Comparison of Doses of Acetylsalicylic Acid in Women With Previous History of Preeclampsia
Primary Purpose
Pre-Eclampsia, Fetal Growth Retardation, Premature Birth
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Acetylsalicylic Acid 160 mg
Acetylsalicylic Acid 80 mg
Sponsored by
About this trial
This is an interventional prevention trial for Pre-Eclampsia
Eligibility 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
Sites / Locations
- Centre Hospitalier Universitaire de Québec (CHUQ)/Pavillon CHUL
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
Acetylsalicylic Acid 160mg administered at bedtime
Acetylsalicylic Acid 80mg administered at bedtime
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Rates of pregnancy complications related to placental insufficiency (preeclampsia, IUGR, premature birth)
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.
Full Information
NCT ID
NCT01352234
First Posted
April 1, 2011
Last Updated
November 8, 2018
Sponsor
CHU de Quebec-Universite Laval
1. Study Identification
Unique Protocol Identification Number
NCT01352234
Brief Title
Comparison of Doses of Acetylsalicylic Acid in Women With Previous History of Preeclampsia
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 Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Quebec-Universite Laval
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Eclampsia, Fetal Growth Retardation, Premature Birth, Placental Insufficiency
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Acetylsalicylic Acid 160mg administered at bedtime
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Acetylsalicylic Acid 80mg administered at bedtime
Intervention Type
Drug
Intervention Name(s)
Acetylsalicylic Acid 160 mg
Other Intervention Name(s)
Asaphen, Aspirin, ASA
Intervention Description
Capsule containing Acetylsalicylic Acid 160mg pill with lactose
Intervention Type
Drug
Intervention Name(s)
Acetylsalicylic Acid 80 mg
Other Intervention Name(s)
Asaphen, Aspirin, ASA
Intervention Description
Capsule containing Acetylsalicylic Acid 80mg pill with lactose
Primary Outcome Measure Information:
Title
Placental function
Description
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
Time Frame
22nd week of gestation
Secondary Outcome Measure Information:
Title
Rates of pregnancy complications related to placental insufficiency (preeclampsia, IUGR, premature birth)
Description
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.
Time Frame
At delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel Bujold, MD, MSc
Organizational Affiliation
CHU de Quebec-Universite Laval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Québec (CHUQ)/Pavillon CHUL
City
Québec
ZIP/Postal Code
G1V 4G2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Comparison of Doses of Acetylsalicylic Acid in Women With Previous History of Preeclampsia
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