NL7799.

Study name	MYPP‐trial: Myo‐inositol Supplementation to Prevent Pregnancy Complications in Women with Polycystic Ovary Syndrome: a multi‐centre double‐blind randomised controlled trial
Methods	Study type: multi‐centre double‐blind randomised controlled trial
Participants	Inclusion criteria: women ≥ 18 years old with a singleton viable pregnancy, confirmed PCOS according to the Rotterdam consensus criteria, and ability to start supplements between 8+0 and 16+0 weeks gestational age. Target sample size: 464 women
Interventions	Intervention: 4 g myo‐inositol in addition to folic acid supplement, divided over two daily sachets of sugary powder throughout pregnancy. Control: similar‐looking supplement sachets which contain the standard dose of folic acid without the added myo‐inositol supplement.
Outcomes	Primary outcome: composite outcome of either gestational diabetes mellitus, and or preeclampsia and or preterm birth
Starting date	17 June 2019
Contact information	Chryselle Frank Erasmus MC, University Medical Center Rotterdam c.frank@erasmusmc.nl
Notes	Study stop date: 17 June 2019

BMI: body mass index
GDM: gestational diabetes mellitus
OGTT: oral glucose tolerance test
PCOS: polycystic ovarian syndrome