Consequences of Antiangiogenic Factors Involved in Preeclampsia on Intra-uterine Growth Restricted Preterm Newborn (ANGIODYS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01648855
First received: July 20, 2012
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

Preeclampsia complicates about 2-7% of pregnancies and is a major contributor to maternal and neonatal morbidity and mortality worldwide. Imbalance between circulating angiogenic and antiangiogenic factors has emerged as a potential key pathway in the pathophysiology of preeclampsia. Patients with preeclampsia have a higher circulating concentration of antiangiogenic factors (ie, soluble vascular endothelial growth factor receptor-1 [sVEGFR- 1], also called soluble fms-like tyrosine kinase 1 [sFlt1]) and soluble endoglin (sEng)] and a lower maternal circulating concentration of free angiogenic factors (ie, vascular endothelial growth factor [VEGF] and placental growth factor [PlGF]) than patients with a normal pregnancy. Bronchopulmonary dysplasia is the main respiratory sequelae of preterm birth. Its rate increased in preterm infants born from mother with preeclampsia. Recent studies showed that bronchopulmonary dysplasia is consistently accompanied by a reduction in the number of small arteries and on abnormal distribution of vessels within the distal lungs. This is associated with reduced lung VEGF expression. The main objective of this population-based study, ie in intra uterine growth restricted preterm babies born before 30 weeks of gestational age, was to examine whether levels of sFlt1 at birth in maternal and umbilical cord blood and in the amniotic fluid is associated with an increased risk of BPD.


Condition Intervention
Preterm Birth
Intra-uterine Growth Restriction
Maternal Preeclampsia
Bronchopulmonary Dysplasia
Other: Biological samples

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Consequences of Circulating Antiangiogenic Factors Involved in Preeclampsia on Intra-uterine Growth Restricted Preterm Newborn

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Levels of sFlt1 (tyrosine kinase 1) at birth and the risk of bronchopulmonary dysplasia [ Time Frame: at 36 weeks of gestational age ] [ Designated as safety issue: No ]
    The main objective of this population-based study, ie in 24 intra uterine growth restricted preterm babies born before 30 weeks of gestational age from mother with preeclampsia, was to examine whether levels of sFlt1 at birth in maternal and umbilical cord blood and in the amniotic fluid is associated with an increased risk of BPD at 36 weeks of gestational age.


Secondary Outcome Measures:
  • Levels of angiogenic and antiangiogenic factors at birth and the complications of preterm birth [ Time Frame: at 36 weeks of gestational age ] [ Designated as safety issue: No ]
    The second objectives are to correlate the levels of angiogenic and antiangiogenic factors at birth, in maternal blood, cord blood and amniotic fluid, and the main complications of preterm birth, ie, necrotizing enterocolitis, intra-ventricular hemorrhage, periventricular leukomalacia or infection before 36 weeks of gestational age.


Estimated Enrollment: 24
Study Start Date: June 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Preterm babies
Intra uterine growth restricted preterm babies born before 30 weeks of gestational age from mother with preeclampsia
Other: Biological samples
To measure the levels of sFlt1, angiogenic and antiangiogenic factors at birth in maternal blood, umbilical cord blood and in the amniotic fluid

Detailed Description:

Preeclampsia complicates about 2-7% of pregnancies and is a major contributor to maternal and neonatal morbidity and mortality worldwide. Preeclampsia is the main cause of intra-uterine growth restriction and could lead to a preterm delivery for fetal or maternal indication. Imbalance between circulating angiogenic and antiangiogenic factors has emerged as a potential key pathway in the pathophysiology of preeclampsia. Patients with preeclampsia have a higher circulating concentration of antiangiogenic factors (ie, soluble vascular endothelial growth factor receptor-1 [sVEGFR- 1], also called soluble fms-like tyrosine kinase 1 [sFlt1]) and soluble endoglin (sEng)] and a lower maternal circulating concentration of free angiogenic factors (ie, vascular endothelial growth factor [VEGF] and placental growth factor [PlGF]) than patients with a normal pregnancy.

Bronchopulmonary dysplasia is the main respiratory sequelae of preterm birth. Its rate increased in preterm infants born from mother with preeclampsia. Recent studies showed that bronchopulmonary dysplasia is consistently accompanied by a reduction in the number of small arteries and on abnormal distribution of vessels within the distal lungs. This is associated with reduced lung VEGF expression. Infants with maternal preeclampsia had higher cord blood sFlt-1 but lower PlGF and VEGF circulating levels. There was a significantly positive relationship between birth weight and cord blood sFlt-1 levels, witness of consequences of these antiangiogenic factors on fetuses. However, no study to date has shown a correlation between the level of angiogenic and antiangiogenic factors and the main complications of preterm birth.

The main objective of this population-based study, ie in 24 intra uterine growth restricted preterm babies born before 30 weeks of gestational age from mother with preeclampsia, was to examine whether levels of sFlt1 at birth in maternal and umbilical cord blood and in the amniotic fluid is associated with an increased risk of BPD at 36 weeks of gestational age. The second objectives are to explore the link between the levels of angiogenic and antiangiogenic factors and the main complications of preterm birth, ie, necrotizing enterocolitis, intra-ventricular hemorrhage, periventricular leukomalacia or infection.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Intra uterine growth restricted preterm babies born before 30 weeks of gestational age from mother with preeclampsia

Criteria

Inclusion Criteria:

  • Maternal preeclampsia
  • Intra uterine growth restriction
  • Preterm birth before 30 weeks of gestational age

Exclusion Criteria:

  • Congenital malformation
  • Eutrophic fetus
  • Chorioamnionitis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01648855

Contacts
Contact: Elodie ZANA-TAIEB, MD +33 1 58 41 20 95 elodiezana@gmail.com
Contact: Laurence LECOMTE, MD, PhD ++33171196494 laurence.lecomte@nck.aphp.fr

Locations
France
Cochin Hospital Recruiting
Paris, France, 75014
Contact: Elodie ZANA-TAIEB, MD    ++33 1 58 41 20 95    elodiezana@gmail.com   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Elodie ZANA-TAIEB, MD Cochin Hospital, Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01648855     History of Changes
Other Study ID Numbers: NI 11030
Study First Received: July 20, 2012
Last Updated: June 25, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Circulating antiangiogenic factors
Preeclampsia
Developing lung
Bronchopulmonary dysplasia

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Fetal Growth Retardation
Pre-Eclampsia
Premature Birth
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes
Hypertension, Pregnancy-Induced
Obstetric Labor, Premature
Obstetric Labor Complications
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014