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.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01890005

Enrollment

476

Registered

2013-07-01

Start date

2013-07-31

Completion date

2014-01-31

Last updated

2013-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia

Keywords

Preeclampsia, Low dose aspirin, Fetal growth restriction, Neonatal death, Stillbirth, Abruptio placenta

Brief 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.

Interventions

DRUGAspirin

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

DRUGPlacebo

Placebo starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Stillbirth	6 months	The number of cases of stillbirths that appear in both groups at any given time during pregnancy.
Neonatal deaths	6 months	The number of cases of neonatal deaths that appear in both groups, regardless of the cause.
Prevention of preeclampsia at term	6 months	The number of cases of preeclampsia that appear in both groups between 37 and 41 weeks of pregnancy.
Abruptio placenta	6 months	The number of cases of abruptio placenta that appear in both groups at any given time during pregnancy.
Fetal Growth Restriction	6 months	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.
Neonatal intensive care unit admissions.	28 days	The number of cases that require admittance to the Neonatal Intensive Care Unit in both groups in the first 28 days after birth.

Countries

Panama

Contacts

Primary ContactRodrigo Velarde, MD

revelarde_14@yahoo.es

Backup ContactOsvaldo Reyes, MD

oreyespanama@yahoo.es

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026