Prophylactic Metformin After Antenatal Corticosteroids

• Register: ISRCTN
• Last refreshed on: 24 October 2022
• Main ID: ISRCTN10156101
• Date of registration: 04/05/2017
• Prospective Registration: Yes
• Primary sponsor: University Malaya Medical Centre
• Public title: Prophylactic Metformin After Antenatal Corticosteroids
• Scientific title: Prophylactic Metformin After Antenatal Corticosteroids (PROMAC): A Double Blind Randomised Controlled Trial
• Date of first enrolment: 25/05/2017
• Target sample size: 60
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN10156101
• Study type: Interventional
• Study design: Double blind single-centre prospective randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Malaysia

Contacts

• Name: Jesrine Hong

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Pregnancy
Pregnancy and Childbirth
Pregnancy

Intervention(s)

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 will be approached to participate. Participants will be stratified to Gestational Diabetes Mellitus (GDM) and non-GDM pregnancies for separate randomisation using sequential assignment of sealed numbered envelopes which contained the study drug (a pack of six 500 mg metformin tablets or identical placebo).

Participants will be observed to take the first dose of their allocated study drug (500 mg metformin or identical placebo tablet) with the remaining five tablets to be taken twice daily with their breakfast and dinner over the following 3 days. If the second dose (at the next breakfast or dinner) is within 6 hours of the first dose, it should be omitted, with the second dose to be taken at the subsequent breakfast or dinner. If delivery occurs within the 3-day study period, the study drug will be stopped.

Point of care capillary blood glucose is to be tested at recruitment and repeated 6 times per day (before and 2 hours after each breakfast, lunch and dinner for up to three consecutive days (18 readings). If delivery occurs within the 3-day study period, the blood glucose monitoring will be stopped. Patients will be provided with blood glucose monitoring system (to be returned), test strips, lancets and taught to self-monitor their blood glucose level and record it in a record sheet. Participants will be told to continue their usual diet during the study.

The participants will be instructed that if blood glucose level is more than 11 mmol/L during monitoring, they are to contact investigator immediately thr

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

MREC ID NO: 20161019-4384

Source(s) of Monetary Support

University Malaya Medical Centre

Ethics review

Status:
Approval date:
Contact:

Medical Research Ethics Committee, University Malaya Medical Centre, 30/11/2016, ref: 20161019-4384

Results

• Results available: Yes
• Date Completed: 31/01/2018