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

Completed

• Conditions: Preeclampsia

• Registration Number: NCT01042210
• Lead Sponsor: Masaryk University

Brief Summary

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.

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 Timeline

• Study Start: 2005-01
• Primary Completion: 2006-03
• Study Completion: 2006-12
• Status Verified: 2009-11
• Study First Submitted: 2010-01-04
• Study First Submitted QC: 2010-01-04
• Last Update Submitted: 2010-01-04
• Study First Posted: 2010-01-05
• Last Update Posted: 2010-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
birth weight of the newborn	immediately postpartum
maternal weight gain during pregnancy	using postpartum and peripartum data
maternal preconceptional BMI	anamnestic information

Trial Locations

Locations (1)

Masaryk university affiliated hospital, Clinic of Obstetrics and Gynecology; 🇨🇿 Brno, Moravia, Czech Republic