sFlt1/PlGF and Planned Delivery to Prevent Preeclampsia at Term.
NCT ID: NCT04766866
Last Updated: 2025-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
9132 participants
INTERVENTIONAL
2021-03-02
2026-12-31
Brief Summary
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* 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.
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Detailed Description
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A single-step lab measure to detect PE. Combined algorithms using angiogenic factors with Doppler ultrasound and maternal features seem to achieve the highest performance in detecting pre-clinical PE. However, the need to train staff and change pregnancy care protocols renders difficult generalization in high-resource and even more low-resource settings. On the contrary, single lab tests can be more easily incorporated into the mainstream clinical practice and provide a widespread solution for high-resource settings and specially sub-optimal healthcare systems heavily affected by the consequences of term PE. Angiogenic factors are the obvious candidate for these purposes. The sFlt1/PlGF ratio at 35-36w predicts term PE with a DR of 82% and is a standardized lab test nowadays, realizable by ELISA with widely available automated lab platforms. Normal values in late pregnancy have been reported and are fairly similar among different populations. As preliminary research for this study, the investigators have confirmed that the gestational-age adjusted normal values of sFlt1/PlGF matched quite remarkably those previously published in different populations across Europe. A one-step screening with sFlt1/PlGF would select a 5-10% of the population with the highest risk for PE.
IOL at 37 weeks as an intervention in women at high-risk for PE. Previous trials based on statins have failed to show a reduction of PE in high-risk women. IOL at 37 weeks is an alternative to avoid PE in those high-risk women. IOL has consistently been demonstrated to be safe ( ) and does not affect long-term maternal quality of life ( ). Both the HYPITAT and the DIGITAT randomized trials showed that IOL did not increase caesarean rates or adverse neonatal outcomes ( ). A recent large randomized trial in the US has shown that even in low-risk women, universal IOL decreased cesarean section rates and was well accepted ( ). While in low-risk pregnancies labour induction has been found to be beneficial from 39 weeks (ARRIVE study), in women with placental-related conditions such as hypertension (HYPITAT) or small-for-gestational age (DIGITAT) it is 37+ weeks when the trade-off between neonatal and maternal benefits makes induction recommendable.
Therefore, the investigators hypothesize that a single-step universal screening for term PE based on sFlt1/PlGF ratio at 35-36.6 w followed by IOL at 37w in those women found to be at high risk might represent a feasible and reproducible strategy, applicable worldwide, to reduce the prevalence of term PE without increasing cesarean section rates or adverse neonatal outcomes.
Individual participant data, study protocol, statistical analysis plan and informed consent form will be available with publication by email addresses after approval of a proposal with a signed data access agreement
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
• Intervention group or reveal group (sFlt-1/PlGF result known to clinicians). A ratio cutoff of \>p90th will be used to define low and elevated risk of developing a placental complications of pregnancy and therefore induction of labour will be offered from 37th weeks of gestation Non-intervention or non-reveal (result unknown) group: routine follow-up and spontaneous delivery
Study Groups
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Non-intervention or non-reveal group
Non-intervention or non-reveal (result unknown) group: routine follow-up and spontaneous delivery
No interventions assigned to this group
Intervention group or reveal group
A ratio cutoff of \>p90th will be used to define low and elevated risk of developing a placental complications of pregnancy and therefore induction of labour will be offered from 37th weeks of gestation
sFlt1/PlGF screening in maternal blood at 35 to 36.6 weeks of gestation
A ratio cutoff of \>p90th will be used to define low and elevated risk of developing a placental complications of pregnancy and therefore induction of labour will be offered from 37th weeks of gestation
Interventions
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sFlt1/PlGF screening in maternal blood at 35 to 36.6 weeks of gestation
A ratio cutoff of \>p90th will be used to define low and elevated risk of developing a placental complications of pregnancy and therefore induction of labour will be offered from 37th weeks of gestation
Eligibility Criteria
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Inclusion Criteria
* Singleton pregnancies
* \>18 years old
* 35.0-36.6 weeks of gestation
* Maternal written consent form
Exclusion Criteria
* 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.
18 Years
FEMALE
Yes
Sponsors
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Fundacion Clinic per a la Recerca Biomédica
OTHER
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Responsible Party
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Elisa Llurba
Professor of Obstetric and Gynecology Universitat Autònoma de Barcelona
Locations
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CHU Liège
Liège, , Belgium
Clinica del Prado SAS
Bogotá, , Colombia
Institute for the Care of Mother and Child
Prague, , Czechia
Medicina Fetal Quito
Quito, , Ecuador
Maulana Azad Medical College (MAMC)
New Delhi, National Capital Territory of Delhi, India
All India Institute of Medical Sciences (AIIMS) Ansari Nagar
New Delhi, National Capital Territory of Delhi, India
Vardhman Mahavir Medical College (VMMC)
New Delhi, National Capital Territory of Delhi, India
Hospital Gineco-Obstetricia nº4
Mexico City, , Mexico
Hospital Santo Tomas
Panama City, , Panama
Centre of Postgraduate Medical Education, Obstetrics and Gynecology and Perinatal Medicine
Warsaw, , Poland
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Complejo Hospitalario Universitario Insular Materno Infantil
Las Palmas de Gran Canaria, Canary Islands, Spain
Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Maternitat del Clínic
Barcelona, , Spain
Hospital Sant Joan de Déu
Barcelona, , Spain
Hospital La Paz
Madrid, , Spain
Hospital Son Llatzer
Palma de Mallorca, , Spain
Hospital la Fe
Valencia, , Spain
Hospital Lozano Blesa
Zaragoza, , Spain
Countries
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Central Contacts
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Facility Contacts
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Catalina Valencia, MD, PhD
Role: primary
Belén Nieto, MD, PhD
Role: primary
Sumitra Bachani, MD
Role: primary
Role: backup
Oscar Moreno, MD, PhD
Role: primary
Ameth Hawkins
Role: primary
References
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Llurba E, Crispi F, Crovetto F, Youssef L, Delgado JL, Puig I, Mora J, Krofta L, Mackova K, Martinez-Varea A, Tubau A, Ruiz A, Paya A, Prat M, Chantraine F, Comas C, Kajdy A, Lopez-Tinajero MF, Figueras F, Gratacos E; PE37 study group. Multicentre randomised trial of screening with sFlt1/PlGF and planned delivery to prevent pre-eclampsia at term: protocol of the PE37 study. BMJ Open. 2024 Mar 8;14(3):e076201. doi: 10.1136/bmjopen-2023-076201.
Other Identifiers
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PE37
Identifier Type: -
Identifier Source: org_study_id
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