Using aspirin to prevent preeclampsia in women after assisted reproductive technology
Aspirin for the Prevention of Preeclampsia and Pregnancy Outcomes in Nulliparous Women After Assisted Reproductive Technology. APPART
PHASE3 · University Hospital, Toulouse · NCT05625724
This study is testing if taking aspirin during early pregnancy can help prevent preeclampsia in women who are at high risk and became pregnant through assisted reproductive technology.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1164 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Toulouse (other) |
| Locations | 21 sites (Angers and 20 other locations) |
| Trial ID | NCT05625724 on ClinicalTrials.gov |
What this trial studies
This study aims to determine if aspirin can effectively prevent preeclampsia and improve pregnancy outcomes in nulliparous women who conceive through assisted reproductive technology (ART). It focuses on women who are at high risk for preeclampsia and examines the efficacy of aspirin prophylaxis when administered during early pregnancy. The study will compare outcomes between those receiving aspirin and those receiving a placebo, with a particular emphasis on identifying high-risk patients who could benefit from this treatment. The research is set in France, where current guidelines restrict aspirin use to women with specific risk factors, potentially overlooking others who may also benefit.
Who should consider this trial
Good fit: Ideal candidates for this study are nulliparous women aged 18 and older who are pregnant following assisted reproductive technology and are between 9 and 14 weeks of gestation.
Not a fit: Patients with major fetal abnormalities, those regularly taking aspirin, or those with contraindications to aspirin will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention of preeclampsia and better pregnancy outcomes for women who conceive through ART.
How similar studies have performed: Other studies have shown promising results for aspirin in preventing preeclampsia in high-risk populations, but this specific approach in ART patients is less explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Nulliparous women aged 18 years or more * Pregnancy following ART, including in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI), oocyte donation or intrauterine insemination with sperm donor * Singleton pregnancy * Evolutive pregnancy between 9 and 14 weeks of gestation * Women affiliated to a French Social Security Insurance or equivalent social protection * Written informed consent Exclusion Criteria: * Major fetal abnormality * Regular treatment with aspirin (including antiphospholipid syndrome) * Aspirin contraindications (allergy, von Willebrand disease, peptic ulceration, hemophilia) * Women protected by law. * Women included in another interventional study.
Where this trial is running
Angers and 20 other locations
- CHU Angers — Angers, France (RECRUITING)
- CHU Bordeaux — Bordeaux, France (RECRUITING)
- CHU Clermont-Ferrand — Clermont-Ferrand, France (RECRUITING)
- CHU Dijon-Bourgogne — Dijon, France (RECRUITING)
- CHU Lille — Lille, France (RECRUITING)
- HCL - Groupement Hospitalier Est, Hôpital Femme Mère Enfant — Lyon, France (RECRUITING)
- AP-HM Hôpital de la Conception — Marseille, France (RECRUITING)
- AP-HM Hôpital Nord — Marseille, France (RECRUITING)
- CHU Montpellier — Montpellier, France (RECRUITING)
- CHRU Nancy — Nancy, France (RECRUITING)
- CHU Nantes — Nantes, France (RECRUITING)
- CHU Nîmes — Nîmes, France (RECRUITING)
- Groupe hospitalier St Joseph — Paris, France (RECRUITING)
- Hôpital Armand - Trousseau — Paris, France (NOT_YET_RECRUITING)
- Hôpital Cochin — Paris, France (RECRUITING)
- CHI Poissy Saint Germain en Laye — Poissy, France (RECRUITING)
- CHU Poitiers — Poitiers, France (NOT_YET_RECRUITING)
- CHU Rennes — Rennes, France (RECRUITING)
- CHU Saint Etienne, Hôpital Nord — Saint-Etienne, France (RECRUITING)
- CHU Strasbourg — Strasbourg, France (RECRUITING)
- CHU Toulouse — Toulouse, France (RECRUITING)
Study contacts
- Principal investigator: Christophe VAYSSIERE, MD — University Hospital, Toulouse
- Study coordinator: Paul GUERBY, MD
- Email: guerby.p@chu-toulouse.fr
- Phone: 5 67 77 12 33
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: ART, Pre-Eclampsia