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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02373839
Acronym
MAP
Enrollment
300
Registered
2015-02-27
Start date
2014-06-30
Completion date
2019-12-31
Last updated
2018-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy; Pre-eclampsia, Mild

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.

Interventions

OTHERMeasurement 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

Sponsors

Fetal Medicine Research Center, Spain
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* \> or = 18 years * pregnant women with non-severe preeclampsia * gestational age between 34 and 36.5 weeks

Exclusion criteria

* No

Design outcomes

Primary

MeasureTime frameDescription
composite of maternal complicationsgestational age between 34 and 36.5 weeksMaternal complications as HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), pulmonary oedema, severe hypertension, eclampsia, thromboembolic disease...
Composite of neonatal morbidity2 weeksVerma A J Epidemiol Communitary Health 2005 Score

Secondary

MeasureTime frameDescription
maternal risk at induction1 dayaccording to PIERs score
Average length of maternal hospital stay90 days
Length of neonatal hospital stay.90 days
Length of maternal hospital stay90 days

Countries

Spain

Contacts

Primary ContactEstefania Callado
ecallado@clinic.ub.es

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026