Low Dose Aspirin for the Prevention of Preeclampsia

Phase 3

• Conditions: Preeclampsia
• Interventions: Drug: Placebo; Drug: Aspirin

• Registration Number: NCT01890005
• Lead Sponsor: Saint Thomas Hospital, Panama

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-06
• Study First Submitted: 2013-06-26
• Study First Submitted QC: 2013-06-28
• Last Update Submitted: 2013-06-28
• Study Start: 2013-07
• Study First Posted: 2013-07-01
• Last Update Posted: 2013-07-01
• Primary Completion: 2013-12
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 476

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Prevention of preeclampsia	6 months	The number of cases of preeclampsia that appear in both groups before 34 weeks of pregnancy

Secondary Outcome Measures

Name	Time	Method
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.
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.
Stillbirth	6 months	The number of cases of stillbirths that appear in both groups at any given time during 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.

Trial Locations

Locations (1)

Saint Thomas Maternity Hospital; 🇵🇦 Panama, Panama