Actively Recruiting

Phase 3
Age: 18Years +
FEMALE
ID05625724

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

On this page

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Follow-up

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

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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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