RecruitingPhase 3NCT05625724
Aspirin for the Prevention of Preeclampsia and Pregnancy Outcomes After Assisted Reproductive Technology
Aspirin for the Prevention of Preeclampsia and Pregnancy Outcomes in Nulliparous Women After Assisted Reproductive Technology. APPART
Sponsor
University Hospital, Toulouse
Enrollment
1,164 participants
Start Date
Aug 2, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
This study seeks to validate the hypothesis that nulliparous pregnant women after Assisted Reproductive Technology (ART) are at high risk of preeclampsia and perinatal complications and represent a subgroup for which aspirin prophylaxis during pregnancy may be effective in the prevention of preterm preeclampsia and other perinatal adverse outcomes.
Eligibility
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria6
- 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 Criteria5
- 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.
Interventions
DRUGAspirin
Experimental drug administrated orally
DRUGPlacebo
Treatment for the control group
Locations(21)
View Full Details on ClinicalTrials.gov
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NCT05625724
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