NCT02373839

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
9 months until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 12, 2018

Status Verified

February 1, 2018

Enrollment Period

4.4 years

First QC Date

January 17, 2014

Last Update Submit

February 9, 2018

Conditions

Pregnancy; Pre-eclampsia, Mild

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • maternal risk at induction

    1 day

  • Average length of maternal hospital stay

    90 days

  • Length of neonatal hospital stay.

    90 days

  • Length of maternal hospital stay

    90 days

Study Arms (2)

PlGF measurement

OTHER

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

Controls

NO INTERVENTION

induction of labour at 37 weeks of gestation.

Interventions

Measurement of PlGFOTHER

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

PlGF measurement

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic de Barcelona - Maternitat (BCNatal)

Barcelona, 08036, Spain

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33823150DERIVED

MeSH Terms

Conditions

Pre-EclampsiaLymphoma, Follicular

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Estefania Callado

CONTACT

ecallado@clinic.ub.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2014

First Posted

February 27, 2015

Study Start

June 1, 2014

Primary Completion

November 1, 2018

Study Completion

December 1, 2019

Last Updated

February 12, 2018

Record last verified: 2018-02

Locations

ES(1)