Understanding how HbA1c levels predict pregnancy complications in women with gestational diabetes
Role of HbA1c in Predicting Adverse Pregnancy Outcomes Among Gestational Diabetes Mellitus Women: a Retrospective Study
National University of Malaysia · NCT06676254
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 |
|---|---|
| Enrollment | 195 (estimated) |
| Sex | Female |
| Sponsor | National University of Malaysia (other) |
| Locations | 1 site (Cheras, Kuala Lumpur) |
| Trial ID | NCT06676254 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women with a confirmed diagnosis of gestational diabetes and a singleton pregnancy.
Not a fit: Patients with major fetal anomalies, severe anemia, autoimmune diseases, or pre-existing diabetes may not benefit from this study.
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 performed: While there have been studies examining HbA1c in relation to pregnancy outcomes, this specific approach to establishing reference values for GDM is relatively novel.
Eligibility criteria
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 this trial is running
Cheras, Kuala Lumpur
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gestational Diabetes, HbA1c, Gestational diabetes, large for gestational age, shoulder dystocia, caesarean section