Clinical trial Recruiting at 1 site Observational Women only

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.

More Gestational Diabetes trials

Quick facts

Study typeObservational
SexWomen only
Enrollment195 (estimated)
SponsorNational University of Malaysia
Academic / other
Locations1 site (Cheras, Kuala Lumpur)
StatusRecruiting
StartedJune 27, 2024
Main results expectedJune 26, 2026
Study endsJune 26, 2026
Registry record updatedNovember 6, 2024
Trial IDNCT06676254 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

  • Department of Obstetrics & Gynaecology, Hospital Canselor Tuanku Muhriz
    Cheras, Kuala Lumpur, Malaysia
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.