Prevention of Pre-eclampsia and SGA by Low-Dose Aspirin in Nulliparous Women With Abnormal First-trimester Uterine Artery Dopplers

Study Overview
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Brief Summary
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The objective of this study is to test the efficacy of low-dose aspirin (160 mg/day), given bedtime and started early during pregnancy (≤ 15 +6 weeks of gestation) in nulliparous pregnant women selected as high-risk by the presence of a bilateral uterine artery notch and/or bilateral uterine artery PI ≥ 1.7 during the first trimester ultrasound scan (11-13+6 weeks), to prevent the occurrence of pre-eclampsia or small for gestational age at birth.

Official Title
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Prevention of Pre-eclampsia and SGA by Low-Dose Aspirin in Nulliparous Women With Abnormal First-trimester Uterine Artery Dopplers

Conditions
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Pre-eclampsia, Intra-uterine Growth Restriction

Intervention / Treatment
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* Drug: Aspirin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Nulliparous (no previous pregnancy ≥ 22 SA) Singleton pregnancy Gestational age ≤ 15 +6 weeks Bilateral uterine artery notch (grade ≥ 2) and/or bilateral uterine artery PI ≥ 1.7 during first trimester ultrasound (CRL between 45 and 84 mm) Maternal informed consent obtained Affiliated to social security system Exclusion Criteria: Women considering voluntary pregnancy termination (≤ 14 weeks) Pre-existing (maternal) indication for premature delivery before 37 weeks Fetal condition detected during the first trimester scan (fetal malformation or nuchal translucency ≥ 95th percentile) Women under anticoagulation Allergy or hypersensitivity to Kardegic® or one of its constituents Secondary hemostasis disorder responsible for bleeding or risk of bleeding Peptic ulcer under evolution Lupus or antiphospholipid syndrome

Ages Eligible for Study
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Minimum Age: 18 Months

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aspirin<br>Aspirin 160 mg per day | Drug: Aspirin<br>* Aspirin, 160 mg per day until 34 weeks of gestation<br>|
| Placebo Comparator: Placebo<br>Placebo 160 mg per day | Drug: Placebo<br>* Placebo, 160 mg per day until 34 weeks of gestation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preeclampsia (diagnosed per ACOG criteria) and small for gestational age at birth (≤5th percentile on customized growth curves) |  | women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Small for gestational age at birth (≤5th percentile on customized growth curves) |  | women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks | 
| Pre-eclampsia (ACOG criteria) requiring delivery before 34 weeks |  | women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks | 
| Severe pre-eclampsia (ACOG criteria) |  | women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks | 
| Perinatal death (22 weeks of gestation to 7 days postnatal) |  | women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks | 
| Pre-eclampsia (ACOG criteria) |  | women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks | 
| Adverse effects of treatment |  | women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Low Dose Acetylsalicylic Acid, Pre-eclampsia, Intra-uterine Growth Restriction, Primiparous Women, Bilateral Uterine Artery Notches, First Quarter