Metformin and Aspirin Versus Only Aspirin for Prevention of Preeclampsia: A Randomized Controlled Trial

Background: Preeclampsia is a pregnancy specific multiorgan involved disease characterized by de novo development of hypertension, proteinuria and/or any other end organ failure after 20 weeks of gestation. Preeclampsia is associated with two stages model of the placental dysfunction. An important step in the pathogenesis of preeclampsia is poor placental invasion. Significant efforts have been devoted to developing clinically useful screening methods and prevention strategies for pre-eclampsia. Early prediction and additional interventions could boost the beneficial effects of aspirin. The objective of this Randomized Controlled Trial study was to find out whether Metformin along with Aspirin is associated with significant reduction of incidence of Preeclampsia.

Method: The RCT was carried out involving 80 women (40 in control group and 40 in experimental group) in early pregnancy (6-12 weeks) attending the Fetomaternal Medicine OPD during the period of January 2022 to December 2022. The control group has received tab Aspirin 150 mg at bedtime and the intervention group took 500mg Metformin twice daily along with Aspirin. Aspirin was discontinued at 36 weeks or before 24 hours if delivery was anticipated. Metformin was continued up to 36 weeks. They were monitored regularly up to delivery to observe the outcome (development of Preeclampsia). Then comparison was done between intervention and control group to see the efficacy of Metformin in the intervention group. Collected data were processed and analyzed using SPSS (Statistical Package for Social Sciences), version 25.

Result: Total 80 respondents were included in this study. In this study, among the patients with 18-25 years, 30.4% suffered from preeclampsia; whereas among the participants with 25-30 years, the proportion of Preeclampsia was 50%. In this study, more than 50% of the participants were overweight and 13.8% were obese. Only 1(1.3%) was underweight .The major risk factors or comorbidities among the study participants was Diabetes in Pregnancy (32.5%) followed by Chronic Hypertension (25.0%) and previous history of Preeclampsia (20.0%) and family history of Preeclampsia (15.0%).In the intervention group 37.5% patients suffered from preeclampsia and in the control group the proportion was 60%.In the intervention group, 86.7% patients suffered preeclampsia at ≤34 weeks of gestation, whereas in control group 91.7% patients experienced preeclampsia at ≤34 weeks In 62.5% cases, the intervention was able to prevent preeclampsia and on the other hand ,control was able to prevent 40.0% preeclampsia. Thus, this difference in preventing preeclampsia was significantly higher in the intervention group (p value: 0.044).

Conclusion: The result of this study indicated that pregnant women with high risk can be treated with both Metformin and Aspirin from the first trimester for prevention of Preeclampsia.

Keywords: Preeclampsia, Prevention, Aspirin, Metformin.