A phase III, multicentric, Randomized, open-label, parallel-group clinical trial to detect false positives from first-trimester preeclampsia screening (StopPRE) at the second-trimester of pregnancy.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000811-26-ES

Enrollment

1080

Registered

2018-07-09

Start date

2018-09-19

Completion date

Unknown

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First-trimester pre-eclampsia patients MedDRA version: 20.0 Level: PT Classification code 10036485 Term: Pre-eclampsia System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions

Interventions

Trade Name: TROMALYT Product Name: Tromalyt Product Code: 59.210 Pharmaceutical Form: Oral drops INN or Proposed INN: ACETYLSALICYLIC ACID CAS Number: 50-78-2 Other descriptive name: ACETYLSALICYLIC A

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients older than 18 years old - Gestational period less than 28+0 weeks - Unique gestation - High-risk of pre-eclampsia for the first-trimester screening, defined through a validated multivariate algorithm for the population under study - AAS initiation taken = 16 + 6 weeks of pregnancy - Ratio sFlt1 / PlGF determined between the weeks of pregnancy 24-27 + 6 - Voluntary signature of the informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1134 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Multiple gestation - Dead and/or multiple malformation fetus, including also any genetical and/or cromosomical disseas affected by the fetus. - Von Willebrand dissease. - ASA intolerance and /or allergy - Peptic ulcer - Patients with misunderstanding or not able to understand the protocol, including also any condition which could compromise the compliance of the protocol, according to the investigator's opinion. - AAS compliance <50% up to the current visit - Antiphospholipid syndrome - No signature of the informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: To demostrate no increasement of incidence of preterm pre-emclampsia, comparing with a control-group patients who are taking the treatment as usual, when sFlt-1/PlGF ratio is less than 38 and patients are under 24-27 weeks of pregnancy.;Primary end point(s): - Preterm preeclampsia rate (< 37 weeks) within the two arms of the high-risk group under sFlt1/PlGF ratio less than 38 between 24-27+6 weeks of pregnancy.;Timepoint(s) of evaluation of this end point: - At the end of the study period (24-27+6 - 37 weeks of pregnancy);Secondary Objective: - To demostrate that determination of sFlt-1/PlGF ratio, between 24-27+6 weeks of pregnancy, achieves to detect false positives using first-trimester pre-emclapsia screening. - To demostrate that patients within sFlt-1/PlGF ratio less than 38, between 24-27+6 weeks of prenancy, whether you suspend the treatment with ASA, it is not increase the maternal morbility or mortality. - To demostrate that patients within sFlt-1/PlGF ratio less than 38, between 24-27+6 weeks of prenancy, the suspension of ASA reduces the incidence of minor maternal hemorrhages. -To demostrate that in high-risk pre-eclampsia patients, the detection of sFlt-1/PlGF ratio less than 38 between 24-27+6 weeks of prenancy, assumes a relief for those patients who get stress as the cognisance of high-risk group assignment for patients - To know the outcome of all patients with high-risk pre-eclampsia.	—

Measure

Time frame

Main Objective: To demostrate no increasement of incidence of preterm pre-emclampsia, comparing with a control-group patients who are taking the treatment as usual, when sFlt-1/PlGF ratio is less than 38 and patients are under 24-27 weeks of pregnancy.;Primary end point(s): - Preterm preeclampsia rate (< 37 weeks) within the two arms of the high-risk group under sFlt1/PlGF ratio less than 38 between 24-27+6 weeks of pregnancy.;Timepoint(s) of evaluation of this end point: - At the end of the study period (24-27+6 - 37 weeks of pregnancy);Secondary Objective: - To demostrate that determination of sFlt-1/PlGF ratio, between 24-27+6 weeks of pregnancy, achieves to detect false positives using first-trimester pre-emclapsia screening. - To demostrate that patients within sFlt-1/PlGF ratio less than 38, between 24-27+6 weeks of prenancy, whether you suspend the treatment with ASA, it is not increase the maternal morbility or mortality. - To demostrate that patients within sFlt-1/PlGF ratio less than 38, between 24-27+6 weeks of prenancy, the suspension of ASA reduces the incidence of minor maternal hemorrhages. -To demostrate that in high-risk pre-eclampsia patients, the detection of sFlt-1/PlGF ratio less than 38 between 24-27+6 weeks of prenancy, assumes a relief for those patients who get stress as the cognisance of high-risk group assignment for patients - To know the outcome of all patients with high-risk pre-eclampsia.

