INOVASIA Study: A Multicenter Randomized Clinical Trial of Pravastatin to Prevent Preeclampsia in High-Risk Patients

Muhammad Ilham Aldika Akbar; Muhammad Alamsyah Azis; Deviana Soraya Riu; Ellen Wawengkang; Ernawati Ernawati; Muhammad Adrianes Bachnas; Sri Sulistyowati; Erry Gumilar Dachlan; Johanes Cornelius Mose; Gus Dekker

doi:10.1055/a-1798-1925

American Journal of Perinatology, Inhaltsverzeichnis

Am J Perinatol 2024; 41(09): 1203-1211
DOI: 10.1055/a-1798-1925

Original Article

INOVASIA Study: A Multicenter Randomized Clinical Trial of Pravastatin to Prevent Preeclampsia in High-Risk Patients

Muhammad Ilham Aldika Akbar

¹Faculty of Medicine Universitas Airlangga, Department Obstetrics and Gynecology, Universitas Airlangga Hospital, Dr. Soetomo General Academic Hospital, Surabaya, Indonesia

,

Muhammad Alamsyah Azis

²Faculty of Medicine Universitas Padjajaran, Department Obstetrics and Gynecology, Dr. Hasan Sadikin General Hospital, Bandung, Indonesia

,

Deviana Soraya Riu

³Faculty of Medicine Universitas Hasanudin, Department Obstetrics and Gynecology, Dr. Wahidin Sudirohusodo General Hospital, Makassar, Indonesia

,

Ellen Wawengkang

³Faculty of Medicine Universitas Hasanudin, Department Obstetrics and Gynecology, Dr. Wahidin Sudirohusodo General Hospital, Makassar, Indonesia

,

Ernawati Ernawati

¹Faculty of Medicine Universitas Airlangga, Department Obstetrics and Gynecology, Universitas Airlangga Hospital, Dr. Soetomo General Academic Hospital, Surabaya, Indonesia

,

Muhammad Adrianes Bachnas

⁴Faculty of Medicine Universitas Sebelas Maret, Department Obstetrics and Gynecology, Dr. Moewardi General Hospital, Surakarta, Indonesia

,

Sri Sulistyowati

⁴Faculty of Medicine Universitas Sebelas Maret, Department Obstetrics and Gynecology, Dr. Moewardi General Hospital, Surakarta, Indonesia

,

Erry Gumilar Dachlan

¹Faculty of Medicine Universitas Airlangga, Department Obstetrics and Gynecology, Universitas Airlangga Hospital, Dr. Soetomo General Academic Hospital, Surabaya, Indonesia

,

Johanes Cornelius Mose

²Faculty of Medicine Universitas Padjajaran, Department Obstetrics and Gynecology, Dr. Hasan Sadikin General Hospital, Bandung, Indonesia

,

Gus Dekker

¹Faculty of Medicine Universitas Airlangga, Department Obstetrics and Gynecology, Universitas Airlangga Hospital, Dr. Soetomo General Academic Hospital, Surabaya, Indonesia

⁵Department Obstetrics and Gynecology, Lyell McEwin Hospital, The University of Adelaide, Adelaide, South Australia

› Institutsangaben

Abstract

Objective Our objective was to determine if treatment with pravastatin prevents preeclampsia in pregnant patients at risk of preeclampsia.

Materials and Methods The study was performed in four major tertiary hospitals in Surabaya, Bandung, and Makassar between 2017 and 2021. Pregnant women at high risk of developing preeclampsia were recruited and randomized into an intervention group and control group. The control group received low-dose aspirin (80 mg) and calcium (1 g) daily, while the intervention group received additional pravastatin (20 mg twice daily) starting from 14 to 20 weeks' gestation until delivery. The pregnancy was followed until delivery, and the clinical data were collected. The primary outcome was the occurrence of preeclampsia.

Result A total of 173 people participated in this study, including 86 in the control group and 87 in the pravastatin group. The pravastatin group had a significantly lower rate of preterm preeclampsia (13.8 vs. 26.7%; p = 0.034; odds ratio [OR] = 0.034, 95% confidence interval [CI] = 0.202–0.905) and preterm birth (16.1 vs. 36%; p = 0.003; OR = 0.340, 95% CI = 0.165–0.7), mostly indicated preterm birth. Preeclampsia occurred later in the pravastatin group than in the control group (36.39 + 2.32 vs. 34.89 + 3.38 weeks, p = 0.048). Overall, the pravastatin group showed better perinatal outcomes. Neonates with low Apgar scores (<7) at 1 minute (5.7 vs. 25.6%, p = 0.000) and 5 minutes (2.3 vs. 25.6%, p = 0.028) were significantly less common in the pravastatin group. Additionally, the rate of low birthweight babies (<2,500 g) was lower in the pravastatin group (27.6 vs. 40.7%; p = 0.069).

Conclusion Pravastatin (20 mg bid) significantly reduces the risk of preterm preeclampsia and preterm birth in women at a high risk of developing preeclampsia.

Key Points

This is an open-label multicenter RCT to evaluate pravastatin effect to prevent preeclampsia.
Pravastatin significantly reduces the risk of preterm preeclampsia (PE) and preterm birth in high risk PE women.
Pravastatin had a beneficial effect on perinatal outcomes, including Apgar scores and birth weight.

Keywords

preeclampsia - pravastatin - maternal outcomes - perinatal outcomes - short-term health

Volltext

Referenzen

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