PreeclampsiaNOPE37NCT07193680
NOPE37: Angiogenic Factors for Managing Term Preeclampsia
A study testing Intervention arm: expectant management if sFlt-1/PlGF<38 in people with Preeclampsia, run by Hospital Universitari Vall d'Hebron Research Institute at 23 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Intervention arm: expectant management if sFlt-1/PlGF<38
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 23 sitesSpain
- Study dates
- 4 Dec 2025to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Fetal death
- Preeclampsia with severe features according to the ACOG definition, eclampsia, or any condition that requires immediate delivery
- Absent or reversed end-diastolic flow in the umbilical artery Doppler
- Non-reassuring CTG
- Decreased fetal movements
- Biophysical profile score ≤6
Show all 11Show fewer
- Oligohydramnios
- Refusal to provide informed consent
- Fetal malformation
- Placental abruption
- Antiphospholipid antibody syndrome
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
Spain23 sites, 23 recruiting
- Recruiting
Hospital Universitario de A Coruña
A Coruña
Esther Canedo, +34981 178 000, esther_canedo@yahoo.es
- Recruiting
Hospital General Universitari Dr. Balmis
Alicante
Ana Palacios, +34965 933 000, ana.palacios.marques@gmail.com
- Recruiting
Hospital Universitari Dexeus
Barcelona, BARCELONA, 08024
Raquel Mula, +3493 227 47 47, raqmul@dexeus.com
- Recruiting
Vall d'Hebron Hospital Campus
Barcelona
Hospital Vall d'Hebron, +34 93 489 30 00, erika.bonacina@vallhebron.cat
- Recruiting
Hospital Universitario de Cabueñes
Cabueñes
Esther Perez, +34985 185 000, estherpcarbajo@hotmail.com
- Recruiting
Hospital Universitario Puerta del Mar
Cadiz
Victoria Melero, +34956 00 21 00, melerojimenez@hotmail.com
- Recruiting
Hospital General Universitario de Elche
Elche
Claudia Rodriguez, +34966 616 900, clau.rodmon@gmail.com
- Recruiting
Hospital Universitario de Getafe
Getafe
Elena Pintado, +3491 683 93 60, elenapintadoparedes@gmail.com
- Recruiting
Hospital Universitari de Girona Doctor Josep Trueta
Girona
Anna Maroto, +34972 94 02 00, annamaroto@gmail.com
- Recruiting
Hospital Universitario San Cecilio
Granada
Maria Carmen Jimenez, +34958 023 000, mcarmenjimenezhernandez@gmail.com
- Recruiting
Hospital Universitario de Jerez
Jerez de la Frontera
Cristina Romero, +34956 03 20 00, CRGARRI@GMAIL.COM
- Recruiting
Hospital Materno Infantil de Gran Canaria
Las Palmas de Gran Canaria
Leonor Valle, +34928 444 500, leonorvalle@yahoo.es
- Recruiting
Hospital Universitari Arnau de Vilanova
Lleida
Sandra Borderia, +34973 248 100, sb.rabassa@gmail.com
- Recruiting
Hospital universitario 12 de Octubre
Madrid
Ignacio Herraiz, +3491 390 80 00, ignacio.herraiz@salud.madrid.org
- Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia
Marisa Sanchez, +34968 36 95 00, marisa00111@hotmail.com
- Recruiting
Hospital Universitari Son Espases
Palma de Mallorca
Maria Vila, +34871 20 50 0, mariavilacortes@gmail.com
- Recruiting
Hospital Universitario Virgen de Valme
Seville
Carlota Borrero, +34955 01 50 00, carlotaborrero@gmail.com
- Recruiting
Hospital Universitario Virgen Macarena
Seville
Isabel Fontan, +34955 00 80 00, imfontanatal@gmail.com
- Recruiting
Hospital Universitari de Tarragona Joan XXIII
Tarragona
Monica Lopez, monicalopez4099@gmail.com ext. +34977 29 58 0, monicalopez4099@gmail.com
- Recruiting
Consorci Sanitari de Terrassa
Terrassa
Esperanza Garcia, +3493 731 00 07, egcancela@me.com
- Recruiting
Hospital Universitari MútuaTerrassa
Terrassa
Eva Lopez, +3493 736 50 50, evalq@hotmail.com
- Recruiting
Hospital Universitario de Torrejón
Torrejón
Raquel Martin, +3491 626 26 00, raqmaral@gmail.com
- Recruiting
Hospital Universitario Lozano Blesa
Zaragoza
Daniel Oros, +34976 76 57 00, danoros@gmail.com
About this study
Official title: Angiogenic Markers for Confirming Term Preeclampsia (noPE-37 Trial): An Open-Label, Randomized Controlled Trial
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.
