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Metformin to Treat Corticosteroids-induced Hyperglycemia

Primary Purpose

Pregnancy Preterm, Glycemic Control, Corticosteroids Induced Hyperglycemia

Status
Recruiting
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Metformin
Sponsored by
The Baruch Padeh Medical Center, Poriya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy Preterm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Baruch Padeh Medical center, PoriyaRecruiting
  • Emek medical centerRecruiting
  • Galilee medical center
  • Ziv medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

metformin group

No treatment group

Arm Description

Outcomes

Primary Outcome Measures

Mean maternal daily glucose values
According to daily glucose charts
The rate of neonatal hypoglycemia in preterm deliveries (<37 gestational weeks)

Secondary Outcome Measures

Mean maternal daily pre-prandial glucose values
According to daily glucose charts
Mean maternal daily post-prandial glucose values
According to daily glucose charts
Percent of abnormal values in the daily glucose chart
According to daily glucose charts
Rate of cesarean sections and operative deliveries
Rate of neonates who will be admitted to the neonatal intensive care unit
APGAR scale of 0-worst and 10-best
Apgar score at 1 and 5 minutes
Cord blood pH levels (when taken)
The rate of neonates with hyperbilirubinemia
Neonatal mean head circumference
Neonatal mean birth weight
The rate of fetal malformations and developmental disorders
Mean and lowest neonatal blood glucose values in preterm neonates
The rate of maternal adverse effects

Full Information

First Posted
March 29, 2020
Last Updated
November 3, 2022
Sponsor
The Baruch Padeh Medical Center, Poriya
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1. Study Identification

Unique Protocol Identification Number
NCT04332393
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2020 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Baruch Padeh Medical Center, Poriya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Preterm, Glycemic Control, Corticosteroids Induced Hyperglycemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
323 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
metformin group
Arm Type
Experimental
Arm Title
No treatment group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
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
Primary Outcome Measure Information:
Title
Mean maternal daily glucose values
Description
According to daily glucose charts
Time Frame
Up to 4 days
Title
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)
Secondary Outcome Measure Information:
Title
Mean maternal daily pre-prandial glucose values
Description
According to daily glucose charts
Time Frame
Up to 4 days
Title
Mean maternal daily post-prandial glucose values
Description
According to daily glucose charts
Time Frame
Up to 4 days
Title
Percent of abnormal values in the daily glucose chart
Description
According to daily glucose charts
Time Frame
Up to 4 days
Title
Rate of cesarean sections and operative deliveries
Time Frame
At delivery
Title
Rate of neonates who will be admitted to the neonatal intensive care unit
Description
APGAR scale of 0-worst and 10-best
Time Frame
Up to a week after delivery
Title
Apgar score at 1 and 5 minutes
Time Frame
At delivery
Title
Cord blood pH levels (when taken)
Time Frame
At delivery
Title
The rate of neonates with hyperbilirubinemia
Time Frame
Up to 7 days after delivery or discharge (which ever comes first)
Title
Neonatal mean head circumference
Time Frame
Up to 7 days after delivery or discharge (which ever comes first)
Title
Neonatal mean birth weight
Time Frame
at delivery
Title
The rate of fetal malformations and developmental disorders
Time Frame
Up to 7 days after delivery or discharge (which ever comes first)
Title
Mean and lowest neonatal blood glucose values in preterm neonates
Time Frame
Up to 7 days after delivery or discharge (which ever comes first)
Title
The rate of maternal adverse effects
Time Frame
48 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enav Yefet, MD/PhD
Phone
972-46652306
Email
enyefet@poria.health.gov.il
Facility Information:
Facility Name
Baruch Padeh Medical center, Poriya
City
Tiberias
State/Province
North
ZIP/Postal Code
15208
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enav Yefet, MD/PhD
Facility Name
Emek medical center
City
Afula
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zohar Nachum
First Name & Middle Initial & Last Name & Degree
Zohar Nachum
Facility Name
Galilee medical center
City
Nahariya
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maya Wolf
Facility Name
Ziv medical center
City
Safed
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Peleg
First Name & Middle Initial & Last Name & Degree
David Peleg

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be shared according to the local review board regulations

Learn more about this trial

Metformin to Treat Corticosteroids-induced Hyperglycemia

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