Low Dose Aspirin for the Prevention of Preeclampsia

Saint Thomas Hospital (HST)

Status and phase: Unknown; Phase 3

Conditions: Preeclampsia

Treatments: Drug: Aspirin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01890005

MHST2013-05

Details and patient eligibility

About

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.

Enrollment: 476 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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476 participants in 2 patient groups, including a placebo group

Aspirin

Experimental group

Description:

Low dose aspirin (100 mg) starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.

Treatment:

Drug: Aspirin

Placebo

Placebo Comparator group

Description:

Placebo (identical to low dose aspirin (100 mg)) starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.

Treatment:

Drug: Placebo