Corticosteroids Induced Hyperglycemia, Glycemic Control, Pregnancy Preterm
Conditions
Brief summary
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.
Interventions
DRUGMetformin
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
Sponsors
The Baruch Padeh Medical Center, Poriya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pregnant women receiving betamethasone from 24 to 36.5 gestational weeks * Before or within 24 hours following the first dose of betamethasone * ≥18 years old
Exclusion criteria
* Women with pre-gestational and gestational diabetes mellitus (GDM) * Known allergic sensitivity to metformin * Known chronic heart failure * Known chronic renal failure * Refuse to participate * Refuse to perform glucose challenge test/glucose tolerance test later on
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean maternal daily glucose values | Up to 4 days | According to daily glucose charts |
| The rate of neonatal hypoglycemia in preterm deliveries (<37 gestational weeks) | Up to 7 days after delivery or discharge (which ever comes first) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of abnormal values in the daily glucose chart | Up to 4 days | According to daily glucose charts |
| Rate of cesarean sections and operative deliveries | At delivery | — |
| Rate of neonates who will be admitted to the neonatal intensive care unit | Up to a week after delivery | APGAR scale of 0-worst and 10-best |
| Apgar score at 1 and 5 minutes | At delivery | — |
| Cord blood pH levels (when taken) | At delivery | — |
| Mean maternal daily pre-prandial glucose values | Up to 4 days | According to daily glucose charts |
| Neonatal mean head circumference | Up to 7 days after delivery or discharge (which ever comes first) | — |
| Neonatal mean birth weight | at delivery | — |
| The rate of fetal malformations and developmental disorders | Up to 7 days after delivery or discharge (which ever comes first) | — |
| Mean and lowest neonatal blood glucose values in preterm neonates | Up to 7 days after delivery or discharge (which ever comes first) | — |
| The rate of maternal adverse effects | 48 hours | — |
| The rate of neonates with hyperbilirubinemia | Up to 7 days after delivery or discharge (which ever comes first) | — |
| Mean maternal daily post-prandial glucose values | Up to 4 days | According to daily glucose charts |
Countries
Israel
Outcome results
None listed