Impact of First-trimester Preeclampsia Screening on Perinatal and Maternal Morbidity (RANSPRE)
RANSPRE
2 other identifiers
interventional
14,500
1 country
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2023
Longer than P75 for not_applicable
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2022
CompletedFirst Posted
Study publicly available on registry
August 30, 2022
CompletedStudy Start
First participant enrolled
March 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
March 27, 2026
March 1, 2026
3.4 years
July 7, 2022
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Severe perinatal morbidity
The primary outcome will be severe perinatal morbidity defined by a composite criterion including at least one of the following: * perinatal mortality (stillbirth ≥ 20 WG or with birth weight \> 500 g or neonatal death within 7 days of life) or prematurity \< 34 WG or birth weight \< 3° percentile. * prematurity \< 34 WG: birth before ≥ 34 WG * birth weight \< 3° percentile
From birth up to 7 days of life
Secondary Outcomes (11)
Incidence of preeclampsia
From inclusion up to discharge from hospital after delivery (max 30 days)
Incidence of components of moderate and severe maternal morbidity
From inclusion up to discharge from hospital after delivery (max 30 days)
Incidence of components of moderate and severe perinatal morbidity
During pregnancy and up to discharge from hospital (max 30 days) - Intraventricular hemorrage grade II or above-Anemia requiring blood transfusion-Respiratory distress
Impact of first-trimester PE screening on potential adverse events
From inclusion up to discharge from hospital (max 30 days)
Aspirin side effects
From inclusion up to discharge from hospital (max 30 days)
- +6 more secondary outcomes
Study Arms (2)
With first trimester preeclampsia screening
EXPERIMENTALRisk assessment of developing preeclampsia between 11 and 14 WG based on maternal parameters, blood pressure measurement, Doppler measurements of the uterine arteries and maternal PlGF concentration. Patients at high risk of preeclampsia are treated with aspirin.
Without first trimester preeclampsia screening
NO INTERVENTIONUsual prenatal care
Interventions
An algorithm assessing the risk of developing preeclampsia combining maternal parameters, blood pressure measurement, Doppler measurements of the uterine arteries and maternal PlGF concentrations. For women in the screening group, a Doppler study of the uterine arteries and a blood test to quantify PlGF concentrations will be performed within 2 days of randomization, allowing the risk to be calculated according to the screening test. For women with a positive screening test (i.e. predicted risk\> 1/100), a treatment with aspirin will be prescribed at 160 mg/day, started as soon as possible and before 15 WG, and taken up to 36 WG, in the absence of contraindications. For women with negative screening, usual pregnancy monitoring without aspirin will be offered.
Eligibility Criteria
You may qualify 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 may not qualify if:
- Gestational age \<11 WG or \>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 heart dysfunction)
- Women taking low-dose aspirin regularly and started before pregnancy (except ART indication)
- Age \<18 years
- Poor understanding of the French language
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- URC-CIC Paris Descartes Necker Cochincollaborator
- INSERM, Epopé teamcollaborator
- Assistance Publique - Hôpitaux de Parislead
Study Sites (22)
CHU Angers
Angers, France
CHU de Bordeaux
Bordeaux, France
Hôpital Femme Mère Enfant
Bron, France
Hôpital Antoine Béclère
Clamart, France
CHU Estaing
Clermont-Ferrand, France
Hôpital Intercommunal Créteil
Créteil, France
CHU Dijon Bourgogne
Dijon, France
CHU Lille
Lille, France
Hôpital de la conception et de la Timone
Marseille, France
Hôpital Nord
Marseille, France
CHRU de Nancy
Nancy, France
Hôpital Femme - Maternité
Nantes, France
Hôpital Armand Trousseau
Paris, France
Hôpital Cochin (site Port-Royal)
Paris, France
Hôpital Saint-Joseph
Paris, France
CHI de Poissy
Poissy, France
Hôpital Sud Rennes
Rennes, France
CHU Charles Nicolle
Rouen, France
CHU Strasbourg, CMCO Schiltigheim
Strasbourg, France
Hôpital de Hautepierre
Strasbourg, France
Hôpital Paule de Viguier
Toulouse, France
Hôpital Bretonneau
Tours, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Catherine DENEUX, MD, PhD
Institut National de la Santé Et de la Recherche Médicale, France
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2022
First Posted
August 30, 2022
Study Start
March 6, 2023
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
February 1, 2027
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share