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Oxidative Stress and Endothelial Function in Pregnancy Complications (ENDOPREG)

This study is currently recruiting participants.
Verified October 2016 by Prof Yves Jacquemyn, Universiteit Antwerpen
Sponsor:
ClinicalTrials.gov Identifier:
NCT02603913
First Posted: November 13, 2015
Last Update Posted: October 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University Hospital, Antwerp
Ziekenhuis Oost-Limburg
Maastricht University Medical Center
Erasmus Medical Center
Information provided by (Responsible Party):
Prof Yves Jacquemyn, Universiteit Antwerpen
  Purpose
Pregnancy complications like pre-eclampsia (PE), pregnancy induced hypertension (PIH), intra-uterine growth restriction (IUGR) and preterm labor (PTL), (i.e. the major part of complications in pregnancy) are related to an impaired endothelial function. Endothelial dysfunction accounts for altered vascular reactivity, activation of the coagulation cascade and loss of vascular integrity. Nitric oxide (NO), a free radical molecule derived from L-Arginine by NOS (Nitric Oxide Synthase), is an endogenous endothelium-derived relaxing factor influencing endothelial function. In the placental circulation, endothelial release of NO dilates the fetal placental vascular bed and thus ensures feto-maternal exchange. The impaired endothelial function in pregnancy complications originates from production of inflammatory and cytotoxic factors by the ischemic placenta and results in oxidative stress and an altered bioavailability of NO. Measurement of endothelial function using peripheral artery tonometry and determination of ROS (reactive oxygen species) and RNS (reactive nitrogen species) using Electron Paramagnetic Resonance (EPR) gives an idea of the oxidative stress that took place and the degree of endothelial dysfunction that occurred during pregnancy.

Condition
Pregnancy Complications Endothelial Dysfunction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oxidative Stress and Endothelial Function in Pregnancy Complications: Development of a New Screening Algorithm

Resource links provided by NLM:


Further study details as provided by Prof Yves Jacquemyn, Universiteit Antwerpen:

Primary Outcome Measures:
  • Oxidative stress. Measurement of nitric oxide and eNOS in placental tissue and superoxide in maternal serum using EPR and western blotting. [ Time Frame: Pregnancy - 6 months postpartum ]

    Single center prospective longitudinal study: To evaluate the oxidative stress profile in normal pregnancies.

    Multicenter matched case-control study: To compare the oxidative stress profile in normal versus complicated pregnancies.



Secondary Outcome Measures:
  • Endothelial function (using Endopat®) [ Time Frame: Pregnancy - 6 months postpartum ]

    Single center prospective longitudinal study: To evaluate endothelial function in normal pregnancies.

    Multicenter matched case-control study: To compare endothelial function in normal versus complicated pregnancies.

    To relate endothelial function (using Endopat ®) to nitric oxide/eNOS/superoxide concentration (using EPR and Western Blotting).


  • Arterial stiffness (Pulse wave velocity, pulse wave analysis using Sphygmocor ®). [ Time Frame: Pregnancy - 6 months postpartum ]

    Single center prospective longitudinal study: To evaluate arterial stiffness in normal pregnancies.

    Multicenter matched case-control study: To compare arterial stiffness in normal versus complicated pregnancies.

    To relate Arterial stiffness (using Sphygmocor ®) to nitric oxide/eNOS/superoxide concentration (using EPR and Western Blotting).


  • Pregnancy outcome [ Time Frame: Pregnancy - 6 months postpartum ]

    Pregnancy outcome will be determined using the diagnostic criteria described in 'groups and interventions'.

    Single center prospective longitudinal study and multicenter matched case-control study.

    To relate oxidative stress profile to pregnancy outcome.


  • Pulsatility index uterine artery (using doppler ultrasound). [ Time Frame: Pregnancy - 6 months postpartum ]
    Single center prospective longitudinal study and multicenter matched case-control study.

  • Mean platelet volume (MPV (fL)) [ Time Frame: Pregnancy - 6 months postpartum ]
    Single center prospective longitudinal study and multicenter matched case-control study.

