Role of HbA1c in Predicting Adverse Pregnancy Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

195 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-27

Study Completion Date

2026-06-26

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gestational Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No