Actively Recruiting
Aspirin for the Prevention of Preeclampsia and Pregnancy Outcomes in Nulliparous Women After Assisted Reproductive Technology (APPART)
Led by University Hospital, Toulouse · Updated on 2026-05-07
1164
Participants Needed
21
Research Sites
39 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying nulliparous pregnant women who have conceived through Assisted Reproductive Technology (ART) to evaluate if aspirin can help prevent preterm preeclampsia and related pregnancy complications. This group is considered at higher risk for preeclampsia and perinatal issues, with a current rate of preeclampsia up to 10%. The study aims to determine if aspirin given during pregnancy reduces these risks in this specific population. Participants are randomly assigned to receive either a daily oral dose of 150 mg low-dose aspirin or a matching placebo. Treatment starts between 9 and 14 weeks of pregnancy and continues until 35 weeks and 6 days of gestation or until labor begins. The study compares outcomes between these two groups to assess the effects of aspirin. During the trial, participants will be monitored for the development of preterm preeclampsia before 37 weeks of gestation and other pregnancy outcomes such as preterm birth, cesarean delivery, postpartum hemorrhage, placental abruption, and neonatal adverse events. The study will last up to 9 months, covering the pregnancy period, with data collected to evaluate the aspirin's impact on these health measures.
CONDITIONS
Brief Title
Aspirin for the Prevention of Preeclampsia and Pregnancy Outcomes After Assisted Reproductive Technology
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Nulliparous women aged 18 years or more
- Pregnancy following Assisted Reproductive Technology, including IVF, ICSI, oocyte donation, or intrauterine insemination with sperm donor
- Singleton pregnancy
- Evolving pregnancy between 9 and 14 weeks of gestation
- Women affiliated with French Social Security Insurance or equivalent
- Written informed consent
You will not qualify if you...
- Major fetal abnormality
- Regular treatment with aspirin (including for antiphospholipid syndrome)
- Allergy to aspirin or contraindications such as von Willebrand disease, peptic ulceration, or hemophilia
- Women protected by law
- Participation in another interventional study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From 9-14 weeks to 35 (+6) weeks of gestation or until labor
Participants take low-dose aspirin or placebo daily at bedtime starting between 9 and 14 weeks of gestation until 35 weeks plus 6 days of gestation or until the onset of labor in case of earlier delivery.
Regular visits as per clinical care (visit frequency not specified)
Duration - Up to 9 months until delivery
Participants are monitored for pregnancy outcomes including preterm preeclampsia, preterm birth, cesarean delivery, postpartum hemorrhage, placental abruption, and neonatal adverse outcomes until delivery.
Visits aligned with pregnancy assessments (visit frequency not specified)
Trial Site Locations
Total: 21 locations
1
CHU Angers
Angers, France
Actively Recruiting
2
CHU Bordeaux
Bordeaux, France
Actively Recruiting
3
CHU Clermont-Ferrand
Clermont-Ferrand, France
Actively Recruiting
4
CHU Dijon-Bourgogne
Dijon, France
Actively Recruiting
5
CHU Lille
Lille, France
Actively Recruiting
6
HCL - Groupement Hospitalier Est, Hôpital Femme Mère Enfant
Lyon, France
Actively Recruiting
7
AP-HM Hôpital de la Conception
Marseille, France
Actively Recruiting
8
AP-HM Hôpital Nord
Marseille, France
Actively Recruiting
9
CHU Montpellier
Montpellier, France
Actively Recruiting
10
CHRU Nancy
Nancy, France
Actively Recruiting
11
CHU Nantes
Nantes, France
Actively Recruiting
12
CHU Nîmes
Nîmes, France
Actively Recruiting
13
Groupe hospitalier St Joseph
Paris, France
Actively Recruiting
14
Hôpital Armand - Trousseau
Paris, France
Not Yet Recruiting
15
Hôpital Cochin
Paris, France
Actively Recruiting
16
CHI Poissy Saint Germain en Laye
Poissy, France
Actively Recruiting
17
CHU Poitiers
Poitiers, France
Not Yet Recruiting
18
CHU Rennes
Rennes, France
Actively Recruiting
19
CHU Saint Etienne, Hôpital Nord
Saint-Etienne, France
Actively Recruiting
20
CHU Strasbourg
Strasbourg, France
Actively Recruiting
21
CHU Toulouse
Toulouse, France
Actively Recruiting
Research Team
P
Paul GUERBY, MD
D
Delphine DUCHANOIS, Midwife
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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