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Early Screening for Gestational Diabetes Mellitus in a Low Risk Population

ConditionsGestational Diabetes Mellitus (GDM)Glucose Intolerance During Pregnancy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-39
SponsorNational University Hospital, Singapore

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Known pre-existing type 1 or type 2 diabetes mellitus at recruitment

Taking systemic steroid medication or metformin

Participation in another intervention trial

Trial design

Design model

Parallel

Treatments tested in this trial

  • Early OGTT Results Revealed

    Diagnostic 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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Early OGTT Results RevealedExperimental treatment 1 intervention
Group B: Early OGTT Results ConcealedNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
At birth to one month postpartum

Secondary outcomes

1

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.

Time frame
Up to 49 weeks, from the estimated date of conception (based on menstrual and ultrasound scan data) up to 6 weeks postpartum
2

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.

Time frame
Up to 49 weeks, from the estimated date of conception (based on menstrual and ultrasound scan data) up to 6 weeks postpartum
3

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.

Time frame
At Birth
4

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.

Time frame
From Birth to 3 months post-delivery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National University Hospital, Singapore

Lead sponsor

National University of Singapore

Collaborator

Agency for Science, Technology and Research

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: