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Clinical Trials/NCT03866863
NCT03866863
Unknown
Not Applicable

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

Hospices Civils de Lyon1 site in 1 country31,052 target enrollmentSeptember 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intrauterine Growth Restriction
Sponsor
Hospices Civils de Lyon
Enrollment
31052
Locations
1
Primary Endpoint
Number of patients diagnosed with Intrauterine growth restriction
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2018
End Date
April 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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.

Study Sites (1)

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