Clinical trial NCT05524259: MYPP-trial: Myo-inositol Supplementation to Prevent Pregnancy Complications in Women With Polycystic Ovary Syndrome.
Official title: MYPP-trial: Myo-inositol Supplementation to Prevent Pregnancy Complications in Women With Polycystic Ovary Syndrome: a Multicentre Double-blind Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes Mellitus
Preeclampsia
Preterm Birth
Polycystic Ovary Syndrome
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2022-09-01
Enrollment: 464
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Polycystic Ovary Syndrome (PCOS) is the most common endocrine disorder in women of reproductive age. PCOS is a heterogeneous condition, characterised by metabolic disturbances, insulin resistance and hyperandrogenism. Pregnancies in women with PCOS have an increased risk of gestational diabetes mellitus, preeclampsia and preterm birth, and their offspring have an increased risk of aberrant birth weight and hospitalization. After pregnancy, PCOS is thought to have an impact on breastfeeding success and breastmilk composition.

Current strategies to improve pregnancy outcome among women with PCOS have not demonstrated significant risk reduction. Myo-inositol is a commonly used dietary supplement with a favourable effect on glucose metabolism and insulin sensitivity. Optimal intake of myo-inositol is associated with a decrease in glucose, lower insulin and lower testosterone levels in women with PCOS. Among women with PCOS-related disorders (e.g. in women with obesity), myo-inositol supplementation in pregnancy has been shown to have clinical benefits in preventing adverse pregnancy outcomes in a number of clinical trials, by reducing the risk of gestational diabetes mellitus, hypertensive complications and preterm birth.

The MYPP-trial will be the first randomised prospective trial aimed specifically at pregnant women with PCOS, to evaluate the potential effectiveness of myo-inositol supplementation as a nutritional intervention to prevent all three pregnancy complications associated with PCOS (i.e. GDM, preeclampsia and preterm birth). Secondary objectives are to evaluate the impact of supplementation on maternal (mental) and neonatal health, breastfeeding practices and breastmilk composition. In addition, a full cost-effectiveness analysis will be performed.

Women with a diagnosis of PCOS and a singleton pregnancy between 8+0 and 16+0 weeks of gestational age are eligible. 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 powder throughout pregnancy. The control group will receive similar looking sachets of supplements containing only the standard dose of folic acid without the added myo-inositol supplement, as part of the current standard-of-care recommendation. In addition to receiving supplements, participants will be asked to complete three questionnaires, provide blood and urine samples once each trimester of pregnancy, and routine ultrasound scanning will be performed to assess fetal growth. All study visits will be aligned with routine antenatal care appointments. Additionally, subjects can choose to participate in research on the impact of myo-inositol supplementation on breastfeeding and take part in the MYPP biobank.

The results of this study will provide important novel recommendations for PCOS patients on the importance of optimising life-style and nutrient intake to improve pregnancy outcome.


Eligibility 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:

* 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

Primary outcomes:
measure: The incidence of PCOS patients in the two study arms that develop Gestational Diabetes Mellitus (GMD).
timeFrame: Measured from 12 weeks up to 28 weeks gestational age using an Oral Glucose Tolerance Test (OGTT)
measure: The incidence of PCOS patients in the two study arms that develop preeclampsia.
timeFrame: Measured from 20 weeks gestational age up to one week post-partum.
measure: The incidence of PCOS patients in the two study arm that give birth before 37 completed weeks of gestational age.
timeFrame: At delivery
Secondary outcomes:
measure: Maternal mental health assessed by Beck Depression Inventory (BDI) Scale II Netherlands.
timeFrame: Measured at study inclusion, 36 weeks of pregnancy and 6 weeks postpartum.
measure: Maternal Health Related Quality of Life assessed by 5-Level EuroQol - five dimension (EQ-5D-5L) and Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ)
timeFrame: Measured at study inclusion, 36 weeks of pregnancy and 6 weeks postpartum.
measure: The incidence of neonatal outcomes in the two study arms (e.g. incidence of neonatal intensive care unit (NICU) admissions, incidence of Neonatal hypoglycaemia).
timeFrame: Measured form birth and ultimately scored up until six weeks postpartum.
Other outcomes:
measure: Cost-effectiveness of myo-inositol supplementation using Health Technology Assessment (HTA) analyses.
timeFrame: Measured from study inclusion up until 6 weeks postpartum.
measure: Cost-effectiveness of myo-inositol supplementation using Health Technology Assessment (HTA) analyses.
timeFrame: Measured from study inclusion up until 6 weeks postpartum.
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
state: South-Holland
Study officials:
References: