Role of HbA1c in Predicting Adverse Pregnancy Outcomes

Recruiting

• Conditions: Gestational Diabetes

• Registration Number: NCT06676254
• Lead Sponsor: National University of Malaysia

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2024-06-27
• Study First Submitted: 2024-08-12
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-04
• Last Update Submitted: 2024-11-04
• Study First Posted: 2024-11-06
• Last Update Posted: 2024-11-06
• Primary Completion: 2026-06-26
• Study Completion: 2026-06-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 195

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the HbA1c reference value in predicting adverse pregnancy outcomes	Throughout study up to 1 year	c) To determine the HbA1c value to be used at each trimester in predicting adverse pregnancy outcomes

Secondary Outcome Measures

Name	Time	Method
To determine the prevalence of adverse pregnancy outcomes among women with GDM	Throughout study up to 1 year	Measurement of prevalent
To assess the HbA1c value during the diagnosis of GDM and its association with adverse pregnancy outcomes	Throughout study up to 1 year	Relationship between HbA1c and adverse pregnancy outcomes

Trial Locations

Locations (1)

Department of Obstetrics & Gynaecology, Hospital Canselor Tuanku Muhriz; 🇲🇾 Cheras, Wilayah Persekutuan Kuala Lumpur, Malaysia