Antenatal corticosteroids, particularly, betamethasone is routinely administered to pregnant women at risk for preterm delivery to improve neonatal outcomes. Although antenatal betamethasone was shown to induce both maternal hyperglycemia and neonatal hypoglycemia, to date, there is insufficient data to establish whether treatment for maternal hyperglycemia, particularly, metformin, will decrease the risk for neonatal hypoglycemia, particularly of preterm neonates. In the present study the investigators will examine the effect of treatment with metformin on maternal glycemic control and hypoglycemia in preterm neonates following maternal betamethasone treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
187
Metformin tablets according to glycemic control. Initial dose: 425 mg before meals (breakfast, lunch and supper) and 1700 mg around 22:00. Modifications may take place according to glycemic control
Baruch Padeh Medical center, Poriya
Tiberias, North, Israel
Emek medical center
Afula, Israel
Galilee medical center
Nahariya, Israel
Ziv medical center
Safed, Israel
Mean maternal daily glucose values
According to daily glucose charts
Time frame: Up to 4 days
The rate of neonatal hypoglycemia in preterm deliveries (<37 gestational weeks)
Time frame: Up to 7 days after delivery or discharge (which ever comes first)
Mean maternal daily pre-prandial glucose values
According to daily glucose charts
Time frame: Up to 4 days
Mean maternal daily post-prandial glucose values
According to daily glucose charts
Time frame: Up to 4 days
Percent of abnormal values in the daily glucose chart
According to daily glucose charts
Time frame: Up to 4 days
Rate of cesarean sections and operative deliveries
Time frame: At delivery
Rate of neonates who will be admitted to the neonatal intensive care unit
APGAR scale of 0-worst and 10-best
Time frame: Up to a week after delivery
Apgar score at 1 and 5 minutes
Time frame: At delivery
Cord blood pH levels (when taken)
Time frame: At delivery
The rate of neonates with hyperbilirubinemia
Time frame: Up to 7 days after delivery or discharge (which ever comes first)
Neonatal mean head circumference
Time frame: Up to 7 days after delivery or discharge (which ever comes first)
Neonatal mean birth weight
Time frame: at delivery
The rate of fetal malformations and developmental disorders
Time frame: Up to 7 days after delivery or discharge (which ever comes first)
Mean and lowest neonatal blood glucose values in preterm neonates
Time frame: Up to 7 days after delivery or discharge (which ever comes first)
The rate of maternal adverse effects
Time frame: 48 hours
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