A Phase 3 interventional study of Aspirin 150 mg and Placebo in Chronic Hypertension Complicating Pregnancy, Pre-Eclampsia and Intrauterine Growth Restriction, sponsored by Centre Hospitalier Intercommunal Creteil. Recruiting at 20 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Centre Hospitalier Intercommunal Creteil · Phase 3, Interventional, and Treatment
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Among 52 studies testing aspirin in Pre-Eclampsia — 18 open to participants now, 22 under way, 5 of them phase 3. Aspirin · Pre-Eclampsia.
Among the 52 studies testing aspirin in Pre-Eclampsia, this one is the 14th largest by planned enrollment, is one of 6 that started in 2021, is one of 12 in phase 3, reaches primary completion later than 18 of the 21 other live ones, and was the 21st registered.
917 studies on the registry are indexed under Pre-Eclampsia; 244 are open to participants now.
Browse Pre-Eclampsia studies →18 of the 52 studies testing aspirin in Pre-Eclampsia are open now, in 11 countries. Recruiting first, the newest first:
University of Calgary · Sites in Belgium, Canada, Denmark and 4 more countries
Ages 18+ · Women only
Medicare Hospital (Pvt) Limited · Sites in Pakistan
Ages 18–45 · Women only
NYU Langone Health · Sites in United States
Ages 18–50 · Women only
Thomas Jefferson University · Sites in United States
Ages 16–55 · Women only
Ohio State University · Sites in United States
Ages 14–35 · Women only
By country, each count listing its studies:
Aspirin: first FDA approval 1950 (PERCODAN), first EMA approval 2010. What it is approved for, and how studies give it, is on its page →
Of the 162 Pre-Eclampsia studies recruiting now, 81 (50%) set no upper age limit and 80 (49%) stop at 75 or younger; 18 take children under 18; 60 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
52 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 9 · Phase 3 13 · Phase 4 16
First in 2001; this study’s year is marked. 6 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 500 is above the median of 110 across 481 interventional studies indexed under Pre-Eclampsia.
Median enrollment 235 across the 52 interventional studies. Of the 19 that completed or were terminated, 5 (26%) have results posted.
This tab as a report to print or save as PDF → With an account.
1 of 52 have an industry lead sponsor. The 10 most frequent:
Centre Hospitalier Intercommunal Creteil is the lead sponsor of 131 studies on the registry; 36 are open to participants now.
Centre Hospitalier Intercommunal Creteil has 4 studies filed under Pre-Eclampsia — fewer than ten, so there is no comparison to draw.
6 of the studies testing aspirin in Pre-Eclampsia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05924971MemorialCare Health SystemAspirin for Postpartum Patients With Preeclampsia | 2026-12 |
| NCT04479072University of ChicagoAspirin and Preeclampsia | 2026-12-01 |
| NCT07373756Dr. Sunita PunRandomized Controlled Study to Compare Efficacy of Aspirin 75mg and 150mg In the Prevention of Preeclampsia In High Risk Pregnant Women | 2026-12-31 |
| NCT06281665Malamo CountourisTreatment With Aspirin After Preeclampsia: TAP Trial | 2027-01-01 |
| NCT07041385Shalamar HospitalComparing the Efficacy of 75mg Versus 150mg Aspirin for the Prevention of Preeclampsia in High-Risk Pregnant Women | 2027-06-30 |
Add all 6 to your calendar (.ics) → With an account.
Among the 52 studies testing aspirin in Pre-Eclampsia, from their registry updates:
This tab as a report to print or save as PDF → With an account.
A randomized clinical trial to assess the efficiency of acetylsalicylic acid (aspirin) 150 mg/day started before 20 weeks of gestation in the prevention on maternal and fœtal complications in pregnant women with chronic hypertension.
Chronic hypertension affects 1 to 5% of women of childbearing age. According to the literature, about 45% of pregnant women with chronic hypertension will develop complications such as superimposed preeclampsia (PE), placental abruption, Intra Uterine Growth Restriction (IUGR), perinatal death, maternal death, or preterm delivery. To date, there is no curative treatment of vascular complications of chronic hypertension during pregnancy. The only effective treatment, once the complications are established, is usually stopping the pregnancy and delivering the placenta. The preventive treatment of these complications is therefore an important axis in the improvement of maternal and perinatal health.
Due to the very high risk of superimposed PE in chronic hypertensive patients and despite the lack of objective evidence of the effectiveness of low-dose aspirin in the prevention of superimposed PE in this population, the NICE (National Institute for Health and Care Excellence), associated with the Royal College of Gynecology-Obstetrics, recommends since 2010-2011 the use of low-dose aspirin in the prevention of this complication in chronic hypertensive pregnant women; then it was followed by the "U.S. Preventive Services Task Force (USPTF)" in 2014. Recently, the American College of Obstetrics and Gynecology (ACOG) adopted the suggestions of the USPTF and issued the same recommendations in 2018. The French college of obstetric (CNGOF: National College of French Gynecologists and Obstetricians), however, does not recommend the use of low-dose aspirin in pregnant chronic hypertensive women because of insufficient data.
