NOPE37: Angiogenic Factors for Managing Term Preeclampsia

Vall d'Hebron University Hospital (HUVH)

Status: Enrolling

Conditions: Preeclampsia

Treatments: Other: Intervention arm: expectant management if sFlt-1/PlGF<38; Other: Standard care: elective delivery at 37 weeks of gestation

Study type: Interventional

Funder types: Other

Identifiers

NCT07193680

PR(AMI)392-2023

Details and patient eligibility

About

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.

Full 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):

  1. preeclampsia with severe features according to ACOG criteria
  2. decreased fetal movements
  3. absent or reversed diastolic flow in the umbilical artery
  4. non-reassuring CTG
  5. biophysical profile score ≤6
  6. oligohydramnios (largest vertical pocket <2 cm)

Enrollment: 750 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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750 participants in 2 patient groups

Standard care: elective delivery at 37 weeks of gestation

Active Comparator group

Description:

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.

Treatment:

Other: Standard care: elective delivery at 37 weeks of gestation

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

Experimental group

Description:

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.

Treatment:

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