Pre-eclampsiaPhase 4PERASTUNNCT01729468
Prevention of Pre-eclampsia and SGA by Low-Dose Aspirin in Nulliparous Women With Abnormal First-trimester Uterine Artery Dopplers
A Phase 4 study testing Aspirin in people with Pre-eclampsia and Intra-uterine Growth Restriction, run by University Hospital, Tours at 17 sites in 2 countries.
Trial summary
The objective of this study is to test the efficacy of low-dose aspirin (160 mg/day), given bedtime and started early during pregnancy (≤ 15 +6 weeks of gestation) in nulliparous pregnant women selected as "high-risk" by the presence of a bilateral uterine artery notch and/or bilateral uterine artery PI ≥ 1.7 during… Read more about this study
- Who is it for?
- Ages 18 months and older, women only
- Conditions the study is for
- Pre-eclampsia, Intra-uterine Growth Restriction
- What is being tested?
- Aspirin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,106 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 27 Jun 2012to 25 Oct 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 months and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Nulliparous (no previous pregnancy ≥ 22 SA)
- Singleton pregnancy
- Gestational age ≤ 15 +6 weeks
- Bilateral uterine artery notch (grade ≥ 2) and/or bilateral uterine artery PI ≥ 1.7 during first trimester ultrasound (CRL between 45 and 84 mm)
- Maternal informed consent obtained
- Affiliated to social security system
Who cannot join
- Women considering voluntary pregnancy termination (≤ 14 weeks)
- Pre-existing (maternal) indication for premature delivery before 37 weeks
- Fetal condition detected during the first trimester scan (fetal malformation or nuchal translucency ≥ 95th percentile)
- Women under anticoagulation
- Allergy or hypersensitivity to Kardegic® or one of its constituents
- Secondary hemostasis disorder responsible for bleeding or risk of bleeding
- Peptic ulcer under evolution
- Lupus or antiphospholipid syndrome
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
France16 sites
Service de Gynécologie-Obstétrique, Groupe Hospitalier Pellegrin, CHRU de Bordeaux
Bordeaux, 33000
Service de Gynécologie-Obstétrique, HFME, Hospices Civils de Lyon
Bron, 69677
Service de gynécologie-obstétrique, Polyclinique du PARC
Caen, 14052
Service de Gynécologie-Obstétrique, Hôpital d'Estaing, CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
Service de gynécologie-obstétrique, Hôpital Couple Enfant, CHRU de Grenoble
Grenoble, 38043
Cabinet Mosaïque Santé
La Chaussée-Saint-Victor, 41260
Service de gynécologie-obstétrique, CHR Le Mans
Le Mans, 72037
Service de Gyénécologie-Obstétrique, Hôpital Jeanne de Flandre, CHRU de Lille
Lille, 59037
Service de Gynécologie-Obstétrique, Hôpital Arnaud de Villeneuve, CHRU de Montpellier
Montpellier, 34295
Service de gynécologie-obstétrique, Hôpital Mère-Enfant, CHRU de Nantes
Nantes, 44093
Service de gynécologie-obstétrique, Polyclinique de l'Atlantique
Nantes, 44819
Service de Gynécologie-Obstétrique, Hôpital Carémeau, CHRU de Nîmes
Nîmes, 30029
Service de Gynécologie-Obstétrique, Hôpital Porte Madeleine, CHR d'Orléans
Orléans, 45032
Centre de dépistage PRIMA FACIE, Hôpital Necker, APHP
Paris, 75014
Service de Gynécologie-Obstétrique, Hôpital Paule de Viguier, CHU de Toulouse
Toulouse, 31059
Service de Gynécologie-Obstetrique, Centre Olympe de Gouges, CHRU de Tours
Tours, 37044
Martinique1 site
Service de gynécologie-obstétrique, Maison de la Femme de la Mère et de l'Enfant, CHU de Fort de France
Fort-de-France, 97261
About this study
The objective of this study is to test the efficacy of low-dose aspirin (160 mg/day), given bedtime and started early during pregnancy (≤ 15 +6 weeks of gestation) in nulliparous pregnant women selected as "high-risk" by the presence of a bilateral uterine artery notch and/or bilateral uterine artery PI ≥ 1.7 during the first trimester ultrasound scan (11-13+6 weeks), to prevent the occurrence of pre-eclampsia or small for gestational age at birth.
