Role of HbA1c in Predicting Adverse Pregnancy Outcomes

NCT06676254 | Recruiting DMC

• 1 other identifier: JEP-2024-475
• Study Type: observational
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gestational Diabetes

Keywords

HbA1c; Gestational diabetes; large for gestational age; shoulder dystocia; caesarean section

Outcome Measures

Primary Outcomes (1)

• 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

  Throughout study up to 1 year

Secondary Outcomes (2)

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

  Throughout study up to 1 year

• To assess the HbA1c value during the diagnosis of GDM and its association with adverse pregnancy outcomes

  Throughout study up to 1 year

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Department of Obstetrics & Gynaecology, Hospital Canselor Tuanku Muhriz

Cheras, Kuala Lumpur, 56000, Malaysia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum levels of HbA1c and fructosamine

MeSH Terms

Conditions

Diabetes, Gestational; Shoulder Dystocia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Rahana ARahman, MD

CONTACT

+60391455964; drrahana@ukm.edu.my

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof Dr

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: November 6, 2024
• Study Start: June 27, 2024
• Primary Completion (Estimated): June 26, 2026
• Study Completion (Estimated): June 26, 2026
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)