Low Dose Aspirin for the Prevention of Preeclampsia

Low Dose Aspirin Between 13 and 16 Weeks of Pregnancy for the Prevention of Preeclampsia. Double Blind, Randomized, Controlled Trial.

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.

Study Overview

• Status: Unknown
• Conditions: Preeclampsia
• Intervention / Treatment: Drug: Aspirin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 476
• Phase: Phase 3

Contacts and Locations

Study Locations

• Panama
  • Panama, Panama
    • Saint Thomas Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aspirin; Low dose aspirin (100 mg) starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.	Drug: Aspirin; Low dose aspirin (100 mg) starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.
Placebo Comparator: 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.	Drug: Placebo; Placebo starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevention of preeclampsia	The number of cases of preeclampsia that appear in both groups before 34 weeks of pregnancy	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevention of preeclampsia at term	The number of cases of preeclampsia that appear in both groups between 37 and 41 weeks of pregnancy.	6 months
Stillbirth	The number of cases of stillbirths that appear in both groups at any given time during pregnancy.	6 months
Neonatal deaths	The number of cases of neonatal deaths that appear in both groups, regardless of the cause.	6 months
Neonatal intensive care unit admissions.	The number of cases that require admittance to the Neonatal Intensive Care Unit in both groups in the first 28 days after birth.	28 days
Abruptio placenta	The number of cases of abruptio placenta that appear in both groups at any given time during pregnancy.	6 months
Fetal Growth Restriction	The number of cases of fetal growth restriction, defined as a fetal weight below the 10th percentile and an abnormal umbilical cord doppler that appear in both groups at any given time during pregnancy.	6 months

Collaborators and Investigators

• Sponsor: Saint Thomas Hospital, Panama
• Investigators: Principal Investigator: Osvaldo Reyes, MD, Saint Thomas Maternity Hospital; Principal Investigator: Rodrigo Velardee, MD, Saint Thomas Maternity Hospital; Principal Investigator: Ameth Hawkins, MD, Saint Thomas Maternity Hospital; Principal Investigator: Ana Moreno, MD, Saint Thomas Maternity Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): January 1, 2014

Study Registration Dates

• First Submitted: June 26, 2013
• First Submitted That Met QC Criteria: June 28, 2013
• First Posted (Estimate): July 1, 2013

Study Record Updates

• Last Update Posted (Estimate): July 1, 2013
• Last Update Submitted That Met QC Criteria: June 28, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Preeclampsia; Stillbirth; Fetal growth restriction; Low dose aspirin; Neonatal death; Abruptio placenta
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: MHST2013-05