Indeed, although the efficacy of low-dose aspirin is assumed in patients with previous PE, few studies have evaluated its efficacy in patients with chronic hypertension. Moreover, most of the controlled prospective studies using very low doses of aspirin (less than 100 mg) and starting after 20 weeks of gestation do not seem conclusive. For these reasons, the investigators propose to conduct a prospective randomized double-blind placebo-controlled trial to analyze the effectiveness of aspirin dosed at 150 mg and introduced before 20 weeks of gestation in women with chronic hypertension.
The primary endpoint is a maternal and perinatal composite morbidity and mortality including superimposed PE, intrauterine growth restriction, preterm delivery \< 37 weeks of gestation, placental abruption, perinatal death, or maternal death.
The definition of superimposed PE in our study is the appearance of significant proteinuria in a chronic hypertensive pregnant woman.
In a secondary analyze, the statistician will use the new definition of superimposed PE that does not require the mandatory presence of proteinuria but the association of chronic hypertension and the appearance of neurological signs (eclampsia, persistent headache, visual disturbances, severe nausea or vomiting), pulmonary edema, persistent epigastric pain, thrombocytopenia \<100000 platelets/µL, liver enzymes at 2 times normal, renal insufficiency ( serum creatinine ≥ 97 μmol/L or 1.1 mg/dL,) or a doubling of serum creatinine in the absence of chronic renal disease or significant proteinuria after 20 weeks of gestation or postpartum.
Significant proteinuria is defined as greater than 300 mg/24 hours or when the ratio proteinuria/ creatininuria is ≥ 30 mg/mmol (ratio to 0.3 if all are in mg/dL), in a non-proteinuric women with no urinary tract infection.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Aspirin 150 mg / day (acetylsalicylic acid) once daily in the evening
Drug: Aspirin 150 mg
Placebo taken in the evening
Drug: Placebo
Treatment assigned by randomization will be prescribed immediately and continued throughout pregnancy up to 35 weeks + 6 days for both groups. The active or placebo will be dispensed by the centre's pharmacy. Treatment will be taken in the evening. A daily log is given to patients and must be completed every day.
Also known as: Active arm
Treatment assigned by randomization will be prescribed immediately and continued throughout pregnancy up to 35 weeks + 6 days for both groups. The active or placebo will be dispensed by the centre's pharmacy. Treatment will be taken in the evening. A daily log is given to patients and must be completed every day.
Also known as: comparator arm
Composite morbidity-mortality criterion including preeclampsia, intra-uterine growth retardation <10th percentile, placental abruption, Preterm birth < 37 weeks of gestation, Perinatal death, Maternal death
A composite morbidity-mortality criterion that includes the occurrence during pregnancy or postpartum of at least one of the following events: preeclampsia, IUGR \<10th percentile, placental abruption, Preterm birth \< 37 weeks of gestation, Perinatal death (death from 22 weeks of gestation until 28 days after birth), Maternal death
Time frame: 9 months
IUGR (< 10th percentile of birth weight)
Rate of IUGR (\< 10th percentile of birth weight)
Time frame: 9 months
Placental abruption
Rate of placental abruption
Time frame: 9 months
Preterm birth < 37 weeks of gestation
Rate of severe preterm delivery (\< 37 weeks of gestation)
Time frame: 9 months
Maternal death
Rate of severe maternal death
Time frame: 9 months
Severe pre-eclampsia
Rate of severe pre-eclampsia. Concerning the rate of superimposed PE, it will be analyze according the two definition specified in the rational
Time frame: 9 months
Intrauterine growth restriction (IUGR)
Rate of severe IUGR (\< 5th percentile of birth weight)
Time frame: 9 months
Preterm delivery
Rate of severe preterm delivery (\< 34 weeks of gestation)
Time frame: 8 months
Fetal loss
Rate of fetal loss (fetal loss between 10 and 21 weeks of gestation)
Time frame: 5 months
Fetal death
Rate of fetal death (fetal death from 22 weeks of gestation until delivery)
Time frame: 5 months
Neonatal death
Rate of neonatal death (death from birth until 28 days)
Time frame: 9 months
Neonatal morbidity
Neonatal morbidity (stay in a neonatal intensive care unit, assisted ventilation \> 24 hours, hyaline membrane disease, intraventricular hemorrhages stage III or IV)
Time frame: 9 months
Toxicity of aspirin
Potential toxicity of the treatment: major maternal bleeding event (active externalized, intracranial, intra-ocular, retroperitoneal, articular), or minor,
Time frame: 8 months
Adherence
Adherence of treatment (diary) and its relationship with the efficacy of the preventive effect on primary outcome,
Time frame: 8 months
Biological response to the treatment
Response to the treatment by a urine thromboxane assay
Time frame: 4 months
Angiogenic profile
Circulating and urinary angiogenic profile associated with maternal and fetal clinical data: sFLT1 ( Soluble fms-like tyrosine kinase-1)(serum and urine), PlGF ( Placental Growth Factor)(serum and urine)
Time frame: 9 months
Child development
Child psychomotor development and health problems at 2 years of age
Time frame: 2 years
Child development
Child psychomotor development and health problems at 4 years of age
Time frame: 4 years
Subgroups analysis
Rate of the composite morbidity-mortality criterion in 2 subgroups: treatment started before or after 15 SA
Time frame: 9 months
Not enrolling at this site.
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2021 (actual). Primary completion is estimated for Feb 2029, 96 months after the start.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Aspirin
Centre Hospitalier Intercommunal Creteil →