Oral Metformin Versus Injectable Insulin for the Treatment of Gestational Diabetes

What is the Purpose of this Study?

Gestational diabetes mellitus (GDM) is one of the most widespread medical problems in pregnancy. The most common medication is insulin, which requires daily injections; another option is metformin, which is an oral pill. The purpose of this study is to determine whether metformin works as well as insulin to prevent pregnancy complications. Researchers also want to learn whether metformin is as safe as insulin for mothers and children (who were born to mothers who received treatment). Additionally, the study will examine the reasons (if any) why pregnant people with GDM prefer metformin versus insulin. Study procedures include completion of short surveys, blood sample collection, and medical records review (including how well the participant and newborn baby are doing during and after delivery).


Eligibility

  • * Singleton gestation. Twin reduction to singleton, either spontaneously or therapeutically, is eligible if it occurred before 14 weeks gestational age.
  • * Age 18 years or older
  • * Gestational age at randomization between 20 0/7 - 32 6/7 weeks based on project gestational age.
  • * GDM diagnosis less than or equal to 31 6/7 weeks based on project gestational age.
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

A Comparative Effectiveness Trial of Oral Metformin versus Injectable Insulin for the Treatment of Gestational Diabetes

Study Details
Disease Type/Condition

Other

Principal Investigator

Esakoff, Tania

Age Group

Adult

Phase

Not Available

IRB Number

STUDY00003624

ClinicalTrials.gov ID

NCT06445946

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Esakoff, Tania

Age Group

Adult

Phase

Not Available

IRB Number

2024H0193

ClinicalTrials.gov ID

NCT06445946

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org