Metformin and Gestational Diabetes in High-risk Patients: a RCTs
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Gestational diabetes mellitus (DM) is one of the most frequent complications in pregnant
patients with polycystic ovary syndrome (PCOS) in 20-40% of cases and ~40% of patients with
gestational DM are likely to have underlying polycystic ovarian morphology. A recent
meta-analysis demonstrated a significantly higher risk of developing gestational DM [odds
ratio (OR) 2.94; 95% confidence interval (CI): 1.70-5.08] in the PCOS population.
Metformin is an oral biguanide insulin sensitizer used for treating type-2 DM and recently
introduced to treat PCOS.
At the moment, preliminary data seem to reassure regarding the use of metformin in PCOS
patients showing benefits for maternal and fetal outcomes, without serious adverse events.
Furthermore, well-designed randomized, controlled trials (RCTs) on this issue are lacking,
thus it is not possible to either suggest or advice against the use of metformin during
pregnancy for reducing gestational DM risk. To this regard, PCOS represents an intriguing
model of "high-risk patients" to evaluate the efficacy of metformin for preventing DM
development.
The present protocol firstly will evaluate the effects of metformin administration in
reducing incidence of gestational DM in high-risk patients, such as pregnant PCOS patients.