Intra Uterine Growth Restriction

Intrauterine Growth Restriction Clinical Trial

— IUGR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03866863
• Other study ID #: IUGR
• Status: Recruiting
• Start date: September 1, 2018
• Est. completion date: April 2019

Study information

• Verified date: March 2019
• Source: Hospices Civils de Lyon
• Contact: Muriel DORET, Prof.
• Phone: 4 27 85 51 70
• Email: muriel.doret-dion[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 31052
• Est. completion date: April 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Intrauterine Growth Restriction

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Femme Mère Enfant	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients diagnosed with Intrauterine growth restriction	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