# Estimating the Effect of Low-Dose Aspirin on Fetal Loss in a Trial with Non-Compliance

> **NIH NIH R01** · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · 2020 · $69,624

## Abstract

Project Summary/Abstract
 Miscarriage is the most common pregnancy outcome, and can have lasting psychological implications that
persist even after the birth of a healthy child. The few treatment options that exist are costly, potentially
invasive, undermine quality of life, or are associated with adverse sequelae. Aspirin is a well-tolerated over-
the-counter drug, but little is known about its effects on promoting live birth in women at high risk of recurrent
miscarriage. The Effects of Aspirin in Gestation and Reproduction (EAGeR) study was a randomized trial of the
effect of low-dose aspirin on preventing miscarriage and promoting live birth. While the study found a small
effect of aspirin on live birth, interpreting these results is complicated by several challenges that routinely affect
randomized trials. These include failure of study participants to comply with the assigned treatment, mis-
measurement of exposure to aspirin, and studying aspirin effects in a sample that is not representative of the
population of interest. Each of these creates the potential for incorrect inferences regarding treatment effects in
more general populations. We will reanalyze data from this prospective cohort study using tools that properly
account for each of these complications. Specifically, we will (Aim 1) estimate the effect of taking daily low
dose aspirin on miscarriage and successful live birth; (Aim 2) correct these effects estimates for potential
measurement error; and (Aim 3) generalize these effect estimates to clinically representative populations.
Successful completion of this work will fill critical gaps in knowledge about the benefits of aspirin in preventing
miscarriage and promoting live birth. Our cost-effective, efficient, and methodologically innovative project will
help guide clinicians and public health practitioners in making informed decisions about this simple and
inexpensive preventive strategy. Furthermore, by developing and disseminating our project's methods and
software programs, we will facilitate the widespread use of our state-of-the-art analytic techniques to account
for common problems in the analysis of randomized trials. Consequently, the impact of this project will be wide,
and will enable researchers in any substantive area to fully address critical issues that plague nearly all trials in
the biomedical and social sciences.

## Key facts

- **NIH application ID:** 9853828
- **Project number:** 5R01HD093602-03
- **Recipient organization:** UNIVERSITY OF PITTSBURGH AT PITTSBURGH
- **Principal Investigator:** Ashley Isaac Naimi
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $69,624
- **Award type:** 5
- **Project period:** 2018-04-01 → 2020-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9853828

## Citation

> US National Institutes of Health, RePORTER application 9853828, Estimating the Effect of Low-Dose Aspirin on Fetal Loss in a Trial with Non-Compliance (5R01HD093602-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9853828. Licensed CC0.

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