Comparison of 75 mg versus 150 mg Aspirin for prevention of preterm preeclampsia in high risk women at Tertiary level hospital-A Randomized double blind clinical trial

1. Rationale/ gaps in existing knowledge-

Lack of evidence about: i). Optimum dose of aspirin ,75 versus 150 mg, for prevention of preterm PE. ii). When to start and stop aspirin during pregnancy for prevention of preterm PE.

Novelty- No international or Indian prospective randomized double blind interventional trial comparing 75mg vs 150mg Aspirin for prevention of preterm PE in high risk /screen positive women.

Objectives-To compare 75 mg versus 150 mg Aspirin, for prevention of preterm preeclampsia in high risk women .

Methods- All women attending ANC and Fetal medicine OPD of VMMC & Safdarjung hospital between 11- 13+6 weeks of gestational age will be screened for preterm PE using first trimester Quadruple test. Women with risk for preterm PE , ≥1:100 will be labelled  as Screen positive. 1T Quad will be done using Perkin Elmer LifeCycle 7.0 software by DELFIA. Screen positive women fulfilling the criteria will be enrolled and randomized using randomization chart into two groups, Group A and B to receive 75 mg or 150 mg Aspirin respectively at night , from 12 -16 weeks of pregnancy. The blinding of the trial drugs will be done by sequential number order method. Both groups will be followed up and onset of preterm PE, fetomaternal outcome and side effects of Aspirin will be recorded. Data will be coded and recorded in MS Excel spreadsheet program. SPSS v23 (IBM Corp.) will be used for data analysis and p < 0.05 will be considered as statistically significant.

**Expected outcome-**Number of screen positive women developing preterm PE, various fetomaternal outcomes and aspirin side effects in 75 mg versus 150 mg Aspirin group.