Clinical trial NCT01547390: Early Prevention of Preeclampsia Study
Official title: Early Prediction and Aspirin for Prevention of Preeclampsia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Preeclampsia
Keywords: preeclampsia
Aspirin
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2012-03-07
Enrollment: 104
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Preeclampsia
timeFrame: within 3 months prior to delivery
Secondary outcomes:
measure: Number of Participants With IUGR, Early Preeclampsia, Severe Preeclampsia, Gestational Hypertension, Preterm Birth, Stillbirth, Placental Abruption, Antepartum Hemorrhage, Neonatal Death, NICU Admission, Miscarriage
timeFrame: within 3 months of delivery
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Anthony Odibo, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Odibo AO, Goetzinger KR, Odibo L, Tuuli MG. Early prediction and aspirin for prevention of pre-eclampsia (EPAPP) study: a randomized controlled trial. Ultrasound Obstet Gynecol. 2015 Oct;46(4):414-8. doi: 10.1002/uog.14889. Epub 2015 Aug 31.