Role of Placental Growth Factor (PlGF) in the Management of Non-Severe Preeclampsia (MAP)
Primary Purpose
Pregnancy; Pre-eclampsia, Mild
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Measurement of PlGF
Sponsored by
About this trial
This is an interventional prevention trial for Pregnancy; Pre-eclampsia, Mild
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)
Sites / Locations
- Hospital Clinic de Barcelona - Maternitat (BCNatal)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
PlGF measurement
Controls
Arm Description
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.
induction of labour at 37 weeks of gestation.
Outcomes
Primary Outcome Measures
composite of maternal complications
Maternal complications as HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), pulmonary oedema, severe hypertension, eclampsia, thromboembolic disease...
Composite of neonatal morbidity
Verma A J Epidemiol Communitary Health 2005 Score
Secondary Outcome Measures
maternal risk at induction
according to PIERs score
Average length of maternal hospital stay
Length of neonatal hospital stay.
Length of maternal hospital stay
Full Information
NCT ID
NCT02373839
First Posted
January 17, 2014
Last Updated
February 9, 2018
Sponsor
Fetal Medicine Research Center, Spain
1. Study Identification
Unique Protocol Identification Number
NCT02373839
Brief Title
Role of Placental Growth Factor (PlGF) in the Management of Non-Severe Preeclampsia
Acronym
MAP
Official Title
Role of Placental Growth Factor (PlGF) in the Management of Non-Severe Preeclampsia, a Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fetal Medicine Research Center, Spain
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy; Pre-eclampsia, Mild
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PlGF measurement
Arm Type
Other
Arm Description
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.
Arm Title
Controls
Arm Type
No Intervention
Arm Description
induction of labour at 37 weeks of gestation.
Intervention Type
Other
Intervention Name(s)
Measurement of PlGF
Intervention Description
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
Primary Outcome Measure Information:
Title
composite of maternal complications
Description
Maternal complications as HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), pulmonary oedema, severe hypertension, eclampsia, thromboembolic disease...
Time Frame
gestational age between 34 and 36.5 weeks
Title
Composite of neonatal morbidity
Description
Verma A J Epidemiol Communitary Health 2005 Score
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
maternal risk at induction
Description
according to PIERs score
Time Frame
1 day
Title
Average length of maternal hospital stay
Time Frame
90 days
Title
Length of neonatal hospital stay.
Time Frame
90 days
Title
Length of maternal hospital stay
Time Frame
90 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Estefania Callado
Email
ecallado@clinic.ub.es
Facility Information:
Facility Name
Hospital Clinic de Barcelona - Maternitat (BCNatal)
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Estefania Callado
Email
ecallado@clinic.ub.es
First Name & Middle Initial & Last Name & Degree
Francesc Figueras
First Name & Middle Initial & Last Name & Degree
Anna Peguero
First Name & Middle Initial & Last Name & Degree
Sandra Hernandez
12. IPD Sharing Statement
Citations:
PubMed Identifier
33823150
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.
Results Reference
derived
Learn more about this trial
Role of Placental Growth Factor (PlGF) in the Management of Non-Severe Preeclampsia
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