Read the detailed description
Participants with preeclampsia without severe features between 36 and 38+6 weeks, who do not meet any exclusion criteria, will be randomly assigned to two groups:
- In the study group, if angiogenic factors are normal (sFlt-1/PlGF <38), delivery will be delayed until 39 weeks; if any other medical condition is present, delivery will be scheduled according to the specific protocol for it.
- In the study group, if angiogenic factors are abnormal (sFlt-1/PlGF ≥38), labor will be induced at ≥37 weeks.
- In the control group, labor will be recommended at 37 weeks, as is currently standard.
- In both groups, NT-proBNP levels will be measured at enrollment.
- In both groups, a satisfaction questionnaire will be completed at enrollment and 4 weeks after delivery.
- In both groups, if any of the following is present, delivery will be recommended immediately (within 24 hours):
- 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
- oligohydramnios (largest vertical pocket <2 cm)
- Conditions
- Preeclampsia
- Being tested
- Intervention arm: expectant management if sFlt-1/PlGF<38, Standard care: elective delivery at 37 weeks of gestation
- Keywords
- preeclampsia, angiogenic factors, expectant management
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention arm: expectant management if sFlt-1/PlGF<38Other
If the angiogenic factors are normal (sFlt-1/PlGF <38), expectant management will be followed until 39 weeks, instead of delivery at ≥37 weeks of gestation as in standard care for preeclampsia without severe features.
Standard care: elective delivery at 37 weeks of gestationOther
In the control arm, standard care for preeclampsia without severe features will be followed: elective delivery at ≥37 weeks of gestation.
| Study group | Role | What they receive |
|---|---|---|
| Standard care: elective delivery at 37 weeks of gestation | Active comparator | 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. Receives: Other: Standard care: elective delivery at 37 weeks of gestation |
| Intervention arm: expectant management if sFlt-1/PlGF<38 | Experimental | 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. Receives: Other: Intervention arm: expectant management if sFlt-1/PlGF<38 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite maternal outcome
The primary outcome is a composite poor maternal outcome, defined as maternal mortality, severe maternal morbidity (eclampsia, HELLP syndrome, thromboembolic disease, pulmonary edema, or placental abruption), preeclampsia with severe features, and major postpartum hemorrhage (>1000 mL).
Measured: through study completion, an average of 2 months
Secondary outcomes (13)
Neonatal morbidity
Neonatal morbidity is defined as the occurrence of at least one of the following: 5-minute Apgar score <7, NICU admission, fetal death, neonatal death, sepsis, hypoglycemia, transient tachypnea of the newborn, respiratory distress syndrome, meconium aspiration syndrome, periventricular leukomalacia, intraventricular hemorrhage, seizures, necrotizing enterocolitis, neonatal jaundice requiring phototherapy, neonatal birthweight <2500 g, or elective early-term delivery (37+0-38+6 weeks of gestation).
Measured: through study completion, an average of 2 months
Method of delivery
Method of delivery, onset of labor, operative vaginal delivery for fetal distress, cesarean section for fetal distress.
Measured: through study completion, an average of 2 months
Maternal admission to ICU
Maternal admission to ICU (yes/no)
Measured: through study completion, an average of 2 months
Days of maternal admission to ICU
Duration of maternal admission to ICU (days)
Measured: through study completion, an average of 2 months
Gestational age at delivery
Gestational age at delivery (weeks and days)
Measured: through study completion, an average of 2 months
Birthweight
Birthweight in grams
Measured: through study completion, an average of 2 months
Birthweight percentile
Birthweight percentile (%) according to local reference charts
Measured: through study completion, an average of 2 months
Prematurity
Prematurity (delivery <37 weeks of gestation), yes/no
Measured: through study completion, an average of 2 months
Days of neonatal admission to NICU
duration of neonatal admission to NICU (days)
Measured: through study completion, an average of 2 months
Metabolic acidosis
Umbilical artery pH <7.10 and base excess <-12 mmol/L (yes/no)
Measured: through study completion, an average of 2 months
Need of maternal corticosteroids
Need of maternal corticosteroids (yes/no)
Measured: through study completion, an average of 2 months
Maternal NT-proBNP levels
Maternal NT-proBNP levels (pg/mL)
Measured: through study completion, an average of 2 months
Maternal satisfaction measured by the Generic Short Patient Experiences Questionnaire (GS-PEQ)
Ten-item measure scored 1-5 per item (total range 10-50; higher scores = better patient experiences).
