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

NCT01648855 | Completed

• 1 other identifier: NI11030
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preterm Birth; Intra-uterine Growth Restriction; Maternal Preeclampsia; Bronchopulmonary Dysplasia

Keywords

Circulating antiangiogenic factors; Preeclampsia; Developing lung; Bronchopulmonary dysplasia

Outcome Measures

Primary Outcomes (1)

• Levels of sFlt1 (tyrosine kinase 1) at birth and the risk of bronchopulmonary dysplasia

  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.

  at 36 weeks of gestational age

Secondary Outcomes (1)

• Levels of angiogenic and antiangiogenic factors at birth and the complications of preterm birth

  at 36 weeks of gestational age

Study Arms (1)

Preterm babies

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

Other: Biological samples

Interventions

Biological samples OTHER

To measure the levels of sFlt1, angiogenic and antiangiogenic factors at birth in maternal blood, umbilical cord blood and in the amniotic fluid

Preterm babies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Congenital malformation
• Eutrophic fetus
• Chorioamnionitis

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Cochin Hospital

Paris, 75014, France

Location

Related Publications (1)

• Torchin H, Combarel D, Aubelle MS, Lopez C, Dubray L, El Ayoubi M, Tsatsaris V, Jarreau PH, Guibourdenche J, Zana-Taieb E. Association of serum angiogenic factors with bronchopulmonary dysplasia. The ANGIODYS cohort study. Pregnancy Hypertens. 2019 Oct;18:82-87. doi: 10.1016/j.preghy.2019.09.015. Epub 2019 Sep 29.

  PMID: 31577982 RESULT

MeSH Terms

Conditions

Premature Birth; Bronchopulmonary Dysplasia; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypertension, Pregnancy-Induced

Study Officials

• Elodie ZANA-TAIEB, MD

  Hôpital Cochin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2012
• First Posted: July 24, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: March 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)