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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 term

Stillbirth

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

Page last updated: August 20, 2015

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