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Angiogenic Markers for Confirming Term Preeclampsia (noPE-37 Trial): An Open-Label, Randomized Controlled Trial

Status: Recruiting
Location: See all (23) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study tests the hypothesis that, in women with preeclampsia without severe features, delivery management based on sFlt-1/PlGF would reduce the rate of induction of labor without worsening the rate of progression to preeclampsia with severe features and other maternal complications.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years

• Singleton pregnancy

• Preeclampsia without severe features according to the ACOG definition

• Antegrade diastolic flow in the umbilical artery Doppler

• Gestational age between 36+0 and 38+6 weeks of gestation

• Gestational age confirmed by fetal crown-rump length measurement in the first-trimester scan (from 11+0 to 13+6 weeks of gestation) or by in vitro fertilization dates

Locations
Other Locations
Spain
Hospital Universitario de A Coruña
RECRUITING
A Coruña
Hospital General Universitari Dr. Balmis
RECRUITING
Alicante
Hospital Universitari Dexeus
RECRUITING
Barcelona
Vall d'Hebron Hospital Campus
RECRUITING
Barcelona
Hospital Universitario de Cabueñes
RECRUITING
Cabueñes
Hospital Universitario Puerta del Mar
RECRUITING
Cadiz
Hospital General Universitario de Elche
RECRUITING
Elche
Hospital Universitario de Getafe
RECRUITING
Getafe
Hospital Universitari de Girona Doctor Josep Trueta
RECRUITING
Girona
Hospital Universitario San Cecilio
RECRUITING
Granada
Hospital Universitario de Jerez
RECRUITING
Jerez De La Frontera
Hospital Materno Infantil de Gran Canaria
RECRUITING
Las Palmas De Gran Canaria
Hospital Universitari Arnau de Vilanova
RECRUITING
Lleida
Hospital universitario 12 de Octubre
RECRUITING
Madrid
Hospital Clínico Universitario Virgen de la Arrixaca
RECRUITING
Murcia
Hospital Universitari Son Espases
RECRUITING
Palma De Mallorca
Hospital Universitario Virgen de Valme
RECRUITING
Seville
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Hospital Universitari de Tarragona Joan XXIII
RECRUITING
Tarragona
Consorci Sanitari de Terrassa
RECRUITING
Terrassa
Hospital Universitari MútuaTerrassa
RECRUITING
Terrassa
Hospital Universitario de Torrejón
RECRUITING
Torrejón
Hospital Universitario Lozano Blesa
RECRUITING
Zaragoza
Contact Information
Primary
Erika Bonacina, MD, PhD
erika.bonacina@vallhebron.cat
003493 489 30 00
Time Frame
Start Date: 2025-12-04
Estimated Completion Date: 2028-04
Participants
Target number of participants: 750
Treatments
Active_comparator: Standard care: elective delivery at 37 weeks of gestation
In the control group, a blood test to assess the sFlt-1/PlGF ratio will be performed, and the result will be concealed from investigators. As in current clinical practice, elective delivery will be scheduled at 37 weeks. If preeclampsia is first diagnosed after 37 weeks, immediate delivery will be recommended. If at any time after enrollment any of the following is present, immediate delivery (within 24 hours) will be recommended: preeclampsia with severe features according to ACOG criteria, decreased fetal movements, absent or reversed diastolic flow in the umbilical artery, non-reassuring CTG, biophysical profile score ≤6, or oligohydramnios.
Experimental: Intervention arm: expectant management if sFlt-1/PlGF<38
If sFlt-1/PlGF \<38, expectant management will be followed until 39 weeks. If any other medical condition is present, local protocols for the specific condition will be followed. If fetal growth restriction in present (with antegrade diastolic umbilical flow), weekly repetition of sFlt-1/PlGF wil be done. If sFlt-1/PlGF ≥38, delivery at 37 weeks will be recommended, or immediate delivery if the patient is enrolled after 37 weeks. If at any time after enrollment any of the following is present, immediate delivery (within 24 hours) will be recommended: preeclampsia with severe features according to ACOG criteria, decreased fetal movements, absent or reversed diastolic flow in the umbilical artery, non-reassuring CTG, biophysical profile score ≤6, sFlt-1/PlGF ≥38 or oligohydramnios.
Related Therapeutic Areas
Sponsors
Leads: Hospital Universitari Vall d'Hebron Research Institute
Collaborators: Instituto de Salud Carlos III

This content was sourced from clinicaltrials.gov