Aspirin for the Prevention of Preeclampsia and Pregnancy Outcomes After Assisted Reproductive Technology
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Toulouse
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Major fetal abnormality
Regular treatment with aspirin (including antiphospholipid syndrome)
Aspirin contraindications (allergy, von Willebrand disease, peptic ulceration, hemophilia)
Women protected by law.
Trial design
Design model
Parallel
Treatments tested in this trial
Aspirin
DrugExperimental drug administrated orally
Placebo
DrugTreatment for the control group
Treatment groups
1,164 Participants
are divided into 2 treatment groupsGroup A: AspirinExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Effect of aspirin 150mg daily initiated between 9 and 14 weeks of gestation versus placebo in the prevention of preterm (<37 weeks of gestation) preeclampsia
Occurrence of preterm (\<37 weeks of gestation) preeclampsia (binary variable yes/no)
Time frame
Up to 9 monthsSecondary outcomes
1
Compare the effect of aspirin 150mg daily initiated between 9 and 14 weeks of gestation versus placebo on spontaneous and total preterm birth <34 weeks of gestation
Occurrence of spontaneous and total preterm birth (defined by delivery at \<34 weeks of gestation)
Time frame
Up to 8 months2
Compare the effect of aspirin 150mg daily initiated between 9 and 14 weeks of gestation versus placebo on spontaneous and total preterm birth <37 weeks of gestation
Occurrence of spontaneous and total preterm birth (defined by delivery at \<37weeks of gestation)
Time frame
Up to 9 months3
Compare the effect of aspirin 150mg daily initiated between 9 and 14 weeks of gestation versus placebo on occurrence of preeclampsia <34 weeks of gestation, term preeclampsia (≥ 37 weeks of gestation)
Occurrence of term (≥37 weeks) preeclampsia
Time frame
Up to 8 months4
Compare the effect of aspirin 150mg daily initiated between 9 and 14 weeks of gestation versus placebo on occurrence of cesarean delivery
Occurrence of cesarean delivery
Time frame
Up to 9 monthsSponsors and contacts
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Source ClinicalTrials.gov