Clinical trial NCT02373839: Role of Placental Growth Factor (PlGF) in the Management of Non-Severe Preeclampsia
Official title: Role of Placental Growth Factor (PlGF) in the Management of Non-Severe Preeclampsia, a Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy; Pre-eclampsia, Mild
Lead sponsor: Fetal Medicine Research Center, Spain
Sponsor class: OTHER
First posted: 2015-02-27
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: composite of maternal complications
timeFrame: gestational age between 34 and 36.5 weeks
measure: Composite of neonatal morbidity
timeFrame: 2 weeks
Secondary outcomes:
measure: maternal risk at induction
timeFrame: 1 day
measure: Average length of maternal hospital stay
timeFrame: 90 days
measure: Length of neonatal hospital stay.
timeFrame: 90 days
measure: Length of maternal hospital stay
timeFrame: 90 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona - Maternitat (BCNatal)
Study officials:
References:
citation: Peguero A, Herraiz I, Perales A, Melchor JC, Melchor I, Marcos B, Villalain C, Martinez-Portilla R, Mazarico E, Meler E, Hernandez S, Matas I, Del Rio M, Galindo A, Figueras F. Placental growth factor testing in the management of late preterm preeclampsia without severe features: a multicenter, randomized, controlled trial. Am J Obstet Gynecol. 2021 Sep;225(3):308.e1-308.e14. doi: 10.1016/j.ajog.2021.03.044. Epub 2021 Apr 3.