- Conditions
- Pre-eclampsia, Intra-uterine Growth Restriction
- Being tested
- Aspirin, Placebo
- Keywords
- Low Dose Acetylsalicylic Acid, Prevention, Pre-eclampsia, Intra-uterine Growth Restriction, Primiparous Women, Bilateral Uterine Artery Notches, First Quarter
- 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
Aspirin, 160 mg per day until 34 weeks of gestation
PlaceboDrug
Placebo, 160 mg per day until 34 weeks of gestation
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Experimental | Aspirin 160 mg per day Receives: Drug: Aspirin |
| Placebo | Placebo comparator | Placebo 160 mg per day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preeclampsia (diagnosed per ACOG criteria) and small for gestational age at birth (≤5th percentile on customized growth curves)
Measured: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Secondary outcomes (6)
Small for gestational age at birth (≤5th percentile on customized growth curves)
Measured: women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks
Pre-eclampsia (ACOG criteria) requiring delivery before 34 weeks
Measured: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Severe pre-eclampsia (ACOG criteria)
Measured: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Perinatal death (22 weeks of gestation to 7 days postnatal)
Measured: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Pre-eclampsia (ACOG criteria)
Measured: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Adverse effects of treatment
Measured: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study start27 Jun 2012
- Primary completion25 Oct 2016
- Study completion25 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pre-eclampsiaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franck PERROTIN, MD-PhD, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729468
- Sponsor's protocol ID
- PHRN08-FP/PERASTUN
- Other IDs
- 2011-003536-30, 2012-R8, A120316-72, 912140
- Acronym
- PERASTUN
- Status last verified
- Dec 2025
- First submitted
- 2 Nov 2012
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Poon LC, Syngelaki A, Akolekar R, Lai J, Nicolaides KH. Combined screening for preeclampsia and small for gestational age at 11-13 weeks. Fetal Diagn Ther. 2013;33(1):16-27. doi: 10.1159/000341712. Epub 2012 Sep 13.
PubMed 22986844Ayala DE, Ucieda R, Hermida RC. Chronotherapy with low-dose aspirin for prevention of complications in pregnancy. Chronobiol Int. 2013 Mar;30(1-2):260-79. doi: 10.3109/07420528.2012.717455. Epub 2012 Sep 24.
PubMed 23004922Plasencia W, Maiz N, Poon L, Yu C, Nicolaides KH. Uterine artery Doppler at 11 + 0 to 13 + 6 weeks and 21 + 0 to 24 + 6 weeks in the prediction of pre-eclampsia. Ultrasound Obstet Gynecol. 2008 Aug;32(2):138-46. doi: 10.1002/uog.5402.
PubMed 18634131Diguisto C, Le Gouge A, Marchand MS, Megier P, Ville Y, Haddad G, Winer N, Arthuis C, Doret M, Debarge VH, Flandrin A, Delmas HL, Gallot D, Mares P, Vayssiere C, Sentilhes L, Cheve MT, Paumier A, Durin L, Schaub B, Equy V, Giraudeau B, Perrotin F; Groupe de Recherche en Obstetrique et Gynecologie (GROG). Low-dose aspirin to prevent preeclampsia and growth restriction in nulliparous women identified by uterine artery Doppler as at high risk of preeclampsia: A double blinded randomized placebo-controlled trial. PLoS One. 2022 Oct 19;17(10):e0275129. doi: 10.1371/journal.pone.0275129. eCollection 2022.
PubMed 36260615
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Pre-eclampsia and SGA by Low-Dose Aspirin in Nulliparous Women With Abnormal First-trimester Uterine Artery Dopplers
- ClinicalTrials.gov ID
- NCT01729468
- Acronym / sponsor ID
- PERASTUN / PHRN08-FP/PERASTUN
- Conditions
- Pre-eclampsia, Intra-uterine Growth Restriction
- Keywords
- Low Dose Acetylsalicylic Acid, Prevention, Pre-eclampsia, Intra-uterine Growth Restriction, Primiparous Women, Bilateral Uterine Artery Notches, First Quarter
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,106 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 27 Jun 2012 (actual)
- Primary completion
- 25 Oct 2016 (actual)
- Study completion
- 25 Oct 2016 (actual)
- First posted
- 20 Nov 2012 (estimated)
- 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.
