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

Study Description

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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).

Condition or disease	Intervention/treatment	Phase
Pre-Eclampsia; Fetal Growth Retardation; Premature Birth; Placental Insufficiency	Drug: Acetylsalicylic Acid	Phase 4

Detailed Description:

Many studies suggest that aspirin (acetylsalicylic acid) at low dose significantly reduces the incidence of preeclampsia. More recent data have shown that, when administered before 16 weeks of pregnancy, aspirin can prevent over 50% of preeclampsia, severe preeclampsia, and IUGR but also a significant proportion of the rate of preterm births. Current data also demonstrate a beneficial effect of prophylactic use of aspirin when started early in pregnancy in populations composed of high-risk patients with a history of preeclampsia and / or other pregnancy complications related to poor placental function.

Beside, many clinicians are already using aspirin in the context of a proven benefit. However, the usual dose prescribed in Canada today is 80 mg while the most favorable studies have used a slightly higher dose of aspirin (100 mg).

Moreover, it has been demonstrated that the time of day during which aspirin was administered was also a very important factor regarding the effect on blood pressure and adverse outcomes of the majority of pregnancy. Yet the majority of studies in this context have not specified the time of day at which aspirin was or had been taken, possibly underestimating the effect thereof.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	104 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Evaluation of Dose-response Effect of Acetylsalicylic Acid on Placental Development, Preterm Birth, Fetal Growth and Hypertension in Pregnancy in Women With Previous History of Preeclampsia
Study Start Date :	September 2011
Actual Primary Completion Date :	December 2014
Actual Study Completion Date :	March 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Group A; Acetylsalicylic Acid 160mg administered at bedtime	Drug: Acetylsalicylic Acid; Capsule containing Acetylsalicylic Acid 160mg pill with lactose; Other Names: Asaphen; Aspirin; ASA
Active Comparator: Group B; Acetylsalicylic Acid 80mg administered at bedtime	Drug: Acetylsalicylic Acid; Capsule containing Acetylsalicylic Acid 80mg pill with lactose; Other Names: Asaphen; Aspirin; ASA

Outcome Measures

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Primary Outcome Measures :

1. Placental function [ Time Frame: 22nd week of gestation ]
   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

Secondary Outcome Measures :

1. Rates of pregnancy complications related to placental insufficiency (preeclampsia, IUGR, premature birth) [ Time Frame: At delivery ]
   The effectiveness of treatment on the rate of preterm delivery, hypertensive disorders of pregnancy and IUGR will also be measured by reviewing medical records. All cases with a diagnosis of preterm labor, gestational hypertension or IUGR <10th percentile will be reviewed by a specialist in maternal fetal medicine at blindness for allocation.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

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Locations

Canada, Quebec
Centre Hospitalier Universitaire de Québec (CHUQ)/Pavillon CHUL
Québec, Quebec, Canada, G1V 4G2

Sponsors and Collaborators

CHU de Quebec-Universite Laval

Investigators

Principal Investigator:	Emmanuel Bujold, MD, MSc	CHU de Quebec-Universite Laval

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier:	NCT01352234 History of Changes
Other Study ID Numbers:	C10-11-108
First Posted:	May 11, 2011
Last Update Posted:	December 14, 2016
Last Verified:	July 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Additional relevant MeSH terms:

Pre-Eclampsia; Eclampsia; Premature Birth; Fetal Growth Retardation; Placental Insufficiency; Hypertension, Pregnancy-Induced; Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Fetal Diseases; Growth Disorders; Pathologic Processes; Placenta Diseases; Aspirin; Anti-Inflammatory Agents, Non-Steroidal	Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Antipyretics