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

January 4, 2010
January 4, 2010
January 2005
March 2006   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Agouti-related Peptide (AgRP) in Healthy Mothers and Mothers With Preeclampsia and Their Offspring
Genotype-phenotype Associations of Agouti-related Peptide (AgRP) in Postpartum Period in Preeclamptic and Non-preeclamptic Women and Their Offspring

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

whole blood, umbilical blood

Probability Sample

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.

Preeclampsia
Not Provided
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
December 2006
March 2006   (final data collection date for primary outcome measure)

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
Female
18 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
NCT01042210
MU-JBV-PPM1
No
prof. MUDr. Anna Vašků, CSc., Head of the department of pathological physiology, Department of pathological physiology, Faculty of Medicine, Masaryk university, Brno
Masaryk University
Not Provided
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
Masaryk University
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP