It will also explore the utility of other minimally invasive methods of continuous glucose monitoring (CGM) and gingival crevicular fluid (GCF) sampling at an early stage of pregnancy, in predicting the risk of GDM development.
This initial pilot study will help to refine the design and protocols of the definitive EaGeR Trial which will eventually guide the development of the optimal screening strategy for GDM among low-risk pregnant women in Singapore for improved neonatal and obstetric outcomes.
- Being tested
- Early OGTT Results Revealed
- Keywords
- Early screening, Gestational diabetes, Oral glucose tolerance test (OGTT), Neonatal complications, Pregnancy complications, Machine learning algorithm, Continuous glucose monitoring (CGM), Gingival crevicular fluid (GCF), IADPSG criteria, WHO 2013 gestational diabetes criteria
- Medical subject headings
- Diabetes, Gestational, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early OGTT Results RevealedDiagnostic test
Early pregnancy screening with a three-time point (fasting, 1h, 2h) 75g oral glucose tolerance test before 16 weeks' gestation with plasma glucose results revealed to the patient and clinician for appropriate management of any diabetes (gestational and type 2, if diagnosed) from early pregnancy onwards.
| Study group | Role | What they receive |
|---|---|---|
| Early OGTT Results Revealed | Experimental | The results of the early OGTT conducted before 16 weeks' gestation will be revealed to the participants. If the results indicate gestational diabetes mellitus (GDM) by the WHO 2013 criteria, immediate follow-up actions, including appropriate treatments, will be taken. Those with a normal result will undertake the universally offered routine OGTT at 24-28 weeks' gestation. Receives: Diagnostic Test: Early OGTT Results Revealed |
| Early OGTT Results Concealed | No intervention | Participants in this arm will undergo an early oral glucose tolerance test (OGTT) before 16 weeks' gestation, however, the results will be concealed from the participants and study investigators, and results will not be acted upon (unless they are suggestive of pre-existing type 2 diabetes mellitus as reviewed by an independent clinician, in which case appropriate follow-up will be arranged). All participants (except those with results suggestive of type 2 diabetes) will undertake the routine OGTT at 24-28 weeks' gestation, as per standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of perinatal/neonatal morbidity/mortality
Display at least one of the following outcomes: preterm birth <37 weeks' gestation, large for gestational age neonate >90th centile of birthweight, birth trauma, shoulder dystocia, neonatal hypoglycaemia, neonatal respiratory distress, jaundice requiring phototherapy, stillbirth/neonatal death.
Measured: At birth to one month postpartum
Secondary outcomes (11)
Pre-eclampsia and hypertensive disorders of pregnancy
Number and proportion of participants who experience new onset hypertension in pregnancy, pre-eclampsia, eclampsia, or superimposed pre-eclampsia on chronic hypertension, with or without signs of progressive multi-system disorder or end-organ involvement, including cases of atypical pre-eclampsia where hypertension is not the predominant feature.
Measured: Up to 49 weeks, from the estimated date of conception (based on menstrual and ultrasound scan data) up to 6 weeks postpartum
Antenatal and Peripartum obstetric events
Number and proportion of participants who experience antenatal complications, undergo caesarean section, suffer perineal trauma, experience postpartum haemorrhage, or require other delivery interventions, including labour induction, extended labour duration, use of oxytocin, instrumental delivery, and high dependency care.
Measured: Up to 49 weeks, from the estimated date of conception (based on menstrual and ultrasound scan data) up to 6 weeks postpartum
Birthweight
Raw birthweight, macrosomia defined as birthweight >4000g, low birthweight <2500g, Large for Gestational Age (>90th centile) and Small for Gestational Age (<10th centile) using customised/standardised birthweight references.
Measured: At Birth
Neonatal complications and treatments
Admission to neonatal unit (including level of unit and length of stay), infant weight gain, hyperbilirubinaemia, infections, treatments (including antibiotics, iv/tube feeding, blood products, oxygen, breathing aids) and other neonatal conditions requiring medical care.
