Intra Uterine Growth Restriction

• Conditions: Intrauterine Growth Restriction
• Interventions: Other: Intrauterine growth restriction (IUGR)

• Registration Number: NCT03866863
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Status Verified: 2019-03
• Study First Submitted: 2019-03-04
• Study First Submitted QC: 2019-03-06
• Study First Posted: 2019-03-07
• Last Update Submitted: 2019-03-12
• Last Update Posted: 2019-03-13
• Primary Completion: 2019-04-01
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 31052

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.

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HFME births.	Intrauterine growth restriction (IUGR)	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.

Primary Outcome Measures

Name	Time	Method
Number of patients diagnosed with Intrauterine growth restriction	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.

Trial Locations

Locations (1)

Hôpital Femme Mère Enfant; 🇫🇷 Bron, France