Low Dose Aspirin for the Prevention of Preeclampsia
Information source: Saint Thomas Hospital, Panama
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Preeclampsia
Intervention: Aspirin (Drug); Placebo (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Saint Thomas Hospital, Panama Official(s) and/or principal investigator(s): Osvaldo Reyes, MD, Principal Investigator, Affiliation: Saint Thomas Maternity Hospital Rodrigo Velardee, MD, Principal Investigator, Affiliation: Saint Thomas Maternity Hospital Ameth Hawkins, MD, Principal Investigator, Affiliation: Saint Thomas Maternity Hospital Ana Moreno, MD, Principal Investigator, Affiliation: Saint Thomas Maternity Hospital
Overall contact: Rodrigo Velarde, MD, Email: revelarde_14@yahoo.es
Summary
Preeclampsia is one of the three leading causes of maternal morbidity and mortality all over
the world. The use of low dose aspirin has been mentioned in several studies with
promising results. The investigators decided to evaluate the use of low dose aspirin,
starting between 13 and 16 weeks of pregnancy, based on clinical characteristics only to
reduce the incidence of preeclampsia.
Clinical Details
Official title: Low Dose Aspirin Between 13 and 16 Weeks of Pregnancy for the Prevention of Preeclampsia. Double Blind, Randomized, Controlled Trial.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Prevention of preeclampsia
Secondary outcome: Prevention of preeclampsia at termStillbirth Neonatal deaths Neonatal intensive care unit admissions. Abruptio placenta Fetal Growth Restriction
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Gestational age between 13 and 16 weeks of pregnancy
- 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:
- Blood coagulation disorders of any kind
- Peptic ulcers
- Allergy to aspirin
- Chronic use of anti-inflammatory drugs
- Fetus with mayor anomalies
Locations and Contacts
Rodrigo Velarde, MD, Email: revelarde_14@yahoo.es
Saint Thomas Maternity Hospital, Panama, Panama; Not yet recruiting Rodrigo Velarde, MD, Email: revelarde_14@yahoo.es Osvaldo Reyes, MD, Email: oreyespanama@yahoo.es Osvaldo Reyes, MD, Principal Investigator Rodrigo Velarde, MD, Principal Investigator
Additional Information
Starting date: July 2013
Last updated: June 28, 2013
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