Measured: From Birth to 3 months post-delivery
Maternal depression and anxiety symptoms
Scores of maternal depression and anxiety symptoms on validated questionnaires (Edinburgh Postnatal Depression Scale and Generalized Anxiety Disorder-7 Scale). The scores on the Edinburgh Postnatal Depression Scale range from 0 to 30, with higher scores indicating more depression symptoms. The scores on the Generalized Anxiety Disorder-7 range from 0 to 21, where higher scores indicate more anxiety symptoms.
Measured: Before 16 weeks' gestation, at around 24-28 weeks gestation (accepted up to 32 weeks and 6 days), postpartum (~1 month; accept 3-6 weeks post-delivery)
Breastfeeding
Interviewer-administered questionnaire to evaluate the incidence and timing of skin-to-skin post-delivery, first suckle, duration of exclusivity of breastfeeding, and intake of formula feeds (timing of onset, duration, and frequency).
Measured: Postpartum (~1 month; accept 3-6 weeks post-delivery)
Prevalences of pre-existing diabetes mellitus and postpartum dysglycaemia (diabetes and pre-diabetes)
Pre-existing diabetes is identified based on glucose concentrations in a 75g OGTT defined by the World Health Organization (WHO) diagnostic criteria for non-pregnant adults. The following values are used to diagnose pre-existing diabetes: fasting glucose (0-hour): ≥ 7.0 mmol/L or 2-hour post-load glucose: ≥ 11.1 mmol/L. If either of these is met during the early pregnancy OGTT and post-partum OGTT (6-12 weeks post-delivery), the participant is diagnosed with pre-existing diabetes. Postpartum OGTT results will be obtained from medical records. Pre-diabetes postpartum will be identified by a 75g OGTT following the 2006 WHO criteria: Impaired fasting glucose (IFG) will be diagnosed when fasting plasma glucose (FPG) is between 6.1-6.9 mmol/L, while impaired glucose tolerance (IGT) will be defined by a 2-hour plasma glucose of 7.8-11.0 mmol/L.
Measured: Oral glucose tolerance test (OGTT) before 16 weeks of gestation and at around 6-12 weeks postpartum
Gestational diabetes incidence (early and late diagnosis)
GDM is diagnosed based on criteria set by the International Association of Diabetes and Pregnancy Study Groups (IADPSG) and WHO (2013). If at least one plasma glucose value meet the following criteria during a 75g three time point OGTT, it will indicate GDM: fasting glucose: ≥ 5.1 mmol/L, 1-hour post-load glucose: ≥ 10.0 mmol/L or 2-hour post-load glucose: ≥ 8.5 mmol/L.
Measured: Pregnancy Oral Glucose Tolerance Test (OGTT) before 16 weeks of gestation and/or at around 24-28 weeks of gestation (accept all results till 32 weeks and 6 days)
Predictive performance of a novel machine-learning-derived algorithm
A novel machine-learning-derived algorithm, specifically designed for the Singapore pregnant population, will use clinical data collected in early pregnancy (including maternal age, ethnicity, mean arterial blood pressure) to predict GDM development. The sensitivity, specificity, positive predictive and negative predictive value, receiver operating characteristic curve (ROC curve) will be evaluated for GDM and glucose intolerance as well as for pregnancy and neonatal outcomes.
Measured: Up to 54 weeks, from the estimated date of conception (based on menstrual and ultrasound scan data) up to the time of latest OGTT (32 weeks and 6 days gestation or OGTT at 6-12 weeks postpartum)
Continuous Glucose Monitor (CGM) Data Measurements and predictive performance
Identification of the key metrics from CGM evaluation that predict GDM, glucose intolerance, later pregnancy/postpartum dysglycaemia, and pregnancy and neonatal outcomes.
Measured: Up to 48 weeks, from recruitment up to the time of latest OGTT (32 weeks and 6 days gestation or OGTT at 6-12 weeks postpartum)
Gingival crevicular fluid (GCF) and circulating biomarkers
Identification of the key biomarkers from metabolomic, proteomic, and transcriptomic analyses on gingival crevicular fluid samples and blood obtained in early pregnancy that associate with GDM and glucose intolerance, later pregnancy/postpartum dysglycaemia, and pregnancy and neonatal outcomes.