  • Neutrophil-lymphocyte ratio (NLR) [ Time Frame: Pregnancy - 6 months postpartum ]
    Single center prospective longitudinal study and multicenter matched case-control study.


Biospecimen Retention:   Samples Without DNA
Blood and placenta samples

Estimated Enrollment: 330
Study Start Date: November 2015
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal pregnancy
Normal uncomplicated pregnancy
Pre-eclampsia

Hypertension (>140 mmHg systolic or >90 mmHg diastolic) developing after 20 weeks gestation and the coexistence of one or more of the following new onset conditions:

  1. Proteinuria (>300 mg/day)
  2. Other maternal organ dysfunction

    • renal insufficiency (creatinine >90 μmol/L)
    • liver involvement (elevated transaminases - and/or severe right upper quadrant or epigastric pain)
    • neurological complications (eclampsia, altered mental status, blindness, stroke, hyperreflexia when accompanied by clonus, severe headaches when accompanied by hyperreflexia, persistent visual scotomata)
    • hematological complications (thrombocytopenia, disseminated intravascular coagulation, hemolysis)
  3. Uteroplacental dysfunction
Pregnancy induced hypertension
New onset of hypertension (>140 mmHg systolic or >90 mmHg diastolic) after 20 weeks gestation, without proteinuria, in a previously normotensive woman.
Preterm birth
Babies born alive before 37 weeks of pregnancy are completed.
Intra-uterine growth restriction
Moderate IUGR is an estimated fetal weight and / or abdominal circumference < 10th percentile for its gestational age Severe IUGR is an EFW (estimated fetal weight) and/ or AC (abdominal circumference) < 5th percentile for its gestational age

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients will be included at one of the participating tertiary obstetrical centers (UZA, ZOL, Erasmus MC, MUMC).

They will be included at the beginning of pregnancy in the longitudinal studies. In the case-control study, they will be included at the moment of diagnosis and compared to normotensive controls, matched for maternal and gestational age, parity, smoking behavior, BMI and ethnic group.

Criteria

Inclusion Criteria:

  • Prospective longitudinal study:

    • Pregnant women ≥ 18 years old with a singleton pregnancy
  • Case-control study:

    • Pregnant women ≥ 18 years old with a singleton pregnancy and > 20 weeks of pregnancy.
    • Cases: Pre-eclampsia, PIH, IUGR, Preterm birth (cfr groups)

Exclusion criteria:

  • gestational diabetes
  • multiple pregnancies
  • fetal abnormalities
  • hypercholesterolemia
  • renal disease
  • auto-immune disorders
  • connective tissue disease
  • intake of low-dose aspirin or vitamin C supplements (>500mg/day)
  Contacts and Locations
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): NCT02603913


Contacts
Contact: Yves Jacquemyn, MD PhD 003238213905 yves.jacquemyn@uza.be
Contact: Dominique AM Mannaerts, MD 003238215334 mannaerts.dominique@gmail.com

Locations
Belgium
University Hospital Antwerp Recruiting
Edegem, Antwerp, Belgium, 2650
Contact: Yves Jacquemyn, Phd    +3238215945    yves.jacquemyn@uza.be   
Contact: Dominique Mannaerts, MD    +3238215334    mannaerts.dominique@gmail.com   
Sponsors and Collaborators
Universiteit Antwerpen
University Hospital, Antwerp
Ziekenhuis Oost-Limburg
Maastricht University Medical Center
Erasmus Medical Center
Investigators
Principal Investigator: Dominique AM Mannaerts, MD Universiteit Antwerpen
  More Information

Publications:
Responsible Party: Prof Yves Jacquemyn, Professor, Universiteit Antwerpen
ClinicalTrials.gov Identifier: NCT02603913     History of Changes
Other Study ID Numbers: UZA-Endopreg-2015-1
First Submitted: October 18, 2015
First Posted: November 13, 2015
Last Update Posted: October 31, 2016
Last Verified: October 2016

Keywords provided by Prof Yves Jacquemyn, Universiteit Antwerpen:
Pre-eclampsia
Pregnancy induced hypertension
Preterm birth
Intra-uterine growth restriction
Oxidative stress

Additional relevant MeSH terms:
Pregnancy Complications