Low Dose Aspirin for the Prevention of Preeclampsia

Study Overview
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Brief Summary
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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.

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

Conditions
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Preeclampsia

Intervention / Treatment
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* Drug: Aspirin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preeclampsia, Low dose aspirin, Fetal growth restriction, Neonatal death, Stillbirth, Abruptio placenta