Measured: Up to 48 weeks, from recruitment up to the time of latest OGTT (32 weeks and 6 days gestation or OGTT at 6-12 weeks postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Classic two parallel arm study in a 1:1 ratio. Participants will be assigned at random using a computerised database to either an experimental group (early "OGTT Results Revealed"), or a control group (early "OGTT Results Concealed"). The investigators, healthcare providers and participants will know which study arm they are allocated to, but the early OGTT results will only be made known for the "OGTT Results Revealed" group.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore, Agency for Science, Technology and Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704035
- Sponsor's protocol ID
- 2023/00970
- Other IDs
- 2023
- Acronym
- EaGeR
- Status last verified
- Sep 2024
- First submitted
- 17 Oct 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Teo E, Hassan N, Tam W, Koh S. Effectiveness of continuous glucose monitoring in maintaining glycaemic control among people with type 1 diabetes mellitus: a systematic review of randomised controlled trials and meta-analysis. Diabetologia. 2022 Apr;65(4):604-619. doi: 10.1007/s00125-021-05648-4. Epub 2022 Feb 9.
PubMed 35141761Majewska A, Stanirowski PJ, Wielgos M, Bomba-Opon D. Efficacy of Continuous Glucose Monitoring on Glycaemic Control in Pregnant Women with Gestational Diabetes Mellitus-A Systematic Review. J Clin Med. 2022 May 23;11(10):2932. doi: 10.3390/jcm11102932.
PubMed 35629058HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.
PubMed 18463375Li LJ, Huang L, Tobias DK, Zhang C. Gestational Diabetes Mellitus Among Asians - A Systematic Review From a Population Health Perspective. Front Endocrinol (Lausanne). 2022 Jun 16;13:840331. doi: 10.3389/fendo.2022.840331. eCollection 2022.
PubMed 35784581Simmons D, Hague WM, Teede HJ, Cheung NW, Hibbert EJ, Nolan CJ, Peek MJ, Girosi F, Cowell CT, Wong VW, Flack JR, McLean M, Dalal R, Robertson A, Rajagopal R. Hyperglycaemia in early pregnancy: the Treatment of Booking Gestational diabetes Mellitus (TOBOGM) study. A randomised controlled trial. Med J Aust. 2018 Nov 5;209(9):405-406. doi: 10.5694/mja17.01129. Epub 2018 May 28.
PubMed 29793404Vinter CA, Tanvig MH, Christensen MH, Ovesen PG, Jorgensen JS, Andersen MS, McIntyre HD, Jensen DM. Lifestyle Intervention in Danish Obese Pregnant Women With Early Gestational Diabetes Mellitus According to WHO 2013 Criteria Does Not Change Pregnancy Outcomes: Results From the LiP (Lifestyle in Pregnancy) Study. Diabetes Care. 2018 Oct;41(10):2079-2085. doi: 10.2337/dc18-0808. Epub 2018 Jul 30.
PubMed 30061318Harper LM, Jauk V, Longo S, Biggio JR, Szychowski JM, Tita AT. Early gestational diabetes screening in obese women: a randomized controlled trial. Am J Obstet Gynecol. 2020 May;222(5):495.e1-495.e8. doi: 10.1016/j.ajog.2019.12.021. Epub 2020 Jan 9.
PubMed 31926951Minschart C, Beunen K, Benhalima K. An Update on Screening Strategies for Gestational Diabetes Mellitus: A Narrative Review. Diabetes Metab Syndr Obes. 2021 Jul 5;14:3047-3076. doi: 10.2147/DMSO.S287121. eCollection 2021.
PubMed 34262311Logan KM, Emsley RJ, Jeffries S, Andrzejewska I, Hyde MJ, Gale C, Chappell K, Mandalia S, Santhakumaran S, Parkinson JR, Mills L, Modi N. Development of Early Adiposity in Infants of Mothers With Gestational Diabetes Mellitus. Diabetes Care. 2016 Jun;39(6):1045-51. doi: 10.2337/dc16-0030. Epub 2016 May 12.
