NCT00412230

Brief Summary

The purpose of this study is to determine whether insulin resistance might affect the pathogenesis of hypertensive disorders in pregnancy since midtrimester. Furthermore, markers of vascular and placental injuries, of oxidative stress and inflammation will be evaluated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 18, 2006

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

February 18, 2009

Status Verified

February 1, 2009

First QC Date

December 15, 2006

Last Update Submit

February 17, 2009

Conditions

Hypertension in PregnancyDiabetes Mellitus in Pregnancy

Keywords

Pre-eclampsiaGestational diabetesInsulin resistancehypertension in pregnancy

Study Arms (2)

no treatment

2

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pregnant outpatients

You may qualify if:

  • PCOS, BMI\>/=30
  • previous pregnancy affected by hypertension or gestational diabetes
  • thrombophilia
  • Type I or II diabetes mellitus
  • autoimmune diseases
  • twin pregnancy
  • renal diseases
  • previous pre-eclampsia in relatives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Messina, 98121, Italy

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-InducedDiabetes, GestationalPre-EclampsiaInsulin Resistance

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Rosario D'Anna, Associate Professor

    University of Messina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 15, 2006

First Posted

December 18, 2006

Study Start

October 1, 2006

Study Completion

June 1, 2008

Last Updated

February 18, 2009

Record last verified: 2009-02

Locations

IT(1)