Understanding how HbA1c levels predict pregnancy complications in women with gestational diabetes
Official title: Role of HbA1c in Predicting Adverse Pregnancy Outcomes Among Gestational Diabetes Mellitus Women: a Retrospective Study
Run by National University of Malaysia · NCT06676254 · Data updated 2026-11-12
This study is trying to see if certain HbA1c levels can help predict complications during pregnancy for women with gestational diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Sex | Women only |
| Enrollment | 195 (estimated) |
| Sponsor | National University of Malaysia Academic / other |
| Locations | 1 site (Cheras, Kuala Lumpur) |
| Status | Recruiting |
| Started | June 27, 2024 |
| Main results expected | June 26, 2026 |
| Study ends | June 26, 2026 |
| Registry record updated | November 6, 2024 |
| Trial ID | NCT06676254 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant women with a confirmed diagnosis of gestational diabetes and a singleton pregnancy.
✕Probably not a fit
Patients with major fetal anomalies, severe anemia, autoimmune diseases, or pre-existing diabetes may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to establish reference values for HbA1c that can predict adverse pregnancy outcomes in women diagnosed with gestational diabetes mellitus (GDM). It involves collecting data on HbA1c and fructosamine levels during antenatal care and documenting various pregnancy outcomes, including complications and modes of delivery. The study follows the NICE guidelines for diagnosing GDM and seeks to fill a knowledge gap regarding optimal HbA1c levels for managing this patient population. By analyzing these relationships, the study hopes to improve care for women with GDM.
Why it matters
Potential benefit: If successful, this study could lead to better management strategies for pregnant women with gestational diabetes, potentially reducing adverse outcomes.
How similar studies have gone: While there have been studies examining HbA1c in relation to pregnancy outcomes, this specific approach to establishing reference values for GDM is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Department of Obstetrics & Gynaecology, Hospital Canselor Tuanku Muhriz
Cheras, Kuala Lumpur, Malaysia Recruiting
Study contacts
- Study coordinator: Rahana ARahman, MD
- Email: drrahana@ukm.edu.my
- Phone: +60391455964
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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We will follow pregnant women who used donated eggs and women who used their own eggs to see if pregnancies after oocyte donation lead to a higher risk of pre-eclampsia.
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Mobile-based obstetric monitoring for hypertension and diabetes during pregnancy
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.