PubMed 27208326Sovio U, Murphy HR, Smith GC. Accelerated Fetal Growth Prior to Diagnosis of Gestational Diabetes Mellitus: A Prospective Cohort Study of Nulliparous Women. Diabetes Care. 2016 Jun;39(6):982-7. doi: 10.2337/dc16-0160. Epub 2016 Apr 7.
PubMed 27208333Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS; Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med. 2005 Jun 16;352(24):2477-86. doi: 10.1056/NEJMoa042973. Epub 2005 Jun 12.
PubMed 15951574Chaparro A, Zuniga E, Varas-Godoy M, Albers D, Ramirez V, Hernandez M, Kusanovic JP, Acuna-Gallardo S, Rice G, Illanes SE. Periodontitis and placental growth factor in oral fluids are early pregnancy predictors of gestational diabetes mellitus. J Periodontol. 2018 Sep;89(9):1052-1060. doi: 10.1002/JPER.17-0497.
PubMed 29790168Abouzaid M, Howidi N, Badran Z, Mohammed G, Mousa NA. The potential role of the gingival crevicular fluid biomarkers in the prediction of pregnancy complications. Front Med (Lausanne). 2023 Jun 5;10:1168625. doi: 10.3389/fmed.2023.1168625. eCollection 2023.
PubMed 37342498Monteiro LJ, Varas-Godoy M, Monckeberg M, Realini O, Hernandez M, Rice G, Romero R, Saavedra JF, Illanes SE, Chaparro A. Oral extracellular vesicles in early pregnancy can identify patients at risk of developing gestational diabetes mellitus. PLoS One. 2019 Jun 26;14(6):e0218616. doi: 10.1371/journal.pone.0218616. eCollection 2019.
PubMed 31242249Ozcaka O, Ceyhan-Ozturk B, Gumus P, Akcali A, Nalbantsoy A, Buduneli N. Clinical periodontal status and inflammatory cytokines in gestational diabetes mellitus. Arch Oral Biol. 2016 Dec;72:87-91. doi: 10.1016/j.archoralbio.2016.08.012. Epub 2016 Aug 11.
PubMed 27552375
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Screening for Gestational Diabetes Mellitus in a Low Risk Population
- ClinicalTrials.gov ID
- NCT06704035
- Acronym / sponsor ID
- EaGeR / 2023/00970
- Keywords
- Early screening, Gestational diabetes, Oral glucose tolerance test (OGTT), Neonatal complications, Pregnancy complications, Machine learning algorithm, Continuous glucose monitoring (CGM), Gingival crevicular fluid (GCF)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National University of Singapore, Agency for Science, Technology and Research
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 25 Nov 2024 (actual)
- 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.
This new feasibility pilot study aims to refine the design and protocols for a larger trial that will investigate the potential benefits of early oral glucose tolerance test (OGTT) screening in a population traditionally defined as low-risk for development of gestational diabetes. The study will evaluate its potential effectiveness in reducing the risks of neonatal morbidity/mortality and obstetric complications. Additionally, a machine learning algorithm to predict gestational diabetes mellitus (GDM) risk based on routinely obtained clinical information at pregnancy booking, and minimally invasive methods, such as continuous glucose monitoring (CGM) and gingival crevicular fluid (GCF) sampling, are being explored to predict the risk of hyperglycaemia. This study aims to investigate the utility of early pregnancy screening to enable timely detection and management of early gestational diabetes development in a low-risk population, ultimately promoting better health outcomes for mothers and their babies.
Detailed description
The Early Screening for Gestational Diabetes Mellitus in a Low-Risk Population (EaGeR) pilot study aims to inform a future trial that would evaluate whether early oral glucose tolerance test (OGTT) screening can improve pregnancy and neonatal outcomes among low-risk pregnant women in Singapore, a country that has one of the highest global incidences of gestational diabetes mellitus (GDM). GDM is associated with higher risks of neonatal and obstetric complications in the short-term, and in the long-term increased cardiometabolic risks in both mothers and their children.
