Intra Uterine Growth Restriction
IUGR
1 other identifier
observational
31,052
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2018
CompletedFirst Submitted
Initial submission to the registry
March 4, 2019
CompletedFirst Posted
Study publicly available on registry
March 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedMarch 13, 2019
March 1, 2019
7 months
March 4, 2019
March 12, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
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.
Interventions
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.
Eligibility 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.
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Femme Mère Enfant
Bron, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Muriel DORET, Prof.
Hospices Civils de Lyon
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2019
First Posted
March 7, 2019
Study Start
September 1, 2018
Primary Completion
April 1, 2019
Study Completion
April 1, 2019
Last Updated
March 13, 2019
Record last verified: 2019-03