Clinical trial NCT01729468: Prevention of Pre-eclampsia and SGA by Low-Dose Aspirin in Nulliparous Women With Abnormal First-trimester Uterine Artery Dopplers
Official title: Prevention of Pre-eclampsia and SGA by Low-Dose Aspirin in Nulliparous Women With Abnormal First-trimester Uterine Artery Dopplers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pre-eclampsia
Intra-uterine Growth Restriction
Keywords: Low Dose Acetylsalicylic Acid
Prevention
Pre-eclampsia
Intra-uterine Growth Restriction
Primiparous Women
Bilateral Uterine Artery Notches
First Quarter
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2012-11-20
Enrollment: 1106
Sex: FEMALE
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Preeclampsia (diagnosed per ACOG criteria) and small for gestational age at birth (≤5th percentile on customized growth curves)
timeFrame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Secondary outcomes:
measure: Small for gestational age at birth (≤5th percentile on customized growth curves)
timeFrame: women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks
measure: Pre-eclampsia (ACOG criteria) requiring delivery before 34 weeks
timeFrame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
measure: Severe pre-eclampsia (ACOG criteria)
timeFrame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
measure: Perinatal death (22 weeks of gestation to 7 days postnatal)
timeFrame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
measure: Pre-eclampsia (ACOG criteria)
timeFrame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
measure: Adverse effects of treatment
timeFrame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Other outcomes:
measure: Mode of delivery (vaginal or cesarean)
timeFrame: women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks
measure: Mode of anesthesia for delivery
timeFrame: women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks
Locations:
city: Bordeaux
country: France
facility: Service de Gynécologie-Obstétrique, Groupe Hospitalier Pellegrin, CHRU de Bordeaux
city: Bron
country: France
facility: Service de Gynécologie-Obstétrique, HFME, Hospices Civils de Lyon
city: Caen
country: France
facility: Service de gynécologie-obstétrique, Polyclinique du PARC
city: Clermont-Ferrand
country: France
facility: Service de Gynécologie-Obstétrique, Hôpital d'Estaing, CHU de Clermont-Ferrand
city: Grenoble
country: France
facility: Service de gynécologie-obstétrique, Hôpital Couple Enfant, CHRU de Grenoble
city: La Chaussée St Victor
country: France
facility: Cabinet Mosaïque Santé
city: Le Mans
country: France
facility: Service de gynécologie-obstétrique, CHR Le Mans
city: Lille
country: France
facility: Service de Gyénécologie-Obstétrique, Hôpital Jeanne de Flandre, CHRU de Lille
city: Montpellier
country: France
facility: Service de Gynécologie-Obstétrique, Hôpital Arnaud de Villeneuve, CHRU de Montpellier
city: Nantes
country: France
facility: Service de gynécologie-obstétrique, Hôpital Mère-Enfant, CHRU de Nantes
city: Nantes
country: France
facility: Service de gynécologie-obstétrique, Polyclinique de l'Atlantique
city: Nîmes
country: France
facility: Service de Gynécologie-Obstétrique, Hôpital Carémeau, CHRU de Nîmes
city: Orléans
country: France
facility: Service de Gynécologie-Obstétrique, Hôpital Porte Madeleine, CHR d'Orléans
city: Paris
country: France
facility: Centre de dépistage PRIMA FACIE, Hôpital Necker, APHP
city: Toulouse
country: France
facility: Service de Gynécologie-Obstétrique, Hôpital Paule de Viguier, CHU de Toulouse
city: Tours
country: France
facility: Service de Gynécologie-Obstetrique, Centre Olympe de Gouges, CHRU de Tours
city: Fort de France
country: Martinique
facility: Service de gynécologie-obstétrique, Maison de la Femme de la Mère et de l'Enfant, CHU de Fort de France
Study officials:
affiliation: University Hospital, Tours
name: Franck PERROTIN, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Poon LC, Syngelaki A, Akolekar R, Lai J, Nicolaides KH. Combined screening for preeclampsia and small for gestational age at 11-13 weeks. Fetal Diagn Ther. 2013;33(1):16-27. doi: 10.1159/000341712. Epub 2012 Sep 13.
citation: Ayala DE, Ucieda R, Hermida RC. Chronotherapy with low-dose aspirin for prevention of complications in pregnancy. Chronobiol Int. 2013 Mar;30(1-2):260-79. doi: 10.3109/07420528.2012.717455. Epub 2012 Sep 24.
citation: Plasencia W, Maiz N, Poon L, Yu C, Nicolaides KH. Uterine artery Doppler at 11 + 0 to 13 + 6 weeks and 21 + 0 to 24 + 6 weeks in the prediction of pre-eclampsia. Ultrasound Obstet Gynecol. 2008 Aug;32(2):138-46. doi: 10.1002/uog.5402.