The current local GDM screening practice comprises universal screening of all pregnancies (without pre-existing diabetes) with an OGTT around 24-28 weeks' gestation, and only offering early pregnancy screening to women with traditional high-risk factors for GDM development. The issue is that around 70% of diagnosed GDM cases in Singapore do not possess traditional high-risk factors, and they could have been potentially picked up earlier in gestation, if screened. Conversely, many women identified as high-risk in early pregnancy show normal glucose concentrations in an OGTT when screened in early gestation and when re-screened at 24-28 weeks. This study builds on findings from previous trials, which showed that early screening and treatment of mild glucose intolerance in high-risk women can reduce neonatal complications. The EaGeR Trial seeks to determine whether similar benefits can be achieved in an apparently low-risk Asian population.
This pilot study will recruit 120 low-risk pregnant women before 16 weeks' gestation. All participants will undergo an early OGTT before 16 weeks' and be randomly assigned to one of two arms: the experimental arm, where early OGTT results are revealed and immediate follow-up actions taken if GDM is diagnosed using the WHO 2013 criteria, and the control arm, where early OGTT results are concealed, with follow-up in accordance with standard care involving the routine OGTT screen at 24-28 weeks' gestation.
Data will be collected from the medical records to evaluate the primary and secondary outcomes which include pregnancy and neonatal events, as well as infant measures. Additionally, maternal symptoms and biomarkers, infant anthropometry and breastfeeding will be evaluated. Outcomes will be compared between study arms.
Further, the study will also test the utility of a newly developed machine learning algorithm as a novel and non-invasive method which uses clinical factors available at pregnancy booking to assess individual risk for GDM development. It will also explore the utility of other minimally invasive methods of continuous glucose monitoring (CGM) and gingival crevicular fluid (GCF) sampling at an early stage of pregnancy, in predicting the risk of GDM development.
This initial pilot study will help to refine the design and protocols of the definitive EaGeR Trial which will eventually guide the development of the optimal screening strategy for GDM among low-risk pregnant women in Singapore for improved neonatal and obstetric outcomes.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Classic two parallel arm study in a 1:1 ratio. Participants will be assigned at random using a computerised database to either an experimental group (early "OGTT Results Revealed"), or a control group (early "OGTT Results Concealed"). The investigators, healthcare providers and participants will know which study arm they are allocated to, but the early OGTT results will only be made known for the "OGTT Results Revealed" group.
| Arm | Type | Receives |
|---|---|---|
| Early OGTT Results Revealed | Experimental | Diagnostic Test: Early OGTT Results RevealedThe results of the early OGTT conducted before 16 weeks' gestation will be revealed to the participants. If the results indicate gestational diabetes mellitus (GDM) by the WHO 2013 criteria, immediate follow-up actions, including appropriate treatments, will be taken. Those with a normal result will undertake the universally offered routine OGTT at 24-28 weeks' gestation. |
| Early OGTT Results Concealed | No intervention | –Participants in this arm will undergo an early oral glucose tolerance test (OGTT) before 16 weeks' gestation, however, the results will be concealed from the participants and study investigators, and results will not be acted upon (unless they are suggestive of pre-existing type 2 diabetes mellitus as reviewed by an independent clinician, in which case appropriate follow-up will be arranged). All participants (except those with results suggestive of type 2 diabetes) will undertake the routine OGTT at 24-28 weeks' gestation, as per standard care. |
Who may qualify
- Ages
- 21 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant women aged 21-39 years at recruitment
- Singleton pregnancy
- Less than 16 weeks pregnant at recruitment
- Intend to receive antenatal care and give birth at the National University Hospital
Key exclusion criteria (5 listed)
- Known pre-existing type 1 or type 2 diabetes mellitus at recruitment
- Classified as high-risk for GDM at pregnancy booking using the traditional checklist:
- 2.1) Age ≥40 years 2.2) Overweight/obese, i.e., body mass index (BMI) ≥25.0 kg/m2 2.3) First degree relative with diabetes mellitus 2.4) Previously delivered a baby ≥4 kg 2.5) Previously diagnosed with GDM 2.6) Impaired glucose tolerance (IGT) or impaired fasting glycaemia (IFG) on previous testing 2.7) Polycystic ovarian syndrome (PCOS) 2.8) Poor obstetric history (e.g. recurrent pregnancy loss, previous intrauterine death, congenital malformations) 2.9) History of chronic hypertension, hyperlipidaemia or cardiovascular disease 2.10) Glycosuria ≥ 2+ on urine dipstick
- Taking systemic steroid medication or metformin
- Participation in another intervention trial
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 |
|---|---|---|
| Early OGTT Results RevealedEarly pregnancy screening with a three-time point (fasting, 1h, 2h) 75g oral glucose tolerance test before 16 weeks' gestation with plasma glucose results revealed to the patient and clinician for appropriate management of any diabetes (gestational and type 2, if diagnosed) from early pregnancy onwards. | Diagnostic test | Early OGTT Results Revealed |
Primary outcome
Composite of perinatal/neonatal morbidity/mortality
Time frame: At birth to one month postpartum
Display at least one of the following outcomes: preterm birth <37 weeks' gestation, large for gestational age neonate >90th centile of birthweight, birth trauma, shoulder dystocia, neonatal hypoglycaemia, neonatal respiratory distress, jaundice requiring phototherapy, stillbirth/neonatal death.
