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Completed

NCT Number: NCT04332393

Metformin to Treat Corticosteroids-induced Hyperglycemia

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.

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Key information

Conditions

Pregnancy Preterm Corticosteroids Induced Hyperglycemia Glycemic Control

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Baruch Padeh Medical center, Poriya, Tiberias, North, Israel

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

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 outcomes

  1. Mean maternal daily glucose values

    Time frame: Up to 4 days

    According to daily glucose charts

  2. 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 outcomes

  1. Mean maternal daily pre-prandial glucose values

    Time frame: Up to 4 days

    According to daily glucose charts

  2. Mean maternal daily post-prandial glucose values

    Time frame: Up to 4 days

    According to daily glucose charts

  3. Percent of abnormal values in the daily glucose chart

    Time frame: Up to 4 days

    According to daily glucose charts

  4. Rate of cesarean sections and operative deliveries

    Time frame: At delivery

  5. Rate of neonates who will be admitted to the neonatal intensive care unit

    Time frame: Up to a week after delivery

    APGAR scale of 0-worst and 10-best

  6. Apgar score at 1 and 5 minutes

    Time frame: At delivery

  7. Cord blood pH levels (when taken)

    Time frame: At delivery

  8. The rate of neonates with hyperbilirubinemia

    Time frame: Up to 7 days after delivery or discharge (which ever comes first)

  9. Neonatal mean head circumference

    Time frame: Up to 7 days after delivery or discharge (which ever comes first)

  10. Neonatal mean birth weight

    Time frame: at delivery

  11. The rate of fetal malformations and developmental disorders

    Time frame: Up to 7 days after delivery or discharge (which ever comes first)

  12. Mean and lowest neonatal blood glucose values in preterm neonates

    Time frame: Up to 7 days after delivery or discharge (which ever comes first)

  13. The rate of maternal adverse effects

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

The Baruch Padeh Medical Center, Poriya

Other Gov

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Apr 2, 2020
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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