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Phase 3
Age: 18Years +
FEMALE
ID04356326

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 aspirins 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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

Research Team

E

Edouard LE CARPENTIER

C

Camille JUNG

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