Women with mild gestational diabetes mellitus between 24-38 weeks receiving antenatal dexamethasone for improvement of neonatal outcome. Pregnancy and Childbirth mild gestational diabetes mellitus
Conditions
Interventions
Randomisation sequence is generated in blocks of 4 or 8 by an investigator using random.org by an investigator not involved in recruitment. Randomisation is effected by the opening of sealed numbered
duration of intervention 12 hours)
or
2. Four doses of 6 mg of dexamethasone administered intramuscularly 12 hours apart (cumulative dose 24 mg of dexamethasone
duration of intervention 36 hours)
Participants are followed up with self monitoring of blood glucose (SMBG) using a personal glucometer 6 times per day (before and 2 hours after brea
Sponsors
University Malaya
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. All antenatal cases with mild gestational diabetes mellitus between 24-38 weeks who are planned for antenatal dexamethasone for improvement of neonatal outcome. Gestational diabetes mellitus defined as 75 g oral glucose tolerance test (OGTT) of fasting blood glucose = 5.1 mmol/l or a 2 hours post prandial glucose = 7.8 mmol/l (American Diabetes Association 2016 guidelines). A "mild case of gestational diabetes" is defined as a patient adequately controlled glycaemic status without the for need oral hypoglycaemic agent or insulin. 2. Age more than 18 years old 3. Singleton pregnancy 4. Viable pregnancy
Exclusion criteria
Exclusion criteria: 1. Patients on hypoglycaemic agent or insulin 2. Pre-existing Type 1 or Type 2 diabetes mellitus 3. Baseline capillary blood glucose level more than 11mmol/L (at recruitment) 4. Patients in active labour or likely to deliver within the next 24 hours after administration of antenatal dexamethasone 5. Evidence of chorioamnionitis or other maternal or fetal infection 6. Patients on terbutaline or other beta-mimetic agents 7. Diet restricted in anticipation of imminent Caesarean birth
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of Hyperglycaemia episodes is measured using the self-monitoring of blood glucose (SMBG) pre and post main meals following administration of antenatal dexamethasone at six time points (first 24 hours). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hyperglycaemia episodes in the second 24 hours after administration of antenatal dexamethasone is measured using self-monitoring of blood glucose (SMBG) pre and post main meals following administration of antenatal dexamethasone at six time points (second 24 hours) 2. Hyperglycaemia episodes in the third 24 hours after administration of antenatal dexamethasone is measured using self-monitoring of blood glucose (SMBG) pre and post main meals following administration of antenatal dexamethasone at six time points (second 24 hours) 3. Need for hypoglycaemic agent (metformin or other) is extracted from hospital records 4. Neonatal outcomes are assessed by reviewing patient and baby notes after delivery including: 4.1. Birth weight 4.2. Umbilical cord arterial pH at birth 4.3. Apgar score at 1st and 5th minute of life/birth 4.4. Special care nursery/neonatal intensive care unit admission during birth admission 5. Maternal outcomes are assessed by reviewing patient’s notes after delivery including: 5.1. Mode of delivery 5.2. Estimated blood loss during delivery 6. Patient satisfaction score with allocated antenatal dexamethasone regimen is measured using a Visual Numerical Rating Scale (scored 0 to 10, higher score greater satisfaction) after the third day of SMBG or just after delivery if this occurs sooner | — |
Countries
Malaysia
Outcome results
None listed