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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03866863
Other study ID # IUGR
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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)

Study Design


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
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