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
  Purpose

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.


Condition Intervention Phase
Preeclampsia
Drug: Aspirin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Low Dose Aspirin Between 13 and 16 Weeks of Pregnancy for the Prevention of Preeclampsia. Double Blind, Randomized, Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Saint Thomas Hospital, Panama:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 476
Study Start Date: July 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aspirin
Low dose aspirin (100 mg) starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.
Drug: Aspirin
Low dose aspirin (100 mg) starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.
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.
Drug: Placebo
Placebo starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01890005

Contacts
Contact: Rodrigo Velarde, MD revelarde_14@yahoo.es
Contact: Osvaldo Reyes, MD oreyespanama@yahoo.es

Locations
Panama
Saint Thomas Maternity Hospital Not yet recruiting
Panama, Panama
Contact: Rodrigo Velarde, MD       revelarde_14@yahoo.es   
Contact: Osvaldo Reyes, MD       oreyespanama@yahoo.es   
Principal Investigator: Osvaldo Reyes, MD         
Principal Investigator: Rodrigo Velarde, MD         
Sponsors and Collaborators
Saint Thomas Hospital, Panama
Investigators
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
  More Information

No publications provided

Responsible Party: Osvaldo A. Reyes T., Coordinator of Research, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier: NCT01890005     History of Changes
Other Study ID Numbers: MHST2013-05
Study First Received: June 26, 2013
Last Updated: June 28, 2013
Health Authority: Ministry of Health: Panama

Keywords provided by Saint Thomas Hospital, Panama:
Preeclampsia
Low dose aspirin
Fetal growth restriction
Neonatal death
Stillbirth
Abruptio placenta

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Aspirin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014