Clinical trial NCT04332393: Metformin to Treat Corticosteroids-induced Hyperglycemia
Official title: The Effect of Metformin in Pregnant Women Who Received Antenatal Corticosteroids on Glycemic Control and the Rate of Neonatal Hypoglycemia - Multicenter Prospective Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pregnancy Preterm
Glycemic Control
Corticosteroids Induced Hyperglycemia
Lead sponsor: The Baruch Padeh Medical Center, Poriya
Sponsor class: OTHER_GOV
First posted: 2020-04-02
Enrollment: 187
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean maternal daily glucose values
timeFrame: Up to 4 days
measure: The rate of neonatal hypoglycemia in preterm deliveries (<37 gestational weeks)
timeFrame: Up to 7 days after delivery or discharge (which ever comes first)
Secondary outcomes:
measure: Mean maternal daily pre-prandial glucose values
timeFrame: Up to 4 days
measure: Mean maternal daily post-prandial glucose values
timeFrame: Up to 4 days
measure: Percent of abnormal values in the daily glucose chart
timeFrame: Up to 4 days
measure: Rate of cesarean sections and operative deliveries
timeFrame: At delivery
measure: Rate of neonates who will be admitted to the neonatal intensive care unit
timeFrame: Up to a week after delivery
measure: Apgar score at 1 and 5 minutes
timeFrame: At delivery
measure: Cord blood pH levels (when taken)
timeFrame: At delivery
measure: The rate of neonates with hyperbilirubinemia
timeFrame: Up to 7 days after delivery or discharge (which ever comes first)
measure: Neonatal mean head circumference
timeFrame: Up to 7 days after delivery or discharge (which ever comes first)
measure: Neonatal mean birth weight
timeFrame: at delivery
measure: The rate of fetal malformations and developmental disorders
timeFrame: Up to 7 days after delivery or discharge (which ever comes first)
measure: Mean and lowest neonatal blood glucose values in preterm neonates
timeFrame: Up to 7 days after delivery or discharge (which ever comes first)
measure: The rate of maternal adverse effects
timeFrame: 48 hours
Other outcomes:
Locations:
city: Tiberias
country: Israel
facility: Baruch Padeh Medical center, Poriya
state: North
city: Afula
country: Israel
facility: Emek medical center
city: Nahariya
country: Israel
facility: Galilee medical center
city: Safed
country: Israel
facility: Ziv medical center
Study officials:
References: