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Prophylactic Metformin After Antenatal Corticosteroids

Prophylactic Metformin After Antenatal Corticosteroids (PROMAC): A Double Blind Randomised Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10156101
Enrollment
60
Registered
2017-05-04
Start date
2017-05-25
Completion date
Unknown
Last updated
2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Pregnancy and Childbirth Pregnancy

Interventions

Eligible patients receiving or about to receive intramuscular dexamethasone 12 mg for 2 doses 12 hours apart as per our institution’s antenatal corticosteroid protocol to improve neonatal outcome wil

Sponsors

University Malaya Medical Centre
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. All antenatal cases between 24-38 weeks who are about to receive or within 6 hours of first dose of antenatal corticosteroids for improvement of neonatal outcome in anticipation of premature delivery 2. Age more than 18 years old 3. Singleton pregnancy

Exclusion criteria

Exclusion criteria: 1. Patients on hypoglycaemic agent 2. Pre-existing Type 1 or Type 2 diabetes mellitus 3. Baseline capillary blood glucose more than 11mmol/L (at recruitment) 4. Patients in active labour or may deliver within the next 24 hours after administration of antenatal corticosteroids 5. Evidence of chorioamnionitis or other maternal or fetal infection 6. Twin/ multiple pregnancies 7. Patients on terbutaline or other beta-mimetic agents 8. Diet restrictions in anticipation of Caesarean birth

Design outcomes

Primary

MeasureTime frame
Hyperglycemia episodes in the 24 hours following administration of antenatal corticosteroids. Hyperglycemia is defined as pre meal blood glucose level of more than 5.3 mmol/L and 2 hours post prandial/meal blood glucose of more than 6.7 mmol/L and these are measured by point of care capillary blood glucose monitoring system at 6 points (pre and post breakfast, lunch and dinner).

Secondary

MeasureTime frame
1. Neonatal outcome, as assessed by reviewing patient’s and baby’s notes after delivery: 1.1 Birth weight 1.2 Umbilical cord arterial blood pH at birth 1.3 Apgar score at 1st and 5th minute of life/ birth 1.4 Special care nursery/ neonatal intensive care unit admission during birth admission 2. Maternal outcome, as assessed by reviewing patient’s notes after delivery: 2.1 Mode of delivery 2.2 Estimated blood loss during delivery 3. Need for additional or unplanned hypoglycaemic agent (metformin or other) use. This is indicated by capillary blood glucose level more than 11 mmol/L during the monitoring 4. Hyperglycaemia episodes (hyperglycaemia as defined in primary outcome measure) up to 48 hours after administration of antenatal corticosteroids (if still undelivered) 5. Hyperglycaemia episodes (hyperglycaemia as defined in primary outcome measure) up to 72 hours after administration of antenatal corticosteroids (if still undelivered) 6. Hypoglycaemia episodes (hypoglycaemia is defined as capillary blood glucose level equal or less than 3.9 mmol/L) 7. Diarrhoea is recorded using a yes/no question during study period up to Day 3 or delivery 8. Vomiting is recorded using a yes/no question during study period up to Day 3 or delivery

Countries

Malaysia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 16, 2026