Metformin Use in the First Trimester of Pregnancy and Risk for Nonlive Birth and Congenital Malformations: Emulating a Target Trial Using Real-World Data.

ABSTRACT:

Background

Metformin is a first-line pharmacotherapy for type 2 diabetes, but there is limited evidence about its safety in early pregnancy.

Objective

To evaluate the teratogenicity of metformin use in the first trimester of pregnancy.

Design

In an observational cohort of pregnant women with pregestational type 2 diabetes receiving metformin monotherapy before the last menstrual period (LMP), a target trial with 2 treatment strategies was emulated: insulin monotherapy (discontinue metformin treatment and initiate insulin within 90 days of LMP) or insulin plus metformin (continue metformin and initiate insulin within 90 days of LMP).

Setting

U.S. Medicaid health care administration database (2000 to 2018).

Participants

12 489 pregnant women who met the el

SUBMITTER: Chiu YH 

PROVIDER: S-EPMC12617958 | biostudies-literature | 2024 Jul

REPOSITORIES: biostudies-literature