Role of HbA1c in Predicting Adverse Pregnancy Outcomes

National University of Malaysia

Status: Enrolling

Conditions: Gestational Diabetes

Study type: Observational

Funder types: Other

Identifiers

NCT06676254

JEP-2024-475

Details and patient eligibility

About

This study aims to determine the reference value of HbA1c that can be used to predict adverse pregnancy outcomes. These adverse outcomes include LGA fetus, shoulder dystocia, caesarean section, pre-term birth, pre-eclampsia and fetal neonatal hypoglycaemia.

Full description

This study involves the data in our centre concerning women with gestational diabetes mellitus. The diagnosis of gestational diabetes mellitus is based on NICE guideline whereby the fasting glucose is 5.6 mol/l or more and 2 hours post glucose load 7.8 mol/l or more. The results of HbA1c and fructosamine taken during the antenatal care are documented. Outcomes of the pregnancy are documented such as antenatal complications, mode of delivery, gestational age at delivery, intrapartum and postpartum complications and neonatal complications. The results of this study is hoped to provide information on the optimum targeted levels of HbA1c and fructosamine for patients with gestational diabetes mellitus. This is the gap in knowledge in managing this cohort of patients.

Enrollment: 195 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant woman with singleton pregnancy
• Confirmed diagnosis of GDM based on Malaysia CPG (≥5.1/7.8)
• HbA1c level taken at least once at any time during the pregnancy
• Delivery after 28 weeks gestation

Exclusion criteria

• Major fetal anomaly
• Haemoglobin level of ≤9 g/dL (moderate or severe anaemia in pregnancy)
• Women with autoimmune diseases
• Overt diabetes or pre-existing diabetes