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

January 4, 2010 updated by: Masaryk University

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
    • Moravia
      • Brno, Moravia, Czech Republic, 625 00
        • Masaryk university affiliated hospital, Clinic of Obstetrics and Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
plasma/serum level of agouti/related peptide in peripheral blood in postpartum mother
Time Frame: 2-4 hours postpartum
2-4 hours postpartum
Plasma level of agouti-related peptide in umbilical cord blood from the newborn
Time Frame: immediately postpartum
immediately postpartum

Secondary Outcome Measures

Outcome Measure
Time Frame
maternal weight gain during pregnancy
Time Frame: using postpartum and peripartum data
using postpartum and peripartum data
birth weight of the newborn
Time Frame: immediately postpartum
immediately postpartum
maternal preconceptional BMI
Time Frame: anamnestic information
anamnestic information

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

January 4, 2010

First Submitted That Met QC Criteria

January 4, 2010

First Posted (Estimate)

January 5, 2010

Study Record Updates

Last Update Posted (Estimate)

January 5, 2010

Last Update Submitted That Met QC Criteria

January 4, 2010

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MU-JBV-PPM1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Preeclampsia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe