MYPP-trial: Myo-inositol Supplementation to Prevent Pregnancy Complications in Women with Polycystic Ovary Syndrome: a multicentre double-blind randomised controlled trial
Completed
- Conditions
- PCOSpolycystic ovary syndrome100147011001851510010273
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 464
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint will be the incidence of the composite outcome of either<br /><br>gestational diabetes mellitus, and/or preeclampsia and/or preterm birth (i.e.<br /><br>birth before 37 weeks gestational age). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints will include indicators of maternal physical and mental<br /><br>well-being, maternal health-related quality of life, neonatal outcomes,<br /><br>breastfeeding practices and breastmilk composition. In addition, a full<br /><br>cost-effectiveness analysis will be performed. </p><br>