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NOPE37: Angiogenic Factors fo...

NOPE37: Angiogenic Factors for Managing Term Preeclampsia

NCT ID: NCT07193680

Last Updated: 2025-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

Total Enrollment

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-04

Study Completion Date

2028-04-30

Brief Summary

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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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Detailed Description

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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)

Conditions

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Preeclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Standard care: elective delivery at 37 weeks of gestation

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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

Intervention Type OTHER

Standard care: elective delivery at 37 weeks of gestation

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers