Role of Placental Growth Factor (PlGF) in the Management of Non-Severe Preeclampsia

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2019-12-31

Brief Summary

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Preeclampsia is an important disease that develops during pregnancy and it is one of the main contributors to maternal and fetal complications.

The only known definitive treatment is delivery. Although delivery is always appropriate for the mother, it might not be the best for a very premature neonate.

In cases of non-severe preeclampsia there no benefit delaying delivery beyond 37 weeks. It is also well established that before 34 weeks an expectant management confers perinatal benefit with minimum amount of additional maternal risk. There is then an area of uncertainty between 37 and 37 weeks. This is why in this period it is a clinical need to select high risk patients of complications that will benefit from labor induction, and differentiate them from low risk patients that can be manage expectantly until 37 weeks.

Placental growth factor (PlGF) is an angiogenic factor that is lower in pregnant women with preeclampsia and current evidence shows that it as a predictor of adverse pregnancy outcome and requirement of delivery.

Circulating levels of PIGF at 34 weeks could help to identify those women that may benefit from labor induction and those where delivery can be delayed until 37 weeks with low risk for maternal complications.

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Detailed Description

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BACKGROUND

The current definition of pre-eclampsia is a new onset hypertension (\>140/90mmHg) and proteinuria (\>0'3g per 24 hours) after 20 weeks of gestation. Pre-eclampsia affects 3% to 8% of all pregnancies and it is a leading cause of maternal and neonatal morbidity and mortality.

It has been subclassified by clinical severity in severe and non-severe and by gestational age at the diagnosis in early and late onset pre-eclampsia (\>34 weeks of gestation).

Pre-eclampsia is associated with abnormal placentation and uterine angiogenesis. Pregnant women with preeclampsia show lower circulating levels of placental growth factor (PlGF), a proangiogenic factor related to placental angiogenesis, compared with healthy pregnant women. Moreover evidence has been found regarding the role of PlGF as a predictor of adverse pregnancy outcome and requirement of delivery.

The only definitive treatment of the disease is delivery. In patients with non-severe preeclampsia between 34 and 37 weeks there is no consensus regarding the ideal time of delivery.

AIM: The aim of this study is to assess whether circulating levels of PIGF at 34 weeks could help to identify those women that may benefit from labor induction and those where delivery can be delayed until 37 weeks with low risk for maternal complications.

Conditions

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Pregnancy; Pre-eclampsia, Mild

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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PlGF measurement

Determination of PlGF levels. If lower than 100 pg/mL labour will be inducted at the moment of diagnosis. Otherwise standard monitoring will be done with labour induction at 37 weeks.

Group Type OTHER

Measurement of PlGF

Intervention Type OTHER

If lower than 100 pg/mL labour will be inducted at the moment of diagnosis. Otherwise standard monitoring will be done with labour induction at 37 weeks

Controls

induction of labour at 37 weeks of gestation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Measurement of PlGF

If lower than 100 pg/mL labour will be inducted at the moment of diagnosis. Otherwise standard monitoring will be done with labour induction at 37 weeks

Intervention Type OTHER