Low Dose Aspirin for the Prevention of Preeclampsia

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by Saint Thomas Hospital, Panama
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier:
NCT01890005
First received: June 26, 2013
Last updated: June 28, 2013
Last verified: June 2013

June 26, 2013
June 28, 2013
July 2013
December 2013   (final data collection date for primary outcome measure)
Prevention of preeclampsia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The number of cases of preeclampsia that appear in both groups before 34 weeks of pregnancy
Same as current
Complete list of historical versions of study NCT01890005 on ClinicalTrials.gov Archive Site
  • Prevention of preeclampsia at term [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The number of cases of preeclampsia that appear in both groups between 37 and 41 weeks of pregnancy.
  • Stillbirth [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The number of cases of stillbirths that appear in both groups at any given time during pregnancy.
  • Neonatal deaths [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Preeclampsia
  • Drug: Aspirin
    Low dose aspirin (100 mg) starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.
  • Drug: Placebo
    Placebo starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.
  • Experimental: Aspirin
    Low dose aspirin (100 mg) starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.
    Intervention: Drug: Aspirin
  • Placebo Comparator: 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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
476
January 2014
December 2013   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact: Rodrigo Velarde, MD revelarde_14@yahoo.es
Contact: Osvaldo Reyes, MD oreyespanama@yahoo.es
Panama
 
NCT01890005
MHST2013-05
No
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
Saint Thomas Hospital, Panama
Not Provided
Principal Investigator: Osvaldo Reyes, MD Saint Thomas Maternity Hospital
Principal Investigator: Rodrigo Velardee, MD Saint Thomas Maternity Hospital
Principal Investigator: Ameth Hawkins, MD Saint Thomas Maternity Hospital
Principal Investigator: Ana Moreno, MD Saint Thomas Maternity Hospital
Saint Thomas Hospital, Panama
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP