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Prediabetes; Complicating PregnancyPhase 4NCT04523363

Metformin Versus Standard of Care Treatment in Pregnant Women With Prediabetes

A Phase 4 study testing Metformin in people with Prediabetes; Complicating Pregnancy, run by Gianna Wilkie at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Prediabetes; Complicating Pregnancy
What is being tested?
Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Jun 2025to 30 Jun 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: Metformin Versus Standard of Care Treatment in Pregnant Women With Prediabetes: A Randomized Trial

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.

Read the 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.

Being tested
Metformin
Keywords
maternal outcomes, neonatal outcomes, metformin, prediabetes, pregnancy
Medical subject headings
Prediabetic State, Pregnancy Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MetforminDrug

    Also called Glucophage

    Maximum dosage of 500 mg tablets 2 times a day (with each meal)

Study groups in NCT04523363
Study groupRoleWhat they receive
MetforminExperimentalStudy subjects will be randomized to the metformin medication arm. They will take a 500 mg tablet orally twice a day starting at 14 weeks of pregnancy until delivery.
Receives: Drug: Metformin
Standard of CareNo interventionStudy subjects will be randomized to standard of care and receive routine prenatal care without further intervention for their prediabetes.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Birth Weight

    Used to determine large for gestational age status

    Measured: At Birth

Secondary outcomes (20)

  1. Number of Participants needing Cesarean Section

    Number of Participants with Cesarean Section

    Measured: At Delivery

  2. Number of Participants with Postpartum Hemorrhage

    Estimated or quantitative blood loss greater than 1000 mL

    Measured: At Delivery

  3. Number of Participants with Development of Pregnancy Induced Hypertension

    Blood pressure, serum laboratory analysis, and urine protein would be assessed for diagnosis

    Measured: Through study completion, starting at 14 weeks until delivery

  4. Development of Gestational Diabetes

    A glucose tolerance test would be conducted at 28 weeks of pregnancy to diagnose diabetes

    Measured: Assessed at 28 weeks of pregnancy

  5. Maternal Weight Gain in Pregnancy

    Measured: At enrollment and last prenatal visit, starting at 14 weeks until delivery

  6. Pregnancy Outcome

    Number of Participants with Stillbirth, livebirth, pregnancy loss

    Measured: Through study completion, starting at 14 weeks until delivery

  7. Number of Participants with Preterm birth

    Less than 37 week delivery

    Measured: At delivery

  8. Neonatal Intensive Care Unit Admission

    Admission to level 2 or greater neonatal ICU and length of stay

    Measured: At delivery and within first 2 days of life

  9. Apgar Score at Birth

    <6 at 1 and 5 minutes

    Measured: At delivery

  10. Number of Participants with Neonatal Birth Trauma

    Brachial plexus injury

    Measured: At Delivery

  11. Number of Participants with Shoulder Dystocia

    Measured: At Delivery

  12. Number of Participants with Neonatal Hypoglycemia

    Measured: Within first 2 days of life

  13. Number of Participants with Neonatal Respiratory Distress

    Requiring 2 or more hours of respiratory support or oxygen with associated diagnosis

    Measured: At Delivery

  14. Number of Participants with Neonatal Hyperbilirubinemia

    Requiring phototherapy

    Measured: Within first 2 days of life

  15. Number of Participants requiring Neonatal Intubation

    Measured: At Delivery

  16. Neonatal Cooling

    Need for neonatal cooling within first 48 hours of life

    Measured: Within first 2 days of life

  17. Umbilical Cord Blood Level of C-peptide

    Measured: At Birth

  18. Umbilical Cord Blood Level of Leptin

    Measured: At Birth

  19. Umbilical Cord Blood Level of Insulin

    Measured: At Birth

  20. Placental Pathology

    Assessing for malperfusion pathology

    Measured: At Birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2020
  2. Study start1 Jun 2025 (estimated)
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Why it stopped: Study was not funded and could not be performed

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a prospective, single center, randomized study evaluating metformin in the treatment of pregnant women with prediabetes on maternal and neonatal outcomes.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04523363
Sponsor's protocol ID
H00021261
Status last verified
Apr 2025
First submitted
18 Aug 2020
Last updated
11 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Peterson C, Grosse SD, Li R, Sharma AJ, Razzaghi H, Herman WH, Gilboa SM. Preventable health and cost burden of adverse birth outcomes associated with pregestational diabetes in the United States. Am J Obstet Gynecol. 2015 Jan;212(1):74.e1-9. doi: 10.1016/j.ajog.2014.09.009. Epub 2014 Oct 28.

    PubMed 25439811

  • Lawrence JM, Contreras R, Chen W, Sacks DA. Trends in the prevalence of preexisting diabetes and gestational diabetes mellitus among a racially/ethnically diverse population of pregnant women, 1999-2005. Diabetes Care. 2008 May;31(5):899-904. doi: 10.2337/dc07-2345. Epub 2008 Jan 25.

    PubMed 18223030

  • Temple R, Murphy H. Type 2 diabetes in pregnancy - An increasing problem. Best Pract Res Clin Endocrinol Metab. 2010 Aug;24(4):591-603. doi: 10.1016/j.beem.2010.05.011.

    PubMed 20832738

  • Lee AM, Fermin CR, Filipp SL, Gurka MJ, DeBoer MD. Examining trends in prediabetes and its relationship with the metabolic syndrome in US adolescents, 1999-2014. Acta Diabetol. 2017 Apr;54(4):373-381. doi: 10.1007/s00592-016-0958-6. Epub 2017 Jan 9.

    PubMed 28070750

  • Chen L, Pocobelli G, Yu O, Shortreed SM, Osmundson SS, Fuller S, Wartko PD, Mcculloch D, Warwick S, Newton KM, Dublin S. Early Pregnancy Hemoglobin A1C and Pregnancy Outcomes: A Population-Based Study. Am J Perinatol. 2019 Aug;36(10):1045-1053. doi: 10.1055/s-0038-1675619. Epub 2018 Nov 30.

    PubMed 30500961

  • Professional Practice Committee for the Standards of Medical Care in Diabetes-2016. Diabetes Care. 2016 Jan;39 Suppl 1:S107-8. doi: 10.2337/dc16-S018. No abstract available.

    PubMed 26696673

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Metformin in people with Prediabetes; Complicating Pregnancy, run by Gianna Wilkie at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Birth Weight (time frame: At Birth). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04523363, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.

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