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Low Dose Aspirin for the Prevention of Preeclampsia

Primary Purpose

Preeclampsia

Status
Unknown status
Phase
Phase 3
Locations
Panama
Study Type
Interventional
Intervention
Aspirin
Placebo
Sponsored by
Saint Thomas Hospital, Panama
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preeclampsia focused on measuring Preeclampsia, Low dose aspirin, Fetal growth restriction, Neonatal death, Stillbirth, Abruptio placenta

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Saint Thomas Maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aspirin

Placebo

Arm Description

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

Placebo (identical to low dose aspirin (100 mg)) starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Prevention of preeclampsia at term
The number of cases of preeclampsia that appear in both groups between 37 and 41 weeks of pregnancy.
Stillbirth
The number of cases of stillbirths that appear in both groups at any given time during pregnancy.
Neonatal deaths
The number of cases of neonatal deaths that appear in both groups, regardless of the cause.
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.
Abruptio placenta
The number of cases of abruptio placenta that appear in both groups at any given time during pregnancy.
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.

Full Information

First Posted
June 26, 2013
Last Updated
June 28, 2013
Sponsor
Saint Thomas Hospital, Panama
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1. Study Identification

Unique Protocol Identification Number
NCT01890005
Brief Title
Low Dose Aspirin for the Prevention of Preeclampsia
Official Title
Low Dose Aspirin Between 13 and 16 Weeks of Pregnancy for the Prevention of Preeclampsia. Double Blind, Randomized, Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
January 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint Thomas Hospital, Panama

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia
Keywords
Preeclampsia, Low dose aspirin, Fetal growth restriction, Neonatal death, Stillbirth, Abruptio placenta

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
476 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aspirin
Arm Type
Experimental
Arm Description
Low dose aspirin (100 mg) starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Low dose aspirin (100 mg) starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.
Primary Outcome Measure Information:
Title
Prevention of preeclampsia
Description
The number of cases of preeclampsia that appear in both groups before 34 weeks of pregnancy
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Prevention of preeclampsia at term
Description
The number of cases of preeclampsia that appear in both groups between 37 and 41 weeks of pregnancy.
Time Frame
6 months
Title
Stillbirth
Description
The number of cases of stillbirths that appear in both groups at any given time during pregnancy.
Time Frame
6 months
Title
Neonatal deaths
Description
The number of cases of neonatal deaths that appear in both groups, regardless of the cause.
Time Frame
6 months
Title
Neonatal intensive care unit admissions.
Description
The number of cases that require admittance to the Neonatal Intensive Care Unit in both groups in the first 28 days after birth.
Time Frame
28 days
Title
Abruptio placenta
Description
The number of cases of abruptio placenta that appear in both groups at any given time during pregnancy.
Time Frame
6 months
Title
Fetal Growth Restriction
Description
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.
Time Frame
6 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rodrigo Velarde, MD
Email
revelarde_14@yahoo.es
First Name & Middle Initial & Last Name or Official Title & Degree
Osvaldo Reyes, MD
Email
oreyespanama@yahoo.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osvaldo Reyes, MD
Organizational Affiliation
Saint Thomas Maternity Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rodrigo Velardee, MD
Organizational Affiliation
Saint Thomas Maternity Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ameth Hawkins, MD
Organizational Affiliation
Saint Thomas Maternity Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ana Moreno, MD
Organizational Affiliation
Saint Thomas Maternity Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Thomas Maternity Hospital
City
Panama
Country
Panama
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo Velarde, MD
Email
revelarde_14@yahoo.es
First Name & Middle Initial & Last Name & Degree
Osvaldo Reyes, MD
Email
oreyespanama@yahoo.es
First Name & Middle Initial & Last Name & Degree
Osvaldo Reyes, MD
First Name & Middle Initial & Last Name & Degree
Rodrigo Velarde, MD

12. IPD Sharing Statement

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Low Dose Aspirin for the Prevention of Preeclampsia

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