Premature Birth Clinical Trial
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
Verified date | November 2018 |
Source | CHU de Quebec-Universite Laval |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 104 |
Est. completion date | March 2015 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Centre Hospitalier Universitaire de Québec (CHUQ)/Pavillon CHUL | Québec |
Lead Sponsor | Collaborator |
---|---|
CHU de Quebec-Universite Laval |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | At delivery |
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