Oral Concurrent Session 5 - Hypertension
Oral Concurrent Sessions
Anne W.T Van Der Wel, MD (she/her/hers)
Amsterdam UMC, location University of Amsterdam
Amsterdam, Noord-Holland, Netherlands
Rebekka Bout-Rebel, MSc
Erasmus University Medical Center, Zuid-Holland, Netherlands
Chryselle M.C. Frank, MD
St. Antonius Ziekenhuis, Utrecht, Netherlands
Ruben G. Duijnhoven, PhD
Amsterdam UMC, location University of Amsterdam
Amsterdam, Noord-Holland, Netherlands
Bo E. Van Bree, MD
Maastricht UMC+, Limburg, Netherlands
Olivier Valkenburg, MD, PhD
Maastricht UMC+, Limburg, Netherlands
Salwan Al-Nasiry, MD, PhD
Maastricht UMC+, Limburg, Netherlands
Robbert H.F. van Oppenraaij, MD, PhD
Maasstad Ziekenhuis, Zuid-Holland, Netherlands
Tatjana E. Vogelvang, MD, PhD
Het Diakonessenhuis, Utrecht, Netherlands
Michelle E.M.H Westerhuis, MD, PhD
Catharina Ziekenhuis, Noord-Brabant, Netherlands
Jan Peter de Bruin, MD, PhD
Jeroen Bosch Ziekenhuis, Noord-Brabant, Netherlands
Hedwig P. van de Nieuwenhof
Jeroen Bosch Ziekenhuis, Noord-Brabant, Netherlands
Susanne C.J.P. Gielen, MD, PhD
Franciscus, Zuid-Holland, Netherlands
Myrthe L. Bandell, MD
Albert Schweitzer ziekenhuis, Zuid-Holland, Netherlands
Mireille N. Bekker, MD, PhD
University Medical Center Utrecht, Utrecht, Netherlands
Maurice G.A.J. Wouters, MD, PhD
Amsterdam UMC, location University of Amsterdam
Amsterdam, Noord-Holland, Netherlands
Velja Mijatovic, MD, PhD
Amsterdam UMC, location University of Amsterdam
Amsterdam, Noord-Holland, Netherlands
Arie Franx, MD, PhD
Erasmus University Medical Center, Zuid-Holland, Netherlands
Cornelis B. Lambalk, MD, PhD
Amsterdam UMC, location University of Amsterdam
Amsterdam, Noord-Holland, Netherlands
Frank J.M. Broekmans, MD, PhD
University Medical Center Utrecht, Utrecht, Netherlands
Rebecca C. Painter, MD, PhD
Amsterdam UMC, location University of Amsterdam
Amsterdam, Noord-Holland, Netherlands
Bart C.J.M. Fauser, MD, PhD
University of Utrecht and University Medical Center Utrecht, Utrecht, Netherlands
Joop S.E. Laven, MD, PhD
Erasmus University Medical Center, Zuid-Holland, Netherlands
Bas B. van Rijn, MD, PhD (he/him/his)
Professor of Perinatal Health and Technology
Eindhoven University of Technology, Noord-Brabant, Netherlands
MYPP Investigator Group
Erasmus University Medical Center, Zuid-Holland, Netherlands
To assess whether daily myo-inositol supplementation reduces a composite of gestational diabetes mellitus, preeclampsia and/or preterm birth in pregnant persons with polycystic ovary syndrome.
Study Design:
In this double-blind, multicenter randomized placebo controlled trial, pregnant persons with polycystic ovary syndrome received daily supplementation of 4 grams of myo-inositol, or matching placebo, from between 8 and 16 weeks gestation until delivery. The primary outcome was a composite of gestational diabetes mellitus, preeclampsia or preterm birth. Key secondary outcomes included obstetric, maternal and neonatal outcomes. The analysis was performed according to the intention-to-treat principle.
Results:
A total of 464 individuals, recruited at 13 hospitals in the Netherlands, underwent randomization. Characteristics at baseline were similar between groups, except for a higher proportion of biochemical hyperandrogenism in the myo-inositol group (29.0% vs. 18.5% in the placebo group). Two-thirds (67.5%) of participants conceived after assisted reproductive technology. The primary outcome occurred in 56 out of 224 participants (25.0%) in the myo-inositol group and in 61 out of 228 participants (26.8%) in the placebo group (relative risk, 0.93; 95% confidence interval, 0.68 to 1.28; P=0.67). No substantial between-group differences were observed for secondary outcomes, except for a higher incidence of primary caesarean section in the placebo group (11.6%, versus 5.9% in the myo-inositol group; relative risk 0.51; 95% confidence interval 0.27 to 0.97; P< 0.05). In the preplanned sub group analysis, no interactions were observed for participants with biochemical hyperandrogenism or obesity.
Conclusion:
Myo-inositol supplementation in pregnant individuals with polycystic ovary syndrome does not appear to lower the incidence of a composite outcome of gestational diabetes mellitus, preeclampsia or preterm birth compared with placebo. (Funded by The Netherlands Organisation for Health Research and Development [project number 848016013]; Research with human participants [CCMO] ID NL67329.078.18)
