sFlt1/PlGF and Planned Delivery to Prevent Preeclampsia at Term.
A legfontosabb adatok
- Hol
- Liège (Belgium)A helyszín megnézése
AI-kivonat: kiket keres a vizsgálat
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
A vizsgálat olyan 18 év feletti, először terhes nőket keres, akik egy babát várnak a 35.0-36.6. héten. Vérvizsgálatos szűrést tesztelnek a preeclampsiára, majd a szülés megindítását a 37. héttől.
- Életkor
- 18 évnél idősebb (legalább 18 év).
- Nem
- Csak nők.
- A betegség stádiuma
- Először terhes, egy babát vár, a terhesség 35.0-36.6. hetében jár.
- Biomarker vagy leletérték
- Az anya vérében az sFlt1/PlGF arányt mérik a 35-36.6. héten. A 90. percentilis feletti arányt magas kockázatnak tekintik.
A részvétel fő kizáró okai
- A babának súlyos fejlődési rendellenessége vagy genetikai eltérése van, ami a szülés időpontját vagy a szülés kimenetelét befolyásolhatja
- A baba gyanúsan lassan fejlődik, köztük kóros Doppler-vizsgálati eredménnyel
- Részvétel egy másik vizsgálatban, ami a szülés időpontját megváltoztathatja
- Korábbi szülés
Ez a vizsgálat csak várandós résztvevőket keres. A regiszter mondata, amelyen ez alapul: 35.0-36.6 weeks of gestation
Gépi kiolvasás: 2026. november 12.
Helyszínek itt: Belgium
- CHU LiègeLiège, BelgiumContact: Elisa Llurba, MD; PhDNo longer taking part
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Azonosító
- NCT04766866
- A regiszteradat frissítve
- 2025. február 19.
- Eredeti leírás
* Preeclampsia (PE) affects ~5% of pregnancies. Although improved obstetrical care has significantly diminished associated maternal mortality, PE remains a leading cause of maternal morbidity and mortality in the world. * Term PE accounts for 70% of all PE and a large proportion of maternal-fetal morbidity related with this condition. Prediction and prevention of term PE remains unsolved. * Previously proposed approaches are based on combined screening and/or prophylactic drugs, but these policies are unlikely to be implementable in many world settings. * Recent evidence shows that sFlt1-PlGF ratio at 35-37w predicts term PE with 80% detection rate. * Likewise, recent studies demonstrate that induction of labor (IOL) from 37w is safe. * The investigators hypothesize that a single-step universal screening for term PE based on sFlt1/PlGF ratio at 35-37w followed by IOL from 37w would reduce the prevalence of term PE without increasing cesarean section rates or adverse neonatal outcomes. * The investigators propose a randomized clinical trial to evaluate the impact of a screening of term PE with sFlt-1/PlGF ratio in asymptomatic nulliparous women at 35-37w. Women will be assigned to revealed (sFlt-1/PlGF known to clinicians) versus concealed (unknown) arms. A cutoff of >90th centile will be used to define high risk of PE and offer IOL from 37w. * If successful, the results of this trial will provide evidence to support a simple universal screening strategy reducing the prevalence of term PE, which could be applicable in most healthcare settings and have enormous implications on perinatal outcomes and public health policies worldwide.A teljes eredeti leírásKevesebb
Protocol of the PE37 Study: A Multicenter Randomized Trial of Screening With sFlt1/PlGF and Planned Delivery to Prevent Preeclampsia at Term
* Preeclampsia (PE) affects ~5% of pregnancies. Although improved obstetrical care has significantly diminished associated maternal mortality, PE remains a leading cause of maternal morbidity and mortality in the world. * Term PE accounts for 70% of all PE and a large proportion of maternal-fetal morbidity related with this condition. Prediction and prevention of term PE remains unsolved. * Previously proposed approaches are based on combined screening and/or prophylactic drugs, but these policies are unlikely to be implementable in many world settings. * Recent evidence shows that sFlt1-PlGF ratio at 35-37w predicts term PE with 80% detection rate. * Likewise, recent studies demonstrate that induction of labor (IOL) from 37w is safe. * The investigators hypothesize that a single-step universal screening for term PE based on sFlt1/PlGF ratio at 35-37w followed by IOL from 37w would reduce the prevalence of term PE without increasing cesarean section rates or adverse neonatal outcomes. * The investigators propose a randomized clinical trial to evaluate the impact of a screening of term PE with sFlt-1/PlGF ratio in asymptomatic nulliparous women at 35-37w. Women will be assigned to revealed (sFlt-1/PlGF known to clinicians) versus concealed (unknown) arms. A cutoff of >90th centile will be used to define high risk of PE and offer IOL from 37w. * If successful, the results of this trial will provide evidence to support a simple universal screening strategy reducing the prevalence of term PE, which could be applicable in most healthcare settings and have enormous implications on perinatal outcomes and public health policies worldwide.
Bevonási feltételek: Nulliparous women; Singleton pregnancies; >18 years old; 35.0-36.6 weeks of gestation; Maternal written consent form.
Kizáró feltételek: Fetuses/neonates with major malformations or genetic anomalies that could modify the timing of delivery or has an impact on obstetric outcome; Suspected fetal growth restriction (estimated fetal weight <3 centile or between the 3rd and 10th centile together with abnormal Doppler in the mean uterine artery Doppler pulsatility index, or in umbilical artery pulsatility index or in the middle cerebral artery or in the cerebral umbilical index (CPR)); Participation in another interventional study that could modify the timing of delivery.