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Intra Uterine Growth Restriction (IUGR)

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ClinicalTrials.gov Identifier: NCT03866863
Recruitment Status : Unknown
Verified March 2019 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : March 7, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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.

Condition or disease Intervention/treatment
Intrauterine Growth Restriction Other: Intrauterine growth restriction (IUGR)

Study Design
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Study Type : Observational
Estimated Enrollment : 31052 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Intra Uterine Growth Restriction. Minimum Required Evidence-based Care and Neonatal Prognosis: Impact of Healthcare Pathways
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : April 2019
Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03866863


Contacts
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Contact: Muriel DORET, Prof. 4 27 85 51 70 ext 33 muriel.doret-dion@chu-lyon.fr

Locations
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France
Hôpital Femme Mère Enfant Recruiting
Bron, France
Contact: Muriel Doret, Prof.         
Principal Investigator: Muriel Doret, Prof.         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Muriel DORET, Prof. Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03866863    
Other Study ID Numbers: IUGR
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes