Low Dose Aspirin for the Prevention of Preeclampsia

Preeclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01890005
• Other study ID #: MHST2013-05
• Status: Not yet recruiting
• Phase: Phase 3
• First received: June 26, 2013
• Last updated: June 28, 2013
• Start date: July 2013
• Est. completion date: January 2014

Study information

• Verified date: June 2013
• Source: Saint Thomas Hospital, Panama
• Contact: Rodrigo Velarde, MD
• Email: revelarde_14[@]yahoo.es
• Is FDA regulated: No
• Health authority: Ministry of Health: Panama
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 476
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

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

Locations

Country	Name	City	State
Panama	Saint Thomas Maternity Hospital	Panama

Sponsors (1)

Lead Sponsor	Collaborator
Saint Thomas Hospital, Panama

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of preeclampsia	The number of cases of preeclampsia that appear in both groups before 34 weeks of pregnancy	6 months	No
Secondary	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	No
Secondary	Stillbirth	The number of cases of stillbirths that appear in both groups at any given time during pregnancy.	6 months	No
Secondary	Neonatal deaths	The number of cases of neonatal deaths that appear in both groups, regardless of the cause.	6 months	No
Secondary	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	No
Secondary	Abruptio placenta	The number of cases of abruptio placenta that appear in both groups at any given time during pregnancy.	6 months	Yes
Secondary	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	No