Clinical Trial: Low Dose Aspirin for the Prevention of Preeclampsia

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:
Sponsor: Saint Thomas Hospital, Panama

Current Primary Outcome: Prevention of preeclampsia [ Time Frame: 6 months ]

The number of cases of preeclampsia that appear in both groups before 34 weeks of pregnancy


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Prevention of preeclampsia at term [ Time Frame: 6 months ]
    The number of cases of preeclampsia that appear in both groups between 37 and 41 weeks of pregnancy.
  • Stillbirth [ Time Frame: 6 months ]
    The number of cases of stillbirths that appear in both groups at any given time during pregnancy.
  • Neonatal deaths [ Time Frame: 6 months ]
    The number of cases of neonatal deaths that appear in both groups, regardless of the cause.
  • Neonatal intensive care unit admissions. [ Time Frame: 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.
  • Abruptio placenta [ Time Frame: 6 months ]
    The number of cases of abruptio placenta that appear in both groups at any given time during pregnancy.
  • Fetal Growth Restriction [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Saint Thomas Hospital, Panama

Dates:
Date Received: June 26, 2013
Date Started: July 2013
Date Completion: January 2014
Last Updated: June 28, 2013
Last Verified: June 2013