MYPP-trial: Myo-inositol Supplementation to Prevent Pregnancy Complications in Women with Polycystic Ovary Syndrome: a multicentre double-blind randomised controlled trial

Recruiting

Conditions: Polycystic ovary syndrome, Polycysteus ovarium syndroom, PCOSPregnancy complications, zwangerschapscomplicaties

Registration Number: NL-OMON28285

Lead Sponsor: Erasmus MC, University Medical Center Rotterdam

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

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
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 Outcome Measures

Name	Time	Method
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.