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

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ClinicalTrials.gov Identifier: NCT02373839
Recruitment Status : Recruiting
First Posted : February 27, 2015
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Fetal Medicine Research Center, Spain

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.


Condition or disease Intervention/treatment Phase
Pregnancy; Pre-eclampsia, Mild Other: Measurement of PlGF Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Role of Placental Growth Factor (PlGF) in the Management of Non-Severe Preeclampsia, a Randomized Study
Study Start Date : June 2014
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. composite of maternal complications [ Time Frame: gestational age between 34 and 36.5 weeks ]
    Maternal complications as HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), pulmonary oedema, severe hypertension, eclampsia, thromboembolic disease...

  2. Composite of neonatal morbidity [ Time Frame: 2 weeks ]
    Verma A J Epidemiol Communitary Health 2005 Score


Secondary Outcome Measures :
  1. maternal risk at induction [ Time Frame: 1 day ]
    according to PIERs score

  2. Average length of maternal hospital stay [ Time Frame: 90 days ]
  3. Length of neonatal hospital stay. [ Time Frame: 90 days ]
  4. Length of maternal hospital stay [ Time Frame: 90 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373839


Contacts
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Contact: Estefania Callado ecallado@clinic.ub.es

Locations
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Spain
Hospital Clinic de Barcelona - Maternitat (BCNatal) Recruiting
Barcelona, Spain, 08036
Contact: Estefania Callado       ecallado@clinic.ub.es   
Principal Investigator: Francesc Figueras         
Principal Investigator: Anna Peguero         
Principal Investigator: Sandra Hernandez         
Sponsors and Collaborators
Fetal Medicine Research Center, Spain

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Responsible Party: Fetal Medicine Research Center, Spain
ClinicalTrials.gov Identifier: NCT02373839     History of Changes
Other Study ID Numbers: CEIC 2013/8820
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
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Pre-Eclampsia
Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action