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NCT Number: NCT07193680

NOPE37: Angiogenic Factors for Managing Term Preeclampsia

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.

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Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Dexeus, Barcelona, BARCELONA, Spain

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Oligohydramnios
  • Refusal to provide informed consent
  • Fetal malformation
  • Placental abruption
  • Antiphospholipid antibody syndrome

Treatment and study plan

Intervention arm: expectant management if sFlt-1/PlGF<38

Other

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 gestation

Other

In the control arm, standard care for preeclampsia without severe features will be followed: elective delivery at ≥37 weeks of gestation.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Neonatal morbidity

    Time frame: through study completion, an average of 2 months

    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).

  2. Method of delivery

    Time frame: through study completion, an average of 2 months

    Method of delivery, onset of labor, operative vaginal delivery for fetal distress, cesarean section for fetal distress.

  3. Maternal admission to ICU

    Time frame: through study completion, an average of 2 months

    Maternal admission to ICU (yes/no)

  4. Days of maternal admission to ICU

    Time frame: through study completion, an average of 2 months

    Duration of maternal admission to ICU (days)

  5. Gestational age at delivery

    Time frame: through study completion, an average of 2 months

    Gestational age at delivery (weeks and days)

  6. Birthweight

    Time frame: through study completion, an average of 2 months

    Birthweight in grams

  7. Birthweight percentile

    Time frame: through study completion, an average of 2 months

    Birthweight percentile (%) according to local reference charts

  8. Prematurity

    Time frame: through study completion, an average of 2 months

    Prematurity (delivery <37 weeks of gestation), yes/no

  9. Days of neonatal admission to NICU

    Time frame: through study completion, an average of 2 months

    duration of neonatal admission to NICU (days)

  10. Metabolic acidosis

    Time frame: through study completion, an average of 2 months

    Umbilical artery pH <7.10 and base excess <-12 mmol/L (yes/no)

  11. Need of maternal corticosteroids

    Time frame: through study completion, an average of 2 months

    Need of maternal corticosteroids (yes/no)

  12. Maternal NT-proBNP levels

    Time frame: through study completion, an average of 2 months

    Maternal NT-proBNP levels (pg/mL)

  13. Maternal satisfaction measured by the Generic Short Patient Experiences Questionnaire (GS-PEQ)

    Time frame: through study completion, an average of 2 months

    Ten-item measure scored 1-5 per item (total range 10-50; higher scores = better patient experiences).

Study contacts

Contact information is provided by the study sponsor or research team.

Erika Bonacina, MD, PhD

CONTACT

[email protected]

003493 489 30 00

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

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

Acronym: NOPE37

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 26, 2025
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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