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

Study Overview
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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.

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.

Official Title
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Role of Placental Growth Factor (PlGF) in the Management of Non-Severe Preeclampsia, a Randomized Study

Conditions
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Pregnancy; Pre-eclampsia, Mild

Intervention / Treatment
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* Other: Measurement of PlGF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > or = 18 years pregnant women with non-severe preeclampsia gestational age between 34 and 36.5 weeks Exclusion Criteria: No exclusion criteria are defined (intention-to-treat analysis)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PlGF measurement<br>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. | Other: Measurement of PlGF<br>* 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<br>|
| No Intervention: Controls<br>induction of labour at 37 weeks of gestation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite of maternal complications | Maternal complications as HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), pulmonary oedema, severe hypertension, eclampsia, thromboembolic disease... | gestational age between 34 and 36.5 weeks | 
| Composite of neonatal morbidity | Verma A J Epidemiol Communitary Health 2005 Score | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal risk at induction | according to PIERs score | 1 day | 
| Average length of maternal hospital stay |  | 90 days | 
| Length of neonatal hospital stay. |  | 90 days | 
| Length of maternal hospital stay |  | 90 days |