Study Results
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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UNKNOWN
PHASE3
476 participants
INTERVENTIONAL
2013-07-31
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Aspirin
Low dose aspirin (100 mg) starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.
Aspirin
Low dose aspirin (100 mg) starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.
Placebo
Placebo (identical to low dose aspirin (100 mg)) starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.
Placebo
Placebo starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.
Interventions
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Aspirin
Low dose aspirin (100 mg) starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.
Placebo
Placebo starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.
Eligibility Criteria
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Inclusion Criteria
* High risk of preeclampsia, based in clinical risk factors as:
Preeclampsia in a previous pregnancy Mother or sister that developed preeclampsia in a previous pregnancy Diabetes Mellitus (insulin dependant) Chronic Hypertension (with/without proteinuria) Body Mass Index \> 32 Multiple pregnancy Lupus or other autoimmune disorder Chronic Renal Disease.
Exclusion Criteria
* Peptic ulcers
* Allergy to aspirin
* Chronic use of anti-inflammatory drugs
* Fetus with mayor anomalies
FEMALE
No
Sponsors
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Saint Thomas Hospital, Panama
OTHER
Responsible Party
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Osvaldo A. Reyes T.
Coordinator of Research
Principal Investigators
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Osvaldo Reyes, MD
Role: PRINCIPAL_INVESTIGATOR
Saint Thomas Maternity Hospital
Rodrigo Velardee, MD
Role: PRINCIPAL_INVESTIGATOR
Saint Thomas Maternity Hospital
Ameth Hawkins, MD
Role: PRINCIPAL_INVESTIGATOR
Saint Thomas Maternity Hospital
Ana Moreno, MD
Role: PRINCIPAL_INVESTIGATOR
Saint Thomas Maternity Hospital
Locations
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Saint Thomas Maternity Hospital
Panama City, , Panama
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MHST2013-05
Identifier Type: -
Identifier Source: org_study_id
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