11 secondary outcomes
Pre-eclampsia and hypertensive disorders of pregnancy
Time frame: Up to 49 weeks, from the estimated date of conception (based on menstrual and ultrasound scan data) up to 6 weeks postpartum
Antenatal and Peripartum obstetric events
Time frame: Up to 49 weeks, from the estimated date of conception (based on menstrual and ultrasound scan data) up to 6 weeks postpartum
Birthweight
Time frame: At Birth
Neonatal complications and treatments
Time frame: From Birth to 3 months post-delivery
Maternal depression and anxiety symptoms
Time frame: Before 16 weeks' gestation, at around 24-28 weeks gestation (accepted up to 32 weeks and 6 days), postpartum (~1 month; accept 3-6 weeks post-delivery)
Breastfeeding
Time frame: Postpartum (~1 month; accept 3-6 weeks post-delivery)
Prevalences of pre-existing diabetes mellitus and postpartum dysglycaemia (diabetes and pre-diabetes)
Time frame: Oral glucose tolerance test (OGTT) before 16 weeks of gestation and at around 6-12 weeks postpartum
Gestational diabetes incidence (early and late diagnosis)
Time frame: Pregnancy Oral Glucose Tolerance Test (OGTT) before 16 weeks of gestation and/or at around 24-28 weeks of gestation (accept all results till 32 weeks and 6 days)
Predictive performance of a novel machine-learning-derived algorithm
Time frame: Up to 54 weeks, from the estimated date of conception (based on menstrual and ultrasound scan data) up to the time of latest OGTT (32 weeks and 6 days gestation or OGTT at 6-12 weeks postpartum)
Continuous Glucose Monitor (CGM) Data Measurements and predictive performance
Time frame: Up to 48 weeks, from recruitment up to the time of latest OGTT (32 weeks and 6 days gestation or OGTT at 6-12 weeks postpartum)
Gingival crevicular fluid (GCF) and circulating biomarkers
Time frame: Up to 48 weeks, from recruitment up to the time of latest OGTT (32 weeks and 6 days gestation or OGTT at 6-12 weeks postpartum)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Background: PubMed 35141761Teo E, Hassan N, Tam W, Koh S. Effectiveness of continuous glucose monitoring in maintaining glycaemic control among people with type 1 diabetes mellitus: a systematic review of randomised controlled trials and meta-analysis. Diabetologia. 2022 Apr;65(4):604-619. doi: 10.1007/s00125-021-05648-4. Epub 2022 Feb 9.
- Background: PubMed 35629058Majewska A, Stanirowski PJ, Wielgos M, Bomba-Opon D. Efficacy of Continuous Glucose Monitoring on Glycaemic Control in Pregnant Women with Gestational Diabetes Mellitus-A Systematic Review. J Clin Med. 2022 May 23;11(10):2932. doi: 10.3390/jcm11102932.
- Background: PubMed 18463375HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.
