Clinical trial NCT06676254: Role of HbA1c in Predicting Adverse Pregnancy Outcomes
Official title: Role of HbA1c in Predicting Adverse Pregnancy Outcomes Among Gestational Diabetes Mellitus Women: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gestational Diabetes
Keywords: HbA1c
Gestational diabetes
large for gestational age
shoulder dystocia
caesarean section
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 195
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: To determine the HbA1c reference value in predicting adverse pregnancy outcomes
timeFrame: Throughout study up to 1 year
Secondary outcomes:
measure: To determine the prevalence of adverse pregnancy outcomes among women with GDM
timeFrame: Throughout study up to 1 year
measure: To assess the HbA1c value during the diagnosis of GDM and its association with adverse pregnancy outcomes
timeFrame: Throughout study up to 1 year
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: Department of Obstetrics & Gynaecology, Hospital Canselor Tuanku Muhriz
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
References: