• About Us
    • Contact Us
    • Login
    • ObGFirst
  • COVID-19
  • Alerts
  • OB
  • 2T US Atlas
  • The Genome
  • GYN
    • GYN
    • Sexual Health
  • Primary Care
  • Your Practice
  • #GrandRounds
  • My Bookshelf
  • Now@ObG
  • Media
About Us Contact Us Login ObGFirst
  • COVID-19
  • Alerts
  • OB
  • 2T US Atlas
  • The Genome
  • GYN
    • 0 CME Hours
    • GYN
    • Sexual Health
  • Primary Care
  • Your Practice
  • #GrandRounds
  • My Bookshelf
  • Now@ObG
  • Media
#Grand Rounds

MiTy RCT Results: Is Metformin Use in Pregnancy Associated with Better Maternal and Neonatal Outcomes?

image_pdfFavoriteLoadingFavorite

BACKGROUND AND PURPOSE:

  • Feig et al. (The Lancet Diabetes & Endocrinology) investigated whether adding metformin to a standard regimen of insulin could improve neonatal outcomes in pregnant women with type 2 diabetes

METHODS:

  • Prospective, multicenter, randomized, parallel, double-masked, placebo-controlled trial
    • Metformin in Women with Type 2 Diabetes in Pregnancy (MiTy) Trial
  • Participants
    • Type 2 diabetes on insulin
    • Singleton pregnancy
    • Between 6w0d and 22w6d  
  • Intervention
    • Metformin + insulin
      • Metformin 1000 mg twice daily
    • Placebo + insulin
  • Study design
    • Randomized 1:1
    • Stratified by center and pre-pregnancy BMI (<30 kg/m2 or ≥30 kg/m2)
    • Fasting blood glucose levels obtained
      • Before the first meal of the day
      • Before the last meal of the day
      • 2 h after each meal
    • Insulin doses adjusted to hit the following glucose targets
      • Fasting glucose < 5.3 mmol/L (95 mg/dL)
      • 2-h postprandial glucose < 6.7 mmol/L (120 mg/dL)
    • Patients were seen every 1 to 4 weeks based on standard clinical care
  • Primary outcome
    • Composite of fetal and neonatal outcomes including ≥1 of the following: Pregnancy loss | Preterm birth (<37 weeks’ gestation) | Birth injury | Moderate or severe RDS | Neonatal hypoglycemia | NICU admission >24 hours
  • Secondary outcomes
    • Individual outcomes in the composite as well as other maternal and neonatal adverse outcomes

RESULTS:

  • Available with complete information for primary outcome
    • 233 in metformin group | 240 in placebo group

Primary Outcome

  • There was no significant difference in the primary composite neonatal outcome between the two groups (P = 0.86)
    • Metformin: 40%
    • Placebo: 40%
    • Relative risk (RR) 1.02 (95% CI, 0.83 to 1.26)

Secondary Outcomes

  • Women in metformin group achieved better glycemic control
    • Lower HbA1c at 34 weeks’ gestation (P=0.15)
      • Metformin: 5.90%
      • Placebo: 6.10%
    • Required less insulin (P<0.0001)
      • Metformin: 1.1 units per kg per day
      • Placebo: 1.5 units per kg per day
      • Difference −0.4 (95% CI, −0.5 to −0.2)
  • Women in the metformin group gained less weight (P<0.0001)
    • Metformin: 7.2 kg
    • Placebo: 9.0 kg
    • Difference −1.8 (95% CI, –2.7 to −0.9)
  • Women in the metformin group had fewer cesarean births (P=0.031)
    • Metformin: 53%
    • Placebo: 63%
    • RR 0.85 (95% CI, 0.73 to 0.99)
  • There were no significant differences in hypertensive disorders (P=0.93)
  • Compared with those in the placebo group, metformin-exposed infants
    • Weighed less (P=0.002)
      • Metformin: mean birthweight 3156 g
      • Placebo: 3375 g
      • Difference −218 (95% CI, –353 to −82)
    • Fewer were above the 97th centile for birthweight (P = 0.041)
      • Metformin: 9%
      • Placebo: 15%
      • RR 0.58 (95% CI, 0.34 to 0.97)
    • Fewer cases of macrosomia (P = 0.046)
      • Metformin: 12%
      • Placebo: 19%
      • RR 0.65 (95% CI, 0.43 to 0.99)
  • More infants in the metformin group were small for gestational age (P=0.026)
    • Metformin: 13%
    • Placebo: 7%
    •  RR 1.96 (95% CI, 1.10 to 3.64)

