Early Prevention of Preeclampsia Study (EPAPP)
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| ClinicalTrials.gov Identifier: NCT01547390 |
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Recruitment Status :
Completed
First Posted : March 7, 2012
Results First Posted : May 14, 2018
Last Update Posted : May 14, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Preeclampsia | Drug: Aspirin Drug: placebo | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 104 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Early Prediction and Aspirin for Prevention of Preeclampsia |
| Study Start Date : | March 2012 |
| Actual Primary Completion Date : | July 20, 2015 |
| Actual Study Completion Date : | July 20, 2015 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Aspirin
Aspirin 81mg one tablet once a day from recruitment until 37 weeks or labor whichever comes first
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Drug: Aspirin |
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Placebo Comparator: placebo
placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first
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Drug: placebo |
- Preeclampsia [ Time Frame: within 3 months of delivery ]Preeclampsia diagnosed per ACOG criteria: Blood pressure greater than 140/90 on 2 occassions 6 hrs apart and significant proteinuria (greater than 300mg in 24hrs).
- Secondary Outcomes as Described Below [ Time Frame: within 3 months of delivery ]
Intrauterine growth restriction (IUGR) - estimated fetal weight less than 10th percentile early preeclampsia - preeclampsia delivered prior to 34 weeks severe preeclampsia - blood pressure greater then 160/110 gestational hypertension - hypertension without features of preeclampsia preterm birth, stillbirth, placental abruption, antepartum hemorrhage, neonatal death, NICU admission, miscarriage.
Statistical significance not reported due to the low recruitment and poor patient compliance.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01547390
| United States, Missouri | |
| Washington University | |
| Saint Louis, Missouri, United States, 63110 | |
| Principal Investigator: | Anthony Odibo, MD, MSCE | Washington University School of Medicine |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01547390 History of Changes |
| Other Study ID Numbers: |
201112007 |
| First Posted: | March 7, 2012 Key Record Dates |
| Results First Posted: | May 14, 2018 |
| Last Update Posted: | May 14, 2018 |
| Last Verified: | April 2018 |
Keywords provided by Washington University School of Medicine:
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preeclampsia Aspirin |
Additional relevant MeSH terms:
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Pre-Eclampsia Hypertension, Pregnancy-Induced Pregnancy Complications Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics |