Low Dose Aspirin for the Prevention of Preeclampsia

S

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

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

Trial contacts and locations

1

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Central trial contact

Rodrigo Velarde, MD; Osvaldo Reyes, MD

Data sourced from clinicaltrials.gov

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