ARTPhase 3APPARTNCT05625724
Aspirin for the Prevention of Preeclampsia and Pregnancy Outcomes After Assisted Reproductive Technology
A Phase 3 study testing Aspirin in people with ART and Pre-Eclampsia, run by University Hospital, Toulouse at 21 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- ART, Pre-Eclampsia
- What is being tested?
- Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,164 participants
- Where
- 21 sitesFrance
- Study dates
- 2 Aug 2023to May 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
France21 sites, 21 recruiting
- Recruiting
CHU Angers
Angers
Pierre-Emmanuel BOUET, MD
Pierre-Emmanuel BOUET
- Recruiting
CHU Bordeaux
Bordeaux
Loic Sentilhes, MD
Loic SENTILHES
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand
Amélie DELABAERE, MD
Amélie DELABAERE
- Recruiting
CHU Dijon-Bourgogne
Dijon
Emmanuel Simon, MD
Emmanuel SIMON
- Recruiting
CHU Lille
Lille
Véronique Debarge, MD
Véronique DEBARGE
- Recruiting
HCL - Groupement Hospitalier Est, Hôpital Femme Mère Enfant
Lyon
Mona Massoud, MD
Mona MASSOUD
- Recruiting
AP-HM Hôpital de la Conception
Marseille
Blandine Courbière, MD
Blandine COURBIERE
- Recruiting
AP-HM Hôpital Nord
Marseille
Julie Blanc, MD
Julie BLANC
- Recruiting
CHU Montpellier
Montpellier
Noémie Ranisavljevic, MD
Noémie RANISAVLJEVIC
- Recruiting
CHRU Nancy
Nancy
Catherine Zuili Lamy, MD
Catherine ZUILI LAMY
- Recruiting
CHU Nantes
Nantes
Vincent Dochez, MD
Vincent DOCHEZ
- Recruiting
CHU Nîmes
Nîmes
Stéphanie Huberlant, MD
Stéphanie HUBERLANT
- Recruiting
Groupe hospitalier St Joseph
Paris
Elie Azria, MD
Elie AZRIA
- Not yet recruiting
Hôpital Armand - Trousseau
Paris
Gilles Kayem, MD
Gilles KAYEM
- Recruiting
Hôpital Cochin
Paris
Vassilis Tsatsaris, MD
Vassilis TSATSARIS
- Recruiting
CHI Poissy Saint Germain en Laye
Poissy
Paul Berveiller, MD
Paul BERVEILLER
- Not yet recruiting
CHU Poitiers
Poitiers
Aurélie Brossard Violeau, MD
Aurélie BROSSARD VIOLEAU
- Recruiting
CHU Rennes
Rennes
Céline Pimentel, MD
Céline PIMENTEL
- Recruiting
CHU Saint Etienne, Hôpital Nord
Saint-Etienne
Tiphaine Barjat, MD
Tiphaine BARJAT
- Recruiting
CHU Strasbourg
Strasbourg
Catherine Rongières, MD
Catherine RONGIERE
- Recruiting
CHU Toulouse
Toulouse
Paul GUERBY, MD, guerby.p@chu-toulouse.fr
Christophe VAYSSIERE, MD
About this study
Official title: Aspirin for the Prevention of Preeclampsia and Pregnancy Outcomes in Nulliparous Women After Assisted Reproductive Technology. APPART
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.
Read the detailed description
Preeclampsia (PE) affects 2% of pregnancies in France and is an important cause of maternal and perinatal mortality and morbidity. Aspirin is currently the only prophylactic therapy for PE in high-risk women when initiated before 16 weeks of gestation and at a daily dose of 100-160 mg, with a reduction in the incidence of preterm preeclampsia of 60-70% in recent meta-analysis. Latest data also demonstrate a potential beneficial effect of aspirin on spontaneous preterm birth. A major challenge in modern obstetrics is early identification of pregnant women at high-risk of PE who could benefit from aspirin treatment. In France, the College National des Gynécologues et Obstétriciens Français and the Société Française d'HyperTension Artérielle have restrictive recommendation of aspirin to be prescribed only to women with a history of PE or vascular intra-uterine growth restriction, thus leaving out all nulliparous women (including those with multiple risk factors). Other countries (USA, United Kingdom (UK), Canada) have much broader recommendations with aspirin prescription for patients with one high or 2 moderate risk factors, but exposing nearly 30% of pregnant women to aspirin (leading to unnecessary exposure to treatment). The Fetal Medicine Foundation provides a screening test combining clinical parameters, uterine artery Doppler, and biomarkers; but this strategy has high false-positive rate and the reproducibility needs to be confirmed in clinical practice.
It seems necessary to be able to better target women at risk, especially in nulliparous women. Nulliparity and assisted reproductive technology (ART) are independent risk factors for PE. Currently the proportion of pregnancy after ART in France is roughly 6.9% and is rising. Nulliparous ART pregnant women have a higher risk of PE and preterm birth. Indeed, they commonly cumulate risk factors including age>35years in association with nulliparity and ART. The rate of PE in this population can rise up to 10%.
Our hypothesis is that nulliparous pregnant women after 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.
