Aspirin for Prevention of Preeclampsia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2021-01-01

Brief Summary

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Prophylaxis with low-dose aspirin has been recommended to prevent preeclampsia, the rationale being that hypertension and abnormalities of coagulation in this disease are caused in part by an imbalance between vasodilating and vasoconstricting prostaglandins. Low-dose aspirin therapy inhibits thromboxane production more than prostacyclin production and therefore should protect against vasoconstriction and pathologic blood coagulation in the placenta. Initially, several single-center trials, mostly among women at increased risk for preeclampsia, demonstrated a substantial reduction in the risk of proteinuric hypertension as well as reductions in the incidences of preterm birth, infants small for gestational age, and perinatal death,

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Detailed Description

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This will be a randomized control trial to estimate the efficacy of two doses (80 mg versus 160 mg) of aspirin for prevention of preeclampsia in High-Risk Pregnant Women identified in the first trimester to be at high risk.

Conditions

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Preeclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This will be a randomized control trial to estimate the efficacy of two doses (80 mg versus 160 mg) of aspirin for prevention of preeclampsia in High-Risk Pregnant Women identified in the first trimester to be at high risk.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

both participants and researchers will be blinded to the intervention given.

Study Groups

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aspirin 162 mg

Aspirin 81mg two tablet once a day from recruitment until 37 weeks or labor whichever comes first

Group Type ACTIVE_COMPARATOR

aspirin 162 mg

Intervention Type DRUG

Aspirin 81mg two tablet once a day from recruitment until 37 weeks or labor whichever comes first

aspirin 81 mg plus placebo

Aspirin 81mg two tablet once a day from recruitment until 37 weeks or labor whichever comes first plus placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first

Group Type ACTIVE_COMPARATOR

aspirin 81 mg

Intervention Type DRUG

Aspirin 81mg one tablet once a day from recruitment until 37 weeks or labor whichever comes first

placebo

Intervention Type DRUG

placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first

Interventions

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aspirin 162 mg

Aspirin 81mg two tablet once a day from recruitment until 37 weeks or labor whichever comes first

Intervention Type DRUG

aspirin 81 mg

Aspirin 81mg one tablet once a day from recruitment until 37 weeks or labor whichever comes first

Intervention Type DRUG

placebo

placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first

Intervention Type DRUG

Other Intervention Names

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Active Comparator active comparator Placebo to asprin

Eligibility Criteria

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Inclusion Criteria

* Pregnant women presenting prior to 17+0 weeks' gestation.
* Moderate to high risk of preeclampsia.
* One or more of the following: previous history of preeclampsia, antiphospholipid antibodies, pre-existing diabetes, pre-existing hypertension, pre-existing renal disease, autoimmune disease, nulliparity, family history of preeclampsia, elevated BMI \> 25, and maternal age \<20 or \>35.
* Give written informed consent.

Exclusion Criteria

* Multiple gestations,
* fetal aneuploidy
* major fetal structural anomaly
* bleeding disorder
* allergy to aspirin
* women already on aspirin or heparin.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No