NCT01890005

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
476

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

July 1, 2013

Status Verified

June 1, 2013

Enrollment Period

5 months

First QC Date

June 26, 2013

Last Update Submit

June 28, 2013

Conditions

Preeclampsia

Keywords

PreeclampsiaLow dose aspirinFetal growth restrictionNeonatal deathStillbirthAbruptio placenta

Outcome Measures

Primary Outcomes (1)

  • Prevention of preeclampsia

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

    6 months

Secondary Outcomes (6)

  • Prevention of preeclampsia at term

    6 months

  • Stillbirth

    6 months

  • Neonatal deaths

    6 months

  • Neonatal intensive care unit admissions.

    28 days

  • Abruptio placenta

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Aspirin

EXPERIMENTAL

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

Drug: Aspirin

Placebo

PLACEBO COMPARATOR

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

Interventions

AspirinDRUG

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

Aspirin
PlaceboDRUG

Placebo starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.

Placebo

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Blood coagulation disorders of any kind
  • Peptic ulcers
  • Allergy to aspirin
  • Chronic use of anti-inflammatory drugs
  • Fetus with mayor anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Thomas Maternity Hospital

Panama City, Panama

Location

MeSH Terms

Conditions

Pre-EclampsiaFetal Growth RetardationPerinatal DeathStillbirthAbruptio Placentae

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFetal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsDeathFetal DeathObstetric Labor ComplicationsPlacenta Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodrigo Velarde, MD

CONTACT

revelarde_14@yahoo.es

Osvaldo Reyes, MD

CONTACT

oreyespanama@yahoo.es

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinator of Research

Study Record Dates

First Submitted

June 26, 2013

First Posted

July 1, 2013

Study Start

July 1, 2013

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

July 1, 2013

Record last verified: 2013-06

Locations

PA(1)