- Conditions
- ART, Pre-Eclampsia
- Being tested
- Aspirin, Placebo
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Experimental drug administrated orally
PlaceboDrug
Treatment for the control group
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Experimental | Low-dose Aspirin: 150mg, daily, oral route, at bedtime, initiated between 9 and 14 weeks of gestation, until 35 (+6) weeks of gestation, or in the event of earlier delivery, until the onset of labor. Receives: Drug: Aspirin |
| Control | Placebo comparator | Matching placebo administrated daily, oral route, at bedtime, initiated between 9 and 14 weeks of gestation, until 35 (+6) weeks of gestation, or in the event of earlier delivery, until the onset of labor. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 9 months
Secondary outcomes (7)
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)
Measured: Up to 8 months
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)
Measured: Up to 9 months
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
Measured: Up to 8 months
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
Measured: Up to 9 months
Compare the effect of aspirin 150mg daily initiated between 9 and 14 weeks of gestation versus placebo on occurrence of postpartum hemorrhage (>500ml)
Occurrence of postpartum hemorrhage (>500ml)
Measured: Up to 9 months
Compare the effect of aspirin 150mg daily initiated between 9 and 14 weeks of gestation versus placebo on occurrence of placental abruption
Occurrence of placental abruption
Measured: Up to 9 months
Compare the effect of aspirin 150mg daily initiated between 9 and 14 weeks of gestation versus placebo on neonatal adverse outcome.
Occurrence of neonatal adverse outcomes: still birth, neonatal death, neonatal complications
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start2 Aug 2023
- Primary completionAug 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARTStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe VAYSSIERE, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625724
- Sponsor's protocol ID
- RC31/21/0337
- Acronym
- APPART
- Status last verified
- May 2026
- First submitted
- 14 Nov 2022
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin for the Prevention of Preeclampsia and Pregnancy Outcomes in Nulliparous Women After Assisted Reproductive Technology. APPART
- ClinicalTrials.gov ID
- NCT05625724
- Acronym / sponsor ID
- APPART / RC31/21/0337
- Conditions
- ART, Pre-Eclampsia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,164 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 23 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Preeclampsia (PE) affects 2% of pregnancies in France and is an important cause of maternal and perinatal mortality and morbidity. Aspirin is currently the only prophylactic therapy for PE in high-risk women when initiated before 16 weeks of gestation and at a daily dose of 100-160 mg, with a reduction in the incidence of preterm preeclampsia of 60-70% in recent meta-analysis. Latest data also demonstrate a potential beneficial effect of aspirin on spontaneous preterm birth. A major challenge in modern obstetrics is early identification of pregnant women at high-risk of PE who could benefit from aspirin treatment. In France, the College National des Gynécologues et Obstétriciens Français and the Société Française d'HyperTension Artérielle have restrictive recommendation of aspirin to be prescribed only to women with a history of PE or vascular intra-uterine growth restriction, thus leaving out all nulliparous women (including those with multiple risk factors). Other countries (USA, United Kingdom (UK), Canada) have much broader recommendations with aspirin prescription for patients with one high or 2 moderate risk factors, but exposing nearly 30% of pregnant women to aspirin (leading to unnecessary exposure to treatment). The Fetal Medicine Foundation provides a screening test combining clinical parameters, uterine artery Doppler, and biomarkers; but this strategy has high false-positive rate and the reproducibility needs to be confirmed in clinical practice.
It seems necessary to be able to better target women at risk, especially in nulliparous women. Nulliparity and assisted reproductive technology (ART) are independent risk factors for PE. Currently the proportion of pregnancy after ART in France is roughly 6.9% and is rising. Nulliparous ART pregnant women have a higher risk of PE and preterm birth. Indeed, they commonly cumulate risk factors including age>35years in association with nulliparity and ART. The rate of PE in this population can rise up to 10%.
Our hypothesis is that nulliparous pregnant women after 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Experimental | Drug: AspirinLow-dose Aspirin: 150mg, daily, oral route, at bedtime, initiated between 9 and 14 weeks of gestation, until 35 (+6) weeks of gestation, or in the event of earlier delivery, until the onset of labor. |
| Control | Placebo comparator | Drug: PlaceboMatching placebo administrated daily, oral route, at bedtime, initiated between 9 and 14 weeks of gestation, until 35 (+6) weeks of gestation, or in the event of earlier delivery, until the onset of labor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinExperimental drug administrated orally | Drug | Aspirin |
| PlaceboTreatment for the control group | Drug | Control |
Primary outcome
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
Time frame: Up to 9 months
Occurrence of preterm (<37 weeks of gestation) preeclampsia (binary variable yes/no)
7 secondary outcomes
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
Time frame: Up to 8 months
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
Time frame: Up to 9 months
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)
Time frame: Up to 8 months
Compare the effect of aspirin 150mg daily initiated between 9 and 14 weeks of gestation versus placebo on occurrence of cesarean delivery
Time frame: Up to 9 months
Compare the effect of aspirin 150mg daily initiated between 9 and 14 weeks of gestation versus placebo on occurrence of postpartum hemorrhage (>500ml)
Time frame: Up to 9 months
Compare the effect of aspirin 150mg daily initiated between 9 and 14 weeks of gestation versus placebo on occurrence of placental abruption
Time frame: Up to 9 months
Compare the effect of aspirin 150mg daily initiated between 9 and 14 weeks of gestation versus placebo on neonatal adverse outcome.
Time frame: Up to 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christophe VAYSSIERE, MD principal investigator
University Hospital, Toulouse
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aspirin in people with ART and Pre-Eclampsia, run by University Hospital, Toulouse at 21 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul GUERBY, MD (5 67 77 12 33, guerby.p@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Up to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.