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: - Along the study period. - Along the study period. - 24-27+6, 28-31+6 weeks of pregnancy - 24-27+6, 28-31+6, 32-35+6, 36 y 37 weeks of pregnancy - 24-27+6, 28-31+6, 32-35+6, 36 y 37 weeks of pregnancy - 4 months after the birth of the baby;Secondary end point(s): - Prevalence of early, preterm and late pre-eclampsia at high-risk group and ratio = 38 - Rate of adherence to the treatment assignated to high-risk screening group of patients - Stress perception by 'Perceived Stress Scale (PSS) of Cohen, S., Kamarck, T., & Mermelstein, R. This scale is evaluated the last month, having 14 items with an outcome defined by an scale of 5 points. It will be done in both groups of study. Seeing questionaries at anexo section. - Hemorrhagea along gestation at both groups of study (studying symptoms such as epistaxis, gingivorrhagia and genital bleeding) - Rate of maternal issues in both groups (sFlt1/PlGF ratio < 38 and sFlt1/PlGF ratio= 38) such as placental detachment, caesarea detected by abnormal cardiotocography, fetus death, undertaking more than 2 antidepressants, eclampsia, diseminated intravascular coagulation, maternal mortality, postpartum hemorraghea, accurate lung oedema, brain vascular hemorraghea, stroke, sepsis, income to intensive care and second-surgery needed. - Neonatal complications in both groups such as early partum, income at intensive care, Acute respiratory distress, Grade II-IV intravascular hemorraghea, patent ductus arteriosus, renal disfuntion, Necrotizing enterocolitis, intestinal perforation, sepsis, retinopathy of prematurity, Bronchopulmonary dysplasia, Periventricular leukomalacia, intrauterine growth restriction, postnatal administration of sulphactants or inotropics drugs and/or death.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: - Along the study period. - Along the study period. - 24-27+6, 28-31+6 weeks of pregnancy - 24-27+6, 28-31+6, 32-35+6, 36 y 37 weeks of pregnancy - 24-27+6, 28-31+6, 32-35+6, 36 y 37 weeks of pregnancy - 4 months after the birth of the baby;Secondary end point(s): - Prevalence of early, preterm and late pre-eclampsia at high-risk group and ratio = 38 - Rate of adherence to the treatment assignated to high-risk screening group of patients - Stress perception by 'Perceived Stress Scale (PSS) of Cohen, S., Kamarck, T., & Mermelstein, R. This scale is evaluated the last month, having 14 items with an outcome defined by an scale of 5 points. It will be done in both groups of study. Seeing questionaries at anexo section. - Hemorrhagea along gestation at both groups of study (studying symptoms such as epistaxis, gingivorrhagia and genital bleeding) - Rate of maternal issues in both groups (sFlt1/PlGF ratio < 38 and sFlt1/PlGF ratio= 38) such as placental detachment, caesarea detected by abnormal cardiotocography, fetus death, undertaking more than 2 antidepressants, eclampsia, diseminated intravascular coagulation, maternal mortality, postpartum hemorraghea, accurate lung oedema, brain vascular hemorraghea, stroke, sepsis, income to intensive care and second-surgery needed. - Neonatal complications in both groups such as early partum, income at intensive care, Acute respiratory distress, Grade II-IV intravascular hemorraghea, patent ductus arteriosus, renal disfuntion, Necrotizing enterocolitis, intestinal perforation, sepsis, retinopathy of prematurity, Bronchopulmonary dysplasia, Periventricular leukomalacia, intrauterine growth restriction, postnatal administration of sulphactants or inotropics drugs and/or death.

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Countries

Spain

Contacts

Public ContactARO

Vall D'hebron Institut de Recerca (VHIR)

aro@vhir.org349348930004113

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026