MedDataX Logo

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

NCT ID: NCT01729468

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-27

Study Completion Date

2016-10-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pre-eclampsia Intra-uterine Growth Restriction

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Low Dose Acetylsalicylic Acid Prevention Pre-eclampsia Intra-uterine Growth Restriction Primiparous Women Bilateral Uterine Artery Notches First Quarter

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Aspirin

Aspirin 160 mg per day

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

Aspirin, 160 mg per day until 34 weeks of gestation

Placebo

Placebo 160 mg per day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, 160 mg per day until 34 weeks of gestation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Aspirin

Aspirin, 160 mg per day until 34 weeks of gestation

Intervention Type DRUG

Placebo

Placebo, 160 mg per day until 34 weeks of gestation

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Months

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Franck PERROTIN, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Tours

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Service de Gynécologie-Obstétrique, Groupe Hospitalier Pellegrin, CHRU de Bordeaux

Bordeaux, , France

Site Status

Service de Gynécologie-Obstétrique, HFME, Hospices Civils de Lyon

Bron, , France

Site Status

Service de gynécologie-obstétrique, Polyclinique du PARC

Caen, , France

Site Status

Service de Gynécologie-Obstétrique, Hôpital d'Estaing, CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Service de gynécologie-obstétrique, Hôpital Couple Enfant, CHRU de Grenoble

Grenoble, , France

Site Status

Cabinet Mosaïque Santé

La Chaussée-Saint-Victor, , France

Site Status

Service de gynécologie-obstétrique, CHR Le Mans

Le Mans, , France

Site Status

Service de Gyénécologie-Obstétrique, Hôpital Jeanne de Flandre, CHRU de Lille

Lille, , France

Site Status

Service de Gynécologie-Obstétrique, Hôpital Arnaud de Villeneuve, CHRU de Montpellier

Montpellier, , France

Site Status

Service de gynécologie-obstétrique, Hôpital Mère-Enfant, CHRU de Nantes

Nantes, , France

Site Status

Service de gynécologie-obstétrique, Polyclinique de l'Atlantique

Nantes, , France

Site Status

Service de Gynécologie-Obstétrique, Hôpital Carémeau, CHRU de Nîmes

Nîmes, , France

Site Status

Service de Gynécologie-Obstétrique, Hôpital Porte Madeleine, CHR d'Orléans

Orléans, , France

Site Status

Centre de dépistage PRIMA FACIE, Hôpital Necker, APHP

Paris, , France

Site Status

Service de Gynécologie-Obstétrique, Hôpital Paule de Viguier, CHU de Toulouse

Toulouse, , France

Site Status

Service de Gynécologie-Obstetrique, Centre Olympe de Gouges, CHRU de Tours

Tours, , France

Site Status

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

Fort-de-France, , Martinique

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France Martinique

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 22986844 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23004922 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18634131 (View on PubMed)

Diguisto C, Le Gouge A, Marchand MS, Megier P, Ville Y, Haddad G, Winer N, Arthuis C, Doret M, Debarge VH, Flandrin A, Delmas HL, Gallot D, Mares P, Vayssiere C, Sentilhes L, Cheve MT, Paumier A, Durin L, Schaub B, Equy V, Giraudeau B, Perrotin F; Groupe de Recherche en Obstetrique et Gynecologie (GROG). Low-dose aspirin to prevent preeclampsia and growth restriction in nulliparous women identified by uterine artery Doppler as at high risk of preeclampsia: A double blinded randomized placebo-controlled trial. PLoS One. 2022 Oct 19;17(10):e0275129. doi: 10.1371/journal.pone.0275129. eCollection 2022.

Reference Type RESULT
PMID: 36260615 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PHRN08-FP/PERASTUN

Identifier Type: -

Identifier Source: org_study_id

2011-003536-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2012-R8

Identifier Type: OTHER

Identifier Source: secondary_id

A120316-72

Identifier Type: OTHER

Identifier Source: secondary_id

912140

Identifier Type: OTHER

Identifier Source: secondary_id