Measured: through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start4 Dec 2025
- Primary completionDec 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193680
- Sponsor's protocol ID
- PR(AMI)392-2023
- Acronym
- NOPE37
- Status last verified
- Dec 2025
- First submitted
- 21 Jul 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiogenic Markers for Confirming Term Preeclampsia (noPE-37 Trial): An Open-Label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07193680
- Acronym / sponsor ID
- NOPE37 / PR(AMI)392-2023
- Conditions
- Preeclampsia
- Keywords
- preeclampsia, angiogenic factors, expectant management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants with preeclampsia without severe features between 36 and 38+6 weeks, who do not meet any exclusion criteria, will be randomly assigned to two groups:
- In the study group, if angiogenic factors are normal (sFlt-1/PlGF <38), delivery will be delayed until 39 weeks; if any other medical condition is present, delivery will be scheduled according to the specific protocol for it.
- In the study group, if angiogenic factors are abnormal (sFlt-1/PlGF ≥38), labor will be induced at ≥37 weeks.
- In the control group, labor will be recommended at 37 weeks, as is currently standard.
- In both groups, NT-proBNP levels will be measured at enrollment.
- In both groups, a satisfaction questionnaire will be completed at enrollment and 4 weeks after delivery.
- In both groups, if any of the following is present, delivery will be recommended immediately (within 24 hours):
- 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
- oligohydramnios (largest vertical pocket <2 cm)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care: elective delivery at 37 weeks of gestation | Active comparator | Other: Standard care: elective delivery at 37 weeks of gestationIn 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. |
| Intervention arm: expectant management if sFlt-1/PlGF<38 | Experimental | Other: Intervention arm: expectant management if sFlt-1/PlGF<38If 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- Fetal death
- Preeclampsia with severe features according to the ACOG definition, eclampsia, or any condition that requires immediate delivery
- Absent or reversed end-diastolic flow in the umbilical artery Doppler
- Non-reassuring CTG
- Decreased fetal movements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention arm: expectant management if sFlt-1/PlGF<38If the angiogenic factors are normal (sFlt-1/PlGF <38), expectant management will be followed until 39 weeks, instead of delivery at ≥37 weeks of gestation as in standard care for preeclampsia without severe features. | Other | Intervention arm: expectant management if sFlt-1/PlGF<38 |
| Standard care: elective delivery at 37 weeks of gestationIn the control arm, standard care for preeclampsia without severe features will be followed: elective delivery at ≥37 weeks of gestation. | Other | Standard care: elective delivery at 37 weeks of gestation |
Primary outcome
Composite maternal outcome
Time frame: through study completion, an average of 2 months
The primary outcome is a composite poor maternal outcome, defined as maternal mortality, severe maternal morbidity (eclampsia, HELLP syndrome, thromboembolic disease, pulmonary edema, or placental abruption), preeclampsia with severe features, and major postpartum hemorrhage (>1000 mL).
13 secondary outcomes
Neonatal morbidity
Time frame: through study completion, an average of 2 months
Method of delivery
Time frame: through study completion, an average of 2 months
Maternal admission to ICU
Time frame: through study completion, an average of 2 months
Days of maternal admission to ICU
Time frame: through study completion, an average of 2 months
Gestational age at delivery
Time frame: through study completion, an average of 2 months
Birthweight
Time frame: through study completion, an average of 2 months
Birthweight percentile
Time frame: through study completion, an average of 2 months
Prematurity
Time frame: through study completion, an average of 2 months
Days of neonatal admission to NICU
Time frame: through study completion, an average of 2 months
Metabolic acidosis
Time frame: through study completion, an average of 2 months
Need of maternal corticosteroids
Time frame: through study completion, an average of 2 months
Maternal NT-proBNP levels
Time frame: through study completion, an average of 2 months
Maternal satisfaction measured by the Generic Short Patient Experiences Questionnaire (GS-PEQ)
Time frame: through study completion, an average of 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention arm: expectant management if sFlt-1/PlGF<38 in people with Preeclampsia, run by Hospital Universitari Vall d'Hebron Research Institute at 23 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erika Bonacina, MD, PhD (003493 489 30 00, erika.bonacina@vallhebron.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite maternal outcome (time frame: through study completion, an average of 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.