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

Pregnancy; Pre-eclampsia, Mild Clinical Trial

— MAP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02373839
• Other study ID #: CEIC 2013/8820
• Status: Recruiting
• Phase: N/A
• First received: January 17, 2014
• Last updated: February 9, 2018
• Start date: June 2014
• Est. completion date: December 2019

Study information

• Verified date: February 2018
• Source: Fetal Medicine Research Center, Spain
• Contact: Estefania Callado
• Email: ecallado[@]clinic.ub.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia
• Pregnancy; Pre-eclampsia, Mild

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Clinic de Barcelona - Maternitat (BCNatal)	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fetal Medicine Research Center, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Composite of neonatal morbidity	Verma A J Epidemiol Communitary Health 2005 Score	2 weeks
Secondary	maternal risk at induction	according to PIERs score	1 day
Secondary	Average length of maternal hospital stay		90 days
Secondary	Length of neonatal hospital stay.		90 days
Secondary	Length of maternal hospital stay		90 days