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

Phase 4

Completed

• Conditions: Pre-eclampsia; Intra-uterine Growth Restriction
• Interventions: Drug: Aspirin; Drug: Placebo

• Registration Number: NCT01729468
• Lead Sponsor: University Hospital, Tours

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-27
• Study First Submitted: 2012-11-02
• Study First Submitted QC: 2012-11-14
• Study First Posted: 2012-11-20
• Primary Completion: 2016-10-25
• Study Completion: 2016-10-25
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-16
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspirin	Aspirin	Aspirin 160 mg per day
Placebo	Placebo	Placebo 160 mg per day

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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
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

Trial Locations

Locations (17)

Service de Gynécologie-Obstétrique, HFME, Hospices Civils de Lyon; 🇫🇷 Bron, France

Service de gynécologie-obstétrique, Polyclinique du PARC; 🇫🇷 Caen, France

Service de Gynécologie-Obstétrique, Hôpital d'Estaing, CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Service de gynécologie-obstétrique, Hôpital Couple Enfant, CHRU de Grenoble; 🇫🇷 Grenoble, France

Cabinet Mosaïque Santé; 🇫🇷 La Chaussée St Victor, France

Service de gynécologie-obstétrique, CHR Le Mans; 🇫🇷 Le Mans, France

Service de Gyénécologie-Obstétrique, Hôpital Jeanne de Flandre, CHRU de Lille; 🇫🇷 Lille, France

Service de gynécologie-obstétrique, Hôpital Mère-Enfant, CHRU de Nantes; 🇫🇷 Nantes, France

Service de Gynécologie-Obstétrique, Hôpital Arnaud de Villeneuve, CHRU de Montpellier; 🇫🇷 Montpellier, France

Service de Gynécologie-Obstétrique, Hôpital Carémeau, CHRU de Nîmes; 🇫🇷 Nîmes, France

Service de gynécologie-obstétrique, Polyclinique de l'Atlantique; 🇫🇷 Nantes, France

Service de Gynécologie-Obstétrique, Hôpital Porte Madeleine, CHR d'Orléans; 🇫🇷 Orléans, France

Service de Gynécologie-Obstétrique, Hôpital Paule de Viguier, CHU de Toulouse; 🇫🇷 Toulouse, France

Centre de dépistage PRIMA FACIE, Hôpital Necker, APHP; 🇫🇷 Paris, France

Service de gynécologie-obstétrique, Maison de la Femme de la Mère et de l'Enfant, CHU de Fort de France; 🇲🇶 Fort de France, Martinique

Service de Gynécologie-Obstetrique, Centre Olympe de Gouges, CHRU de Tours; 🇫🇷 Tours, France

Service de Gynécologie-Obstétrique, Groupe Hospitalier Pellegrin, CHRU de Bordeaux; 🇫🇷 Bordeaux, France