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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pregnancy; Pre-eclampsia, Mild
• Intervention / Treatment: Other: Measurement of PlGF

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic de Barcelona - Maternitat (BCNatal)
    • Contact: Estefania Callado; Email: ecallado@clinic.ub.es
    • Principal Investigator: Francesc Figueras
    • Principal Investigator: Anna Peguero
    • Principal Investigator: Sandra Hernandez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Other: 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
No Intervention: Controls; induction of labour at 37 weeks of gestation.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fetal Medicine Research Center, Spain

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: January 17, 2014
• First Submitted That Met QC Criteria: February 22, 2015
• First Posted (Estimate): February 27, 2015

Study Record Updates

• Last Update Posted (Actual): February 12, 2018
• Last Update Submitted That Met QC Criteria: February 9, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: CEIC 2013/8820

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No