Oral Concurrent Session 4 - Hypertension
Oral Concurrent Sessions
Farah H. Amro, MD
Assistant Professor
McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth)
Houston, TX, United States
.jpg "Michal Fishel Bartal, MD (she/her/hers) photo")
Michal Fishel Bartal, MD (she/her/hers)
Maternal Fetal Medicine Faculty
McGovern Medical School at UTHealth Houston, Sheba Medical Center, Tel Hashomer, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel
Houston, TX, United States
Claudia Pedroza, PhD
McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth)
Houston, TX, United States
Sami Backley, MD
Clinical Fellow PGY 8
McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth)
Houston, TX, United States
Ghamar Bitar, MD
McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth)
Houston, TX, United States
Joseph Lucci IV, BS
McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth)
Houston, TX, United States
Nahla Daye, MD
McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth)
Houston, TX, United States
Sandra Sadek, MD
McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth)
Houston, TX, United States
Low dose aspirin is recommended for preeclampsia prevention; however, the optimal dose is debated. We evaluated whether daily dose of aspirin (162 mg) compared to routine dose (81 mg) decreases the rate of preeclampsia (PE) with severe features in high-risk obese individuals.
Study Design:
Pregnant individuals 12-20 weeks with a BMI ≥ 30 kg/m2 and at least one high-risk factor (history of PE, pregestational diabetes, gestational diabetes diagnosed < 20 weeks, or at least stage I hypertension [≥130/80]) were randomly allocated to aspirin dose of 81 mg or 162 mg (ClinicalTrials.gov: NCT03961360). Adherence to medications was assessed at 4 weeks after enrollment and at 32-36 weeks. Primary outcome was rate of PE with severe features based on physician diagnosis in those delivered ≥ 20 weeks. We used Bayesian methodology to determine a total sample size of 220 subjects needed to determine whether higher aspirin dosing would decrease the primary outcome, assuming 80% power, a neutral informative prior, and 75% certainty. An intention-to-treat analyses was used to calculate relative risk (RR), 95% credible intervals (CI).
Results:
Over the study period (05/2019 to 11/2022) 343 eligible women were approached and 220 (64%) agreed. High risk factors were similar between groups (history of prior PE: 34% vs 29%, diabetes mellitus: 42% vs 46%, Stage I HTN: 29% vs 32%). Primary outcome was unavailable for 7 (3%) participants,4 (1.8%) delivered prior to 20 weeks.Thus, we analyzed:107 on 162 mg and 102 on 81 mg.PE with severe features occurred in 35% in 162 mg compared to 40% in the 81 mg group(RR, 0.88, 95% credible interval, 0.64-1.22)with a posterior probability for treatment benefit of 78% (Table).The median gestational age at delivery was lower in 162 mg group (p=0.04), however there were no differences in other secondary outcomes or medication adverse events (Table).
Conclusion:
Among high-risk obese individuals our trial suggests with 78% certainty that 162 mg aspirin compared to 81 mg, decreases PE with severe features.This trial supports doing a larger phase III multicenter trial.