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

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

Maternal serum levels of asymmetric dimethylarginine in normal and preeclamptic pregnancies.

The study aims to investigate maternal serum levels of asymmetric dimethylarginine (ADMA) in preeclampsia. Serum samples were collected from 57 women with preeclamptic pregnancies and 30 women with normal pregnancies during the third trimester. ADMA levels were measured with the ELISA method. ADMA levels in preeclamptic pregnancies were significantly higher when compared with normal pregnancies (2.35 ± 3.20 nmol/l versus 0.35 ± 0.10 nmol/l; p < .05). ADMA levels show a significant positive correlation with systolic and diastolic pressure, urea, and creatinine but a negative correlation with proteinuria. ADMA levels have a significant strong correlation with PE. ADMA levels are significantly higher in preeclamptic pregnancy compared with normal pregnancy.

Factors associated with and mode of delivery in prelabour rupture of membrane at secondary health care.

OBJECTIVE: The study aimed to explore factors associated with prelabor rupture of membrane (PROM) and mode of delivery of PROM at secondary health care. METHODS: It was a retrospective case-control study within a year observational period. Data were collected from medical records at St. Khadijah I Mother and Child Hospital Makassar. RESULTS: There were 4003 samples with 259 cases with PROM. Parity and body mass index (BMI) were factors associated with PROM with p=0.000 and .032 consecutively; among them, BMI was more prominent than parity with OR=2.392, and 95% CI=1.052-5.442. Cesarean section is not associated with PROM, p=.000. CONCLUSION: Primigravidae and obesity were factors associated with PROM, and BMI was more strongly associated with PROM than parity. PROM is not an indication for cesarean section.

Factors associated with and mode of delivery in prelabour rupture of membrane at secondary health care

Objective: The study aimed to explore factors associated with prelabor rupture of membrane (PROM) and mode of delivery of PROM at secondary health care. Methods: It was a retrospective case-control study within a year observational period. Data were collected from medical records at St. Khadijah I Mother and Child Hospital Makassar. Results: There were 4003 samples with 259 cases with PROM. Parity and body mass index (BMI) were factors associated with PROM with p = 0.000 and .032 consecutively; among them, BMI was more prominent than parity with OR = 2.392, and 95% CI = 1.052–5.442. Cesarean section is not associated with PROM, p = .000. Conclusion: Primigravidae and obesity were factors associated with PROM, and BMI was more strongly associated with PROM than parity. PROM is not an indication for cesarean section. (AU)