An observational study in Gestational Diabetes, sponsored by National University of Malaysia. Recruiting at 1 site in Malaysia. Open to female participants. Per ClinicalTrials.gov, last updated 2024-11-06.
Sponsored by National University of Malaysia · Observational
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.
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.
857 studies on the registry are indexed under Diabetes, Gestational; 199 are open to participants now.
This study's planned enrollment of 195 is close to the median of 198 across 274 observational studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →National University of Malaysia is the lead sponsor of 124 studies on the registry; 45 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Antenatal women attended antenatal clinics between January 2020-June 2024 in Hospital Canselor Tuanku Muhriz and diagnosed with GDM will be included in the study using purposive sampling method. Diagnosis of GDM is based on the Malaysia Diabetes CPG Guideline (fasting plasma glucose ≥5.1, 2 hours post-prandial ≥7.8).
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Exclusion Criteria:
To determine the HbA1c reference value in predicting adverse pregnancy outcomes
c) To determine the HbA1c value to be used at each trimester in predicting adverse pregnancy outcomes
Time frame: Throughout study up to 1 year
To determine the prevalence of adverse pregnancy outcomes among women with GDM
Measurement of prevalent
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
Relationship between HbA1c and adverse pregnancy outcomes
Time frame: Throughout study up to 1 year
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2024 (actual). Primary completion is estimated for Jun 2026, 23 months after the start.
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National University of Malaysia →