Agouti-related Peptide (AgRP) in Healthy Mothers and Mothers With Preeclampsia and Their Offspring

This study has been completed.
Sponsor:
Information provided by:
Masaryk University
ClinicalTrials.gov Identifier:
NCT01042210
First received: January 4, 2010
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

The study is focused on the investigation of possible associations between plasma/serum levels of agouti related peptide (AgRP) and its genetic background in healthy women with physiological pregnancy (non-preeclamptic) and women with preeclampsia, in the postpartum period, and in their offspring.


Condition
Preeclampsia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Genotype-phenotype Associations of Agouti-related Peptide (AgRP) in Postpartum Period in Preeclamptic and Non-preeclamptic Women and Their Offspring

Resource links provided by NLM:


Further study details as provided by Masaryk University:

Primary Outcome Measures:
  • plasma/serum level of agouti/related peptide in peripheral blood in postpartum mother [ Time Frame: 2-4 hours postpartum ] [ Designated as safety issue: No ]
  • Plasma level of agouti-related peptide in umbilical cord blood from the newborn [ Time Frame: immediately postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • maternal weight gain during pregnancy [ Time Frame: using postpartum and peripartum data ] [ Designated as safety issue: No ]
  • birth weight of the newborn [ Time Frame: immediately postpartum ] [ Designated as safety issue: No ]
  • maternal preconceptional BMI [ Time Frame: anamnestic information ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood, umbilical blood


Enrollment: 84
Study Start Date: January 2005
Study Completion Date: December 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts
Mothers, preeclampsia
Mothers with preeclampsia diagnosed according to the Guidelines by the Czech Society of obstetrics and gynecology as development of hypertension after the 20th week of pregnancy (systolic blood pressure, ≥140 mmHg; and/or diastolic blood pressure, ≥90 mmHg; measured at rest on two consecutive occasions at least 24 h apart) in previously normotensive women, and the onset of proteinuria (>300 mg of urinary protein/L over 24 h).
Newborns, physiological pregnancy-delivery
The newborns from the physiological pregnancies with spontaneous, uncomplicated delivery.
Newborns, pregnancy with preeclampsia
Newborns from the pregnancies complicated by preeclampsia.
Mothers, Physiological pregnancy-labour
The cohort of non-preeclamptic mothers with physiological, uncomplicated conception, pregnancy and delivery.

Detailed Description:

The study is focused on investigation of possible genotype-phenotype interactions of agouti-related peptide (AgRP) in postpartum non-preeclamptic women and preeclamptic women and in their offspring.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients of the Masaryk university afilliated hospital, Clinic of Obstetrics and Gynecology,hospitalized due to preeclampsia or healthy women with uncomplicated conception, pregnancy and delivery that came to give birth at the Clinic. Along with the mothers, their offspring in included in the study. The study population originated from a static region of the Czech Republic - South Moravia.

Criteria

Inclusion Criteria:

  • For preeclampsia:

    • development of hypertension after the 20th week of pregnancy (systolic blood pressure, ≥140 mmHg; and/or diastolic blood pressure, ≥90 mmHg; measured at rest on two consecutive occasions at least 24 h apart) in previously normotensive women, and the onset of proteinuria (>300 mg of urinary protein/L over 24 h)
    • single-fetus pregnancy
    • age range 18-35 y
    • no preconceptional history of hypertension
  • For mother with physiological pregnancies:

    • uncomplicated
    • spontaneous conception
    • single-fetus pregnancy
    • age range 18-35 y
    • spontaneous uncomplicated delivery
    • no history of preconceptional hypertension

Exclusion Criteria:

  • For preeclampsia:

    • multiple pregnancy
    • preeclampsia superimposed to chronic hypertension preceding pregnancy
    • kidney disease
    • fetal malformations
  • For mothers with physiological pregnancies:

    • in vitro fertilization
    • fetal malformations
    • multiple pregnancy
    • events of bleeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01042210

Locations
Czech Republic
Masaryk university affiliated hospital, Clinic of Obstetrics and Gynecology
Brno, Moravia, Czech Republic, 625 00
Sponsors and Collaborators
Masaryk University
Investigators
Principal Investigator: Julie Bienertova-Vasku, MD.,, Ph.D. Department of Pathological Physiology, Faculty of Medicine, Masaryk University
Study Director: Anna Vasku, prof. Ph.D. Department of Pathological Physiology, Faculty of Medicine, Masaryk University
Study Director: Petr Bienert, Dr. Department of Pathological Physiology, Faculty of Medicine, Masaryk University
  More Information

Publications:
Responsible Party: prof. MUDr. Anna Vašků, CSc., Head of the department of pathological physiology, Department of pathological physiology, Faculty of Medicine, Masaryk university, Brno
ClinicalTrials.gov Identifier: NCT01042210     History of Changes
Other Study ID Numbers: MU-JBV-PPM1
Study First Received: January 4, 2010
Last Updated: January 4, 2010
Health Authority: Czech Republic: Ethics Committee

Keywords provided by Masaryk University:
preeclampsia
agouti-related peptide
intrauterine growth
birth weight
Intrauterine growth restriction due to preeclampsia

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications

ClinicalTrials.gov processed this record on April 17, 2014