CONCLUSION:

  • There was no significant difference in the primary outcome (composite of serious neonatal outcomes) between pregnant women with type 2 diabetes on insulin who were treated with additional metformin vs placebo
  • Metformin for management of type 2 diabetes in pregnancy was associated with favorable maternal and neonatal outcomes such as
    • Improvements in maternal glycemic profile
    • Reduced neonatal adiposity
    • Reduced maternal weight gain
    • Lower insulin dosage required
    • Fewer cesareans
  • There were a larger number of small for gestational age infants in the metformin group
  • The authors conclude

Understanding the implications of these effects on infants will be important to properly advise patients who are contemplating the use of metformin during pregnancy

Learn More – Primary Sources:

Metformin in women with type 2 diabetes in pregnancy (MiTy): a multicentre, international, randomised, placebo-controlled trial

Now You Can Get ObG Clinical Research Summaries Direct to Your Phone, with ObGFirst

ObGFirst® – Try It Free! »

image_pdfFavoriteLoadingFavorite
< Previous
All #Grand Rounds Posts
Next >

Related ObG Topics:

Updated ACOG Guidance on Gestational Diabetes
ACOG Guidance on Perinatal Management of Pregestational Diabetes
Metformin in Pregnancy
EUROmediCAT Data: Does Metformin Use in the First Trimester of Pregnancy Increase the Risk for Congenital Anomalies?

Sections

  • COVID-19
  • Alerts
  • OB
  • GYN
    • GYN
    • Sexual Health
  • 2T US Atlas
  • The Genome
  • Primary Care
  • Your Practice
  • #Grand Rounds
  • My Bookshelf
  • Now@ObG
  • Media

ObG Library

  • Hysteroscopy
  • Fertility
  • Site Map/
  • © ObG Project/
  • Terms and Conditions/
  • Privacy/
  • Contact Us/
© ObG Project
SSL Certificate


  • Already an ObGFirst Member?
    Welcome back

    Log In

    Want to sign up?
    Get guideline notifications
    CME Included

    Sign Up

Get Guideline Alerts Direct to Your Phone
Try ObGFirst Free!

Sign In

Lost your password?

Sign Up for ObGFirst and Stay Ahead

  • - Professional guideline notifications
  • - Daily summary of a clinically relevant
    research paper
  • - Includes 1 hour of CME every month

ObGFirst Free Trial

Already a Member of ObGFirst®?

Please log in to ObGFirst to access the 2T US Atlas

Password Trouble?

Not an ObGFirst® Member Yet?

  • - Access 2T US Atlas
  • - Guideline notifications
  • - Daily research paper summaries
  • - And lots more!
ObGFirst Free Trial

Media - Internet

Computer System Requirements

OBG Project CME requires a modern web browser (Internet Explorer 10+, Mozilla Firefox, Apple Safari, Google Chrome, Microsoft Edge). Certain educational activities may require additional software to view multimedia, presentation, or printable versions of their content. These activities will be marked as such and will provide links to the required software. That software may be: Adobe Flash, Apple QuickTime, Adobe Acrobat, Microsoft PowerPoint, Windows Media Player, or Real Networks Real One Player.

Disclosure of Unlabeled Use

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

Jointly provided by

NOT ENOUGH CME HOURS

It appears you don't have enough CME Hours to take this Post-Test. Feel free to buy additional CME hours or upgrade your current CME subscription plan

Subscribe

JOIN OBGFIRST AND GET CME/CE CREDITS

One of the benefits of an ObGFirst subscription is the ability to earn CME/CE credits from the ObG entries you read. Tap the button to learn more about ObGFirst

Learn More
Leaving ObG Website

You are now leaving the ObG website and on your way to PRIORITY at UCSF, an independent website. Therefore, we are not responsible for the content or availability of this site