Actively Recruiting
Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy, a Multicenter Prospective Randomized Double-blind Placebo-controlled Trial
Led by Centre Hospitalier Intercommunal Creteil · Updated on 2025-09-02
500
Participants Needed
20
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether taking 150 mg of aspirin daily before 20 weeks of pregnancy can help prevent complications in pregnant women with chronic hypertension. Chronic hypertension during pregnancy can lead to serious issues like preeclampsia, placental abruption, growth problems for the baby, early birth, and death of the mother or baby. Current guidelines recommend low-dose aspirin for some pregnant women at risk, but there is limited evidence specifically for those with chronic hypertension, so this study seeks to clarify its effectiveness. Participants will be randomly assigned to take either 150 mg of aspirin or a placebo once daily in the evening, starting before 20 weeks of pregnancy and continuing until about 36 weeks gestation. The study is double-blind, meaning neither the participants nor the researchers know who receives aspirin or placebo. Both groups will follow the same schedule, and treatment adherence is tracked with a daily log. During the study, participants will be monitored for maternal and baby health outcomes including preeclampsia, fetal growth, preterm birth, placental abruption, and any deaths. The trial also measures aspirin's biological effects, side effects, and child development up to four years after birth. Study visits and assessments will occur throughout pregnancy and after delivery, with safety and treatment response carefully evaluated over time.
CONDITIONS
Brief Title
Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant woman between 10 and 19 weeks plus 6 days of gestation
- Diagnosed with chronic hypertension before or during pregnancy
- Singleton pregnancy
- Signed written informed consent
- Affiliated to social security
You will not qualify if you...
- Medical history requiring anticoagulation (e.g., antiphospholipid syndrome, deep vein thrombosis, pulmonary embolism, atherothrombosis, mechanical heart valves)
- Currently taking aspirin for another reason outside pregnancy
- Significant proteinuria over 300 mg/24 hours or proteinuria/creatininuria ratio ≥ 30 mg/mmol
- Active bleeding
- History of severe preeclampsia with delivery before 34 weeks
- Allergy to aspirin or similar drugs
- Platelet count below 100,000 cells/microliter (test within 6 months)
- Blood clotting disorders including hemophilia
- Any bleeding diseases including digestive bleeding, hemorrhagic stroke, thrombocytopenia
- Positive for HIV or hepatitis B or C viruses
- Participating in another interventional study that could interfere
- Under 18 years old
- Under legal protection
- Psychiatric follow-up, poor French understanding, or cognitive problems
- Duodenal ulcer
- Severe kidney, liver, or heart impairment
- Gout
- Known glucose-6-phosphate dehydrogenase deficiency
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - From enrollment until 35 weeks + 6 days of pregnancy
Participants take either aspirin 150 mg or placebo once daily in the evening, starting immediately after enrollment and continuing throughout pregnancy up to 35 weeks and 6 days.
Regular visits for treatment dispensation and monitoring (visit frequency as per local center protocol)
Duration - Up to 9 months including delivery and immediate postpartum period
Participants are monitored for maternal and perinatal health outcomes including preeclampsia, intrauterine growth restriction, preterm birth, placental abruption, and mortality up to delivery and beyond.
Visits aligned with pregnancy follow-up and delivery; visit frequency may vary
Trial Site Locations
Total: 20 locations
1
CHU Bordeaux
Bordeaux, France
Actively Recruiting
2
CHU Caen
Caen, France, 14000
Withdrawn
3
CHU Antoine Béclère, AP-HP
Clamart, France
Actively Recruiting
4
Hôpital Louis Mourier, AP-HP
Colombes, France
Actively Recruiting
5
Centre Hospitalier Intercommunal de Créteil
Créteil, France, 94000
Actively Recruiting
6
CHU Dijon
Dijon, France
Actively Recruiting
7
CHU Bicêtre, AP-HP
Le Kremlin-Bicêtre, France
Actively Recruiting
8
CHRU Lille
Lille, France
Not Yet Recruiting
9
CHU Lyon
Lyon, France
Actively Recruiting
10
Hôpital St Joseph
Marseille, France
Withdrawn
11
CHRU Nancy
Nancy, France
Withdrawn
12
CHU Nantes
Nantes, France
Actively Recruiting
13
CHU Cochin- Port Royal, AP-HP
Paris, France
Actively Recruiting
14
CHU Robert Débré, AP-HP
Paris, France
Actively Recruiting
15
CHU Tenon
Paris, France
Actively Recruiting
16
Hôpital Trousseau, AP-HP
Paris, France
Actively Recruiting
17
CH Poissy
Poissy, France
Actively Recruiting
18
CHU St Etienne
Saint-Etienne, France
Actively Recruiting
19
CHU Toulouse
Toulouse, France
Not Yet Recruiting
20
CHU Tours
Tours, France
Withdrawn
Research Team
E
Edouard LE CARPENTIER
C
Camille JUNG
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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