Comparison of Doses of Acetylsalicylic Acid in Women With Previous History of Preeclampsia

NCT01352234 | Completed Phase 4 DMC

• 1 other identifier: C10-11-108
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Placental insufficiency is the source of preeclampsia (PE) and intrauterine growth retardation (IUGR). Current data demonstrate a significant beneficial effect of prophylactic use of aspirin on the recurrence of placental insufficiency and its complications, mainly preeclampsia, when started early in pregnancy. However, there is a significant heterogeneity in medical practice in Canada and around the world in terms of the dose of aspirin used. The objectives of this study are: 1) Evaluate whether a dose of 160 mg of aspirin is associated with greater improvement in placental function assessed by biochemistry (sFlt-1 and endoglin) and ultrasound (uterine artery Doppler) than a dose of 80 mg in women with a history of PE, 2) Assess whether the change is dependent on platelet aggregation measured by a test used in several Canadian centers (PFA-100).

Conditions

Pre-Eclampsia; Fetal Growth Retardation; Premature Birth; Placental Insufficiency

Outcome Measures

Primary Outcomes (1)

• Placental function

  We chose a continuous intermediate variable focused on the aetiology, the placental function, assessed by Doppler ultrasound: the average pulsatility index of uterine arteries (UTAP - primary outcome) at 22 weeks of gestation

  22nd week of gestation

Secondary Outcomes (1)

• Rates of pregnancy complications related to placental insufficiency (preeclampsia, IUGR, premature birth)

  At delivery

Study Arms (2)

Group A

EXPERIMENTAL

Acetylsalicylic Acid 160mg administered at bedtime

Drug: Acetylsalicylic Acid 160 mg

Group B

ACTIVE COMPARATOR

Acetylsalicylic Acid 80mg administered at bedtime

Drug: Acetylsalicylic Acid 80 mg

Interventions

Acetylsalicylic Acid 160 mg DRUG

Capsule containing Acetylsalicylic Acid 160mg pill with lactose

Also known as: Asaphen, Aspirin, ASA

Group A

Acetylsalicylic Acid 80 mg DRUG

Capsule containing Acetylsalicylic Acid 80mg pill with lactose

Also known as: Asaphen, Aspirin, ASA

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gestational age between 10 0 / 7 and 13 6 / 7 weeks
• History of preeclampsia (as defined by The Society of Obstetricians and Gynaecologists of Canada) confirmed by medical records

You may not qualify if:

• Negative Fetal Heart
• Multiple pregnancy
• Anaphylactic allergy to lactose
• Kown coagulopathy (antithrombin III deficiency, factor V Leiden, antiphospholipid syndrome, the prothrombin mutation, deficiency of protein S or protein C)
• Use of heparin or other anticoagulants.
• Contraindications to aspirin
• Severe fetal abnormality (cystic hygroma, nuchal translucency\> 95th percentile, anencephaly, etc.)
• History or active peptic ulcer

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Study Sites (1)

Centre Hospitalier Universitaire de Québec (CHUQ)/Pavillon CHUL

Québec, G1V 4G2, Canada

Location

MeSH Terms

Conditions

Pre-Eclampsia; Fetal Growth Retardation; Premature Birth; Placental Insufficiency

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Placenta Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Emmanuel Bujold, MD, MSc

  CHU de Quebec-Universite Laval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2011
• First Posted: May 11, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: November 13, 2018

Record last verified: 2018-11

Locations

CA (1)