- Background: PubMed 35784581Li LJ, Huang L, Tobias DK, Zhang C. Gestational Diabetes Mellitus Among Asians - A Systematic Review From a Population Health Perspective. Front Endocrinol (Lausanne). 2022 Jun 16;13:840331. doi: 10.3389/fendo.2022.840331. eCollection 2022.
- Background: PubMed 29793404Simmons D, Hague WM, Teede HJ, Cheung NW, Hibbert EJ, Nolan CJ, Peek MJ, Girosi F, Cowell CT, Wong VW, Flack JR, McLean M, Dalal R, Robertson A, Rajagopal R. Hyperglycaemia in early pregnancy: the Treatment of Booking Gestational diabetes Mellitus (TOBOGM) study. A randomised controlled trial. Med J Aust. 2018 Nov 5;209(9):405-406. doi: 10.5694/mja17.01129. Epub 2018 May 28.
- Background: PubMed 30061318Vinter CA, Tanvig MH, Christensen MH, Ovesen PG, Jorgensen JS, Andersen MS, McIntyre HD, Jensen DM. Lifestyle Intervention in Danish Obese Pregnant Women With Early Gestational Diabetes Mellitus According to WHO 2013 Criteria Does Not Change Pregnancy Outcomes: Results From the LiP (Lifestyle in Pregnancy) Study. Diabetes Care. 2018 Oct;41(10):2079-2085. doi: 10.2337/dc18-0808. Epub 2018 Jul 30.
- Background: PubMed 31926951Harper LM, Jauk V, Longo S, Biggio JR, Szychowski JM, Tita AT. Early gestational diabetes screening in obese women: a randomized controlled trial. Am J Obstet Gynecol. 2020 May;222(5):495.e1-495.e8. doi: 10.1016/j.ajog.2019.12.021. Epub 2020 Jan 9.
- Background: PubMed 34262311Minschart C, Beunen K, Benhalima K. An Update on Screening Strategies for Gestational Diabetes Mellitus: A Narrative Review. Diabetes Metab Syndr Obes. 2021 Jul 5;14:3047-3076. doi: 10.2147/DMSO.S287121. eCollection 2021.
- Background: PubMed 27208326Logan KM, Emsley RJ, Jeffries S, Andrzejewska I, Hyde MJ, Gale C, Chappell K, Mandalia S, Santhakumaran S, Parkinson JR, Mills L, Modi N. Development of Early Adiposity in Infants of Mothers With Gestational Diabetes Mellitus. Diabetes Care. 2016 Jun;39(6):1045-51. doi: 10.2337/dc16-0030. Epub 2016 May 12.
- Background: PubMed 27208333Sovio U, Murphy HR, Smith GC. Accelerated Fetal Growth Prior to Diagnosis of Gestational Diabetes Mellitus: A Prospective Cohort Study of Nulliparous Women. Diabetes Care. 2016 Jun;39(6):982-7. doi: 10.2337/dc16-0160. Epub 2016 Apr 7.
- Background: PubMed 15951574Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS; Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med. 2005 Jun 16;352(24):2477-86. doi: 10.1056/NEJMoa042973. Epub 2005 Jun 12.
- Background: PubMed 29790168Chaparro A, Zuniga E, Varas-Godoy M, Albers D, Ramirez V, Hernandez M, Kusanovic JP, Acuna-Gallardo S, Rice G, Illanes SE. Periodontitis and placental growth factor in oral fluids are early pregnancy predictors of gestational diabetes mellitus. J Periodontol. 2018 Sep;89(9):1052-1060. doi: 10.1002/JPER.17-0497.
- Individual participant dataSharing planned: No
Related trials for Gestational Diabetes Mellitus (GDM)
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early OGTT Results Revealed in people with Gestational Diabetes Mellitus (GDM) and Glucose Intolerance During Pregnancy, run by National University Hospital, Singapore at 1 site in Singapore.
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 5 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: opening soon, as of the sponsor's last update on 25 Nov 2024. 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 Singapore. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gladys Woon, BSc (+65 6516 4134, gladys_woon@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of perinatal/neonatal morbidity/mortality (time frame: At birth to one month postpartum). 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 NCT06704035, which also lists 31 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 25 Nov 2024.