Intra Uterine Growth Restriction (IUGR)

March 12, 2019 updated by: Hospices Civils de Lyon

Intra Uterine Growth Restriction. Minimum Required Evidence-based Care and Neonatal Prognosis: Impact of Healthcare Pathways

Intrauterine growth restriction (IUGR) is associated with an increase in perinatal mortality and morbidity, as well as longer-term neurological, cognitive, cardiovascular and endocrine complications. In Europe, about 400,000 pregnancies per year are complicated by IUGR. However, antenatal diagnosis seems insufficient in clinical practice, making it impossible to recognize up to 75% of foetuses with IUGR. At a time when the use of good clinical practice has demonstrated a significant improvement in neonatal survival without severe morbidity, foetuses with IUGR are less likely to receive optimal care. Our hypothesis is that the rate of IUGR diagnosed underestimates the rate of actual IUGR.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

31052

Contacts and Locations

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

Study Contact

Study Locations

  • France
      • Bron, France
        • Recruiting
        • Hôpital Femme Mère Enfant
        • Contact:
          • Muriel DORET, Prof.
        • Principal Investigator:
          • Muriel Doret, Prof.

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All birth more than 24 + 0 weeks of amenorrhea at the maternity ward of the hospital Femme-Mère-Enfant from 1st of january 2011 to 31 december 2017.

Description

Inclusion Criteria:

  • All birth more than 24 + 0 weeks of amenorrhea at the maternity ward of the hospital Femme-Mère-Enfant
  • from 1st of january 2011 to 31 december 2017.

Exclusion Criteria:

  • Infants born out of the hospital and secondarily hospitalized in the hospital Femme-Mère-Enfant .
  • Multiple pregnancies,
  • children with congenital fetal anomalies
  • pregnancies without first trimester ultrasound (to date the pregnancy)

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HFME births.
All birth more than 24 + 0 weeks of amenorrhea at the maternity ward of the hospital Femme-Mère-Enfant from 1st of january 2011 to 31 december 2017.
Other: Intrauterine growth restriction (IUGR)
Collection of number of patient's diagnosed with IUGR as defined in accordance with the consensus-based definition for early and late IUGR : birthweight < 3rd centile using French AUDIPOG curves adjusted for term and sex or estimated fetal weight < 10th centile combined with umbilical artery pulsatility index > 95th centile or breakage of growth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients diagnosed with Intrauterine growth restriction
Time Frame: Between 2011 and 2017
IUGR was defined in accordance with the consensus-based definition for early and late IUGR : birthweight < 3rd centile using French AUDIPOG curves adjusted for term and sex or estimated fetal weight < 10th centile combined with umbilical artery pulsatility index > 95th centile or breakage of growth.
Between 2011 and 2017

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Muriel DORET, Prof., Hospices Civils de Lyon

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 (Actual)

September 1, 2018

Primary Completion (Anticipated)

April 1, 2019

Study Completion (Anticipated)

April 1, 2019

Study Registration Dates

First Submitted

March 4, 2019

First Submitted That Met QC Criteria

March 6, 2019

First Posted (Actual)

March 7, 2019

Study Record Updates

Last Update Posted (Actual)

March 13, 2019

Last Update Submitted That Met QC Criteria

March 12, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IUGR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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