RecruitingPhase 3NCT04356326

Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy

Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy, a Multicenter Prospective Randomized Double-blind Placebo-controlled Trial.


Sponsor

Centre Hospitalier Intercommunal Creteil

Enrollment

500 participants

Start Date

Feb 15, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether low-dose aspirin, taken during pregnancy, can reduce complications for women with chronic high blood pressure who are pregnant. High blood pressure in pregnancy increases the risk of preeclampsia (a dangerous condition) and other problems for both mother and baby. **You may be eligible if:** - You are pregnant, between 10 and 19 weeks and 6 days of pregnancy - You have chronic high blood pressure (either already being treated or newly diagnosed before randomization) - You are carrying a single baby (not twins or more) - You have signed informed consent **You may NOT be eligible if:** - You need blood thinners for another medical reason (e.g., blood clots, antiphospholipid syndrome, mechanical heart valves) - You are already taking aspirin for another condition - You have significant protein in your urine (a sign of kidney damage) - You have active bleeding or aspirin allergy - You are carrying multiple babies Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAspirin 150 mg

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.

DRUGPlacebo

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.


Locations(20)

CHU Bordeaux

Bordeaux, France

CHU Caen

Caen, France

CHU Antoine Béclère, AP-HP

Clamart, France

Hôpital Louis Mourier, AP-HP

Colombes, France

Centre Hospitalier Intercommunal de Créteil

Créteil, France

CHU Dijon

Dijon, France

CHU Bicêtre, AP-HP

Le Kremlin-Bicêtre, France

CHRU Lille

Lille, France

CHU Lyon

Lyon, France

Hôpital St Joseph

Marseille, France

CHRU Nancy

Nancy, France

CHU Nantes

Nantes, France

CHU Cochin- Port Royal, AP-HP

Paris, France

CHU Robert Débré, AP-HP

Paris, France

CHU Tenon

Paris, France

Hôpital Trousseau, AP-HP

Paris, France

CH Poissy

Poissy, France

CHU St Etienne

Saint-Etienne, France

CHU Toulouse

Toulouse, France

CHU Tours

Tours, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04356326


Related Trials