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NCT Number: NCT06676254

Role of HbA1c in Predicting Adverse Pregnancy Outcomes

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.

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Dystocia Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Obstetric Labor Complications Pregnancy Complications Shoulder Dystocia Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Department of Obstetrics & Gynaecology, Hospital Canselor Tuanku Muhriz

Cheras, Kuala Lumpur, 56000, Malaysia

Location status: Recruiting

Location contact

Azmawati Mohd Nawi, MD

SUB_INVESTIGATOR

Norasyikin Abd Wahab, MD

SUB_INVESTIGATOR

Nurul Iftida Basri, MBChB

SUB_INVESTIGATOR

Rahana ARahman, MD

CONTACT

[email protected]

+60391455964 ext. 5964

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. To determine the HbA1c reference value in predicting adverse pregnancy outcomes

    Time frame: Throughout study up to 1 year

    c) To determine the HbA1c value to be used at each trimester in predicting adverse pregnancy outcomes

Secondary outcomes

  1. To determine the prevalence of adverse pregnancy outcomes among women with GDM

    Time frame: Throughout study up to 1 year

    Measurement of prevalent

  2. 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

    Relationship between HbA1c and adverse pregnancy outcomes

Study contacts

Contact information is provided by the study sponsor or research team.

Rahana ARahman, MD

CONTACT

[email protected]

+60391455964

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Registry information

Official study title

Role of HbA1c in Predicting Adverse Pregnancy Outcomes Among Gestational Diabetes Mellitus Women: a Retrospective Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 6, 2024
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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