The objective of this study is to test the efficacy of low-dose aspirin (160 mg/day), given bedtime and started early during pregnancy (≤ 15 +6 weeks of gestation) in nulliparous pregnant women selected as "high-risk" by the presence of a bilateral uterine artery notch and/or bilateral uterine artery PI ≥ 1.7 during the first trimester ultrasound scan (11-13+6 weeks), to prevent the occurrence of pre-eclampsia or small for gestational age at birth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Experimental | Drug: AspirinAspirin 160 mg per day |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 160 mg per day |
Who may qualify
- Ages
- 18 months and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Nulliparous (no previous pregnancy ≥ 22 SA)
- Singleton pregnancy
- Gestational age ≤ 15 +6 weeks
- Bilateral uterine artery notch (grade ≥ 2) and/or bilateral uterine artery PI ≥ 1.7 during first trimester ultrasound (CRL between 45 and 84 mm)
Key exclusion criteria (8 listed)
- Women considering voluntary pregnancy termination (≤ 14 weeks)
- Pre-existing (maternal) indication for premature delivery before 37 weeks
- Fetal condition detected during the first trimester scan (fetal malformation or nuchal translucency ≥ 95th percentile)
- Women under anticoagulation
- Allergy or hypersensitivity to Kardegic® or one of its constituents
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 |
|---|---|---|
| AspirinAspirin, 160 mg per day until 34 weeks of gestation | Drug | Aspirin |
| PlaceboPlacebo, 160 mg per day until 34 weeks of gestation | Drug | Placebo |
Primary outcome
Preeclampsia (diagnosed per ACOG criteria) and small for gestational age at birth (≤5th percentile on customized growth curves)
Time frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
6 secondary outcomes
Small for gestational age at birth (≤5th percentile on customized growth curves)
Time frame: women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks
Pre-eclampsia (ACOG criteria) requiring delivery before 34 weeks
Time frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Severe pre-eclampsia (ACOG criteria)
Time frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Perinatal death (22 weeks of gestation to 7 days postnatal)
Time frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Pre-eclampsia (ACOG criteria)
Time frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Adverse effects of treatment
Time frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Background: PubMed 22986844Poon LC, Syngelaki A, Akolekar R, Lai J, Nicolaides KH. Combined screening for preeclampsia and small for gestational age at 11-13 weeks. Fetal Diagn Ther. 2013;33(1):16-27. doi: 10.1159/000341712. Epub 2012 Sep 13.
- Background: PubMed 23004922Ayala DE, Ucieda R, Hermida RC. Chronotherapy with low-dose aspirin for prevention of complications in pregnancy. Chronobiol Int. 2013 Mar;30(1-2):260-79. doi: 10.3109/07420528.2012.717455. Epub 2012 Sep 24.
- Background: PubMed 18634131Plasencia W, Maiz N, Poon L, Yu C, Nicolaides KH. Uterine artery Doppler at 11 + 0 to 13 + 6 weeks and 21 + 0 to 24 + 6 weeks in the prediction of pre-eclampsia. Ultrasound Obstet Gynecol. 2008 Aug;32(2):138-46. doi: 10.1002/uog.5402.
- Results publication: PubMed 36260615Diguisto C, Le Gouge A, Marchand MS, Megier P, Ville Y, Haddad G, Winer N, Arthuis C, Doret M, Debarge VH, Flandrin A, Delmas HL, Gallot D, Mares P, Vayssiere C, Sentilhes L, Cheve MT, Paumier A, Durin L, Schaub B, Equy V, Giraudeau B, Perrotin F; Groupe de Recherche en Obstetrique et Gynecologie (GROG). Low-dose aspirin to prevent preeclampsia and growth restriction in nulliparous women identified by uterine artery Doppler as at high risk of preeclampsia: A double blinded randomized placebo-controlled trial. PLoS One. 2022 Oct 19;17(10):e0275129. doi: 10.1371/journal.pone.0275129. eCollection 2022.
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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. This study is not recruiting at the moment.
Franck PERROTIN, MD-PhD principal investigator
University Hospital, Tours
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin in people with Pre-eclampsia and Intra-uterine Growth Restriction, run by University Hospital, Tours at 17 sites in 2 countries.
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 7 inclusion and 8 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: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France, Martinique. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preeclampsia (diagnosed per ACOG criteria) and small for gestational age at birth (≤5th percentile on customized growth curves) (time frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01729468, which also lists 4 linked publications.
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 22 Dec 2025.