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Trial Title:
MYPP-trial: Myo-inositol Supplementation to Prevent Pregnancy Complications in Women With Polycystic Ovary Syndrome.
NCT ID:
NCT05524259
Condition:
Gestational Diabetes Mellitus
Preeclampsia
Preterm Birth
Polycystic Ovary Syndrome
Conditions: Official terms:
Polycystic Ovary Syndrome
Diabetes, Gestational
Pre-Eclampsia
Premature Birth
Pregnancy Complications
Syndrome
Folic Acid
Vitamin B Complex
Inositol
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Myo-inositol and routinely recommended folic acid
Description:
Participants randomly allocated to the intervention group will receive 4 grams
myo-inositol added to their routinely recommended 0.4 mg folic acid supplement, divided
over two daily sachets of sugary powder throughout pregnancy.
Arm group label:
Myo-inositol and routinely recommended folic acid
Intervention type:
Dietary Supplement
Intervention name:
Routinely recommended folic acid
Description:
The control group will receive similar looking sachets of supplements containing only the
standard dose of 0.4 mg folic acid without the added myo-inositol supplement as part of
the current standard-of-care recommendation.
Arm group label:
Routinely recommended folic acid
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Erasmus University Medical Center
Address:
City:
Rotterdam
Zip:
3015 GD
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Rebekka Bout - Rebel, MSc
Phone:
31612437377
Email:
r.bout-rebel@erasmusmc.nl
Start date:
June 21, 2019
Completion date:
February 2024
Lead sponsor:
Agency:
Erasmus Medical Center
Agency class:
Other
Collaborator:
Agency:
ZonMw: The Netherlands Organisation for Health Research and Development
Agency class:
Other
Source:
Erasmus Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05524259
http://mypp-trial.nl/
