PCOS polycystic ovary syndrome
Conditions
Interventions
Participants randomly allocated to the intervention group will receive 4 grams
myo-inositol added to their routinely recommended folic acid supplement,
divided over two daily sachets of sugary powde
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Inclusion criteria
Inclusion criteria: - >= 18 years of age - Diagnosis of PCOS according to the Rotterdam consensus criteria and confirmed by a gynaecologist - A viable singleton pregnancy confirmed by ultrasound - Being able to initiate the use of study supplements between 8+0 and 16+0 weeks gestational age - Ability to understand Dutch or English - Ability to provide written informed consent
Exclusion criteria
Exclusion criteria: - Diagnosis of pre-existent type-1 or 2 diabetes mellitus - Pre-existent renal failure, defined as an estimated glomerular filtration rate (eGFR) less than 50 ml/min/1.73m2 - Use of myo-inositol supplements, other insulin-mimetics, hypoglycaemic agents (e.g. metformin) and/or systemic steroids, that cannot be discontinued at the time of inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint will be the incidence of the composite outcome of either gestational diabetes mellitus, and/or preeclampsia and/or preterm birth (i.e. birth before 37 weeks gestational age). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will include indicators of maternal physical and mental well-being, maternal health-related quality of life, neonatal outcomes, breastfeeding practices and breastmilk composition. In addition, a full cost-effectiveness analysis will be performed. | — |
Countries
Netherlands
Outcome results
None listed