Role of HbA1c in Predicting Adverse Pregnancy Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Gestational Diabetes. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Malaysia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Role of HbA1c in Predicting Adverse Pregnancy Outcomes Among Gestational Diabetes Mellitus Women: a Retrospective Study
Overview
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.
Primary outcome measures
- To determine the HbA1c reference value in predicting adverse pregnancy outcomes [Time frame: Throughout study up to 1 year]
Secondary outcome measures (2)
- To determine the prevalence of adverse pregnancy outcomes among women with GDM [Time frame: Throughout study up to 1 year]
- To assess the HbA1c value during the diagnosis of GDM and its association with adverse pregnancy outcomes [Time frame: Throughout study up to 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Malaysia · 1 center
- Department of Obstetrics & Gynaecology, Hospital Canselor Tuanku Muhriz — Cheras
Identifiers
NCT: NCT06676254 · JEP-2024-475