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NCT04523363 | NOT YET RECRUITING | Prediabetes; Complicating Pregnancy

Metformin Versus Standard of Care Treatment in Pregnant Women With Prediabetes
Sponsor:

Gianna Wilkie

Information provided by (Responsible Party):

Gianna Wilkie

Brief Summary:

The purpose of this study is to assess if metformin reduces adverse outcomes associated with prediabetes in pregnancy. Our hypothesis is that pregnant women with prediabetes who are treated with metformin will show a greater reduction in large for gestational age infants at birth compared to women treated with the standard of care.

Condition or disease

Prediabetes; Complicating Pregnancy

Intervention/treatment

Metformin

Phase

PHASE4

Detailed Description:

Women in pregnancy are routinely screened for diabetes in the first trimester and those who fall into the prediabetes category by hemoglobin A1c level of 5.7 to 6.4%, fasting plasma glucose of greater than or equal to 100 to 125, or oral glucose tolerance test of greater than or equal to 140 to less than 200 before 14 weeks gestation will be approached for consent in our randomized trial. Once consent is obtained, the subjects will be randomized 1:1 into two parallel groups, the metformin treatment group and the standard of care treatment group (routine prenatal care). A random number generator will allocate the participants to the study groups. Women taking metformin will continue twice daily dosing for the duration of their pregnancy after randomization. Those in the standard of care group will receive routine prenatal care. Both groups will undergo routine gestational diabetes testing by 28 weeks. Obstetric, maternal, and neonatal outcomes will then be assessed of both groups until the 6 week postpartum visit.

Study Type : INTERVENTIONAL
Estimated Enrollment : 240 participants
Masking : SINGLE
Masking Description : Those assessing the outcomes from the medical chart will be blinded to the randomization process and the assigned study arm. Patients, the primary investigator, and their care providers will be aware of their treatment status.
Primary Purpose : TREATMENT
Official Title : Metformin Versus Standard of Care Treatment in Pregnant Women With Prediabetes: A Randomized Trial
Actual Study Start Date : 2025-06-01
Estimated Primary Completion Date : 2026-06-30
Estimated Study Completion Date : 2026-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Pregnant women with hemoglobin A1c of 5.7 to 6.4%, fasting plasma glucose of greater than or equal to 100 to 125, or oral glucose tolerance test of greater than or equal to 140 to less than 200 before 14 weeks gestation
  • * Pregnancy and delivery care obtained at University of Massachusetts (UMass) Memorial Medical Center
  • * Patients able to provide written informed consent
Exclusion Criteria
  • * Pre-existing diabetes diagnosis as assessed at visit in the first trimester by history or by laboratory evaluation as listed above
  • * Presence of contra-indication to metformin (liver, renal, or heart failure) or sensitivity to metformin
  • * Participants who are under the age of 18
  • * Multiple Pregnancy
  • * Patients already taking metformin for other indications
  • * Fetal defect noted on early dating ultrasound
  • * Miscarriage before randomization
Metformin Versus Standard of Care Treatment in Pregnant Women With Prediabetes

Location Details

NCT04523363

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How to Participate

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Locations

Not yet recruiting

United States, Massachusetts

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States, 01605