Early Prevention of Preeclampsia Study
| Status: | Terminated |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2018 |
| Start Date: | March 2012 |
| End Date: | July 20, 2015 |
Early Prediction and Aspirin for Prevention of Preeclampsia
This is a randomized controlled trial to estimate the efficacy of low dose aspirin for
preventing preeclampsia in women identified as high risk. The investigators hypothesize that
the risk of preeclampsia in women identified by a first trimester multiparameter predictive
model to be at high risk will be significantly reduced by initiating low dose aspirin early
in pregnancy.
preventing preeclampsia in women identified as high risk. The investigators hypothesize that
the risk of preeclampsia in women identified by a first trimester multiparameter predictive
model to be at high risk will be significantly reduced by initiating low dose aspirin early
in pregnancy.
This will be a randomized control trial to estimate the efficacy of low dose aspirin in
preventing preeclampsia in women identified in the first trimester to be at high risk. We
will also obtain maternal blood, cord blood and placenta specimen for basic science studies
to attempt to dissect biological mechanisms of aspirin effects. In addition we will conduct a
cost-benefit analysis to determine the cost effectiveness of screening and using aspirin
prophylaxis for screen positive women.
Rationale for Design: The randomized control trial is the 'gold standard' of research design.
Other designs such as case-control, retrospective cohort and prospective cohort are limited
by potential bias and confounding. Randomly assigning subjects to different interventions
minimizes selection bias. The random assignment also results in groups that are likely to be
similar with regards to important confounding variables. This minimizes confounding by both
measured and unmeasured factors. While random allocation does not guarantee the groups will
be identical, it does ensure that any differences between them are due to chance alone.
Finally, randomization produces groups that are random samples of the population. This
permits use of standard statistical tests that are based on probability theory.
preventing preeclampsia in women identified in the first trimester to be at high risk. We
will also obtain maternal blood, cord blood and placenta specimen for basic science studies
to attempt to dissect biological mechanisms of aspirin effects. In addition we will conduct a
cost-benefit analysis to determine the cost effectiveness of screening and using aspirin
prophylaxis for screen positive women.
Rationale for Design: The randomized control trial is the 'gold standard' of research design.
Other designs such as case-control, retrospective cohort and prospective cohort are limited
by potential bias and confounding. Randomly assigning subjects to different interventions
minimizes selection bias. The random assignment also results in groups that are likely to be
similar with regards to important confounding variables. This minimizes confounding by both
measured and unmeasured factors. While random allocation does not guarantee the groups will
be identical, it does ensure that any differences between them are due to chance alone.
Finally, randomization produces groups that are random samples of the population. This
permits use of standard statistical tests that are based on probability theory.
Inclusion Criteria:
- Singleton pregnancy undergoing ultrasound examination at 9 0/7 - 14 6/7 weeks
- any one or more factors identified as high risk from the identified risk factors:
Chronic hypertension, prepregnancy diabetes mellitus, previous preeclampsia, obesity
(BMI >30), bilateral uterine artery notches preeclampsia risk score greater than 6,
low PAPP-A ( < 0.52 MoM)
Exclusion Criteria:
- Multiple gestations,
- fetal aneuploidy
- major fetal structural anomaly
- bleeding disorder
- allergy to aspirin
- women already on aspirin or heparin.
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