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New treatment option for Preeclampsia (PE)
Official title Impact of First-trimester Preeclampsia Screening on Perinatal and Maternal Morbidity (RANSPRE)
ClinicalTrials.gov ID: NCT05521776
What this study is testing
- What it's testing
- The purpose of this study is to determine whether first-trimester screening for preeclampsia based on the FMF algorithm (a combination of maternal clinical, sonographic and biochemical parameters), improves maternal or perinatal health.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Pregnancy between 11 and 14 WG
- Age ≥18 years
- Affiliated to or beneficiary of a health insurance system (including AME)
- Signed informed consent
You likely can't join if
- Gestational age \ 14 WG
- Known ectopic pregnancy
- Known non-ongoing pregnancy
- Known multiple pregnancy
- History of PE in a previous pregnancy
- Pregnancies complicated by major fetal abnormality identified at the first-trimester ultrasound if performed before randomization
See the full eligibility criteria
- Pregnancy between 11 and 14 WG
- Age ≥18 years
- Affiliated to or beneficiary of a health insurance system (including AME)
- Signed informed consent
- Gestational age \ 14 WG
- Known ectopic pregnancy
- Known non-ongoing pregnancy
- Known multiple pregnancy
- History of PE in a previous pregnancy
- Pregnancies complicated by major fetal abnormality identified at the first-trimester ultrasound if performed before randomization
- Absence of health insurance
- Contra-indication to aspirin (bleeding disorders such as von Willebrand's disease, active peptic ulceration, hypersensitivity to aspirin, active peptic ulceration, NSAID-exacerbated respiratory disease, severe liver or...
- Women taking low-dose aspirin regularly and started before pregnancy (except ART indication)
- Age \<18 years
- Poor understanding of the French language
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Bordeaux, France
- Bron, France
- Clamart, France
- Clermont-Ferrand, France
- Créteil, France
- Dijon, France
- Lille, France
- Marseille, France
- Nancy, France
- Nantes, France
- Paris, France
- Poissy, France
- Rennes, France
- Rouen, France
- Strasbourg, France
- Toulouse, France
- Tours, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Bordeaux, France; Bron, France; Clamart, France; Clermont-Ferrand, France; Créteil, France and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.