Early Screening for Gestational Diabetes Mellitus in a Low Risk Population

NCT06704035 | Not Yet Recruiting

• 1 other identifier: 2023/00970
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Gestational Diabetes Mellitus (GDM); Glucose Intolerance During Pregnancy

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

Outcome Measures

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.

  At birth to one month postpartum

Secondary Outcomes (11)

• Pre-eclampsia and hypertensive disorders of pregnancy

  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

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

• Birthweight

  At Birth

• Neonatal complications and treatments

  From Birth to 3 months post-delivery

• Maternal depression and anxiety symptoms

  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)

Study Arms (2)

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.

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.

Interventions

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.

Early OGTT Results Revealed

Eligibility Criteria

• Age: 21 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:
• ) 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National University of Singapore: collaborator
• Agency for Science, Technology and Research: collaborator

Study Sites (1)

National University Hospital

Singapore, 119228, Singapore

Location

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MeSH Terms

Conditions

Diabetes, Gestational; Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Gladys Woon, BSc

CONTACT

+65 6516 4134; gladys_woon@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: November 25, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: November 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)