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Routine Ultrasound Screening in the Third Trimester (RECRET)

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ClinicalTrials.gov Identifier: NCT01594463
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Study Description
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Brief Summary:
Late intrauterine growth restriction is infrequently diagnosed with an overall sensitivity of 40 % in low-risk pregnancies. In addition, late intrauterine growth restriction may be associated with intrauterine death and poor neonatal outcomes i.e. birth asphyxia and hospitalization in intensive care unit. The investigators hypothesis that a later third trimester routine ultrasound may be more accurate to diagnose late intrauterine growth restriction.

Condition or disease Intervention/treatment Phase
Fetal Growth Retardation High-Risk Pregnancy Other: ultrasound examination Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3760 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Third Trimester Routine Ultrasound in Low-risk Pregnancies : Comparison of Two Timing Periods Procedure for Screening Intrauterine Growth Restriction
Study Start Date : May 2012
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: late ultrasound examination
late examination between 34+1 weeks to 35+6 weeks.
 Other: ultrasound examination
ultrasound examination between 34+1 weeks to 35+6 weeks
Experimental: early ultrasound examination
early examination between 30+1 weeks to 31+6 weeks
 Other: ultrasound examination
ultrasound examination between week 30+1 weeks to 31+6 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Number of small for gestational age infant screened by a routine ultrasound in the third trimester (sensitivity). [ Time Frame: At birth ]
    SGA infant and intrauterine growth restriction are defined using a threshold below the tenth percentile for customized birth weight or customized estimated birth weight.


Secondary Outcome Measures :
  1. Number of neonate with a customized birth weight upper the tenth percentile adequately screened by a routine ultrasound in the third trimester (specificity). [ Time Frame: At birth ]
  2. Number of prenatal consultations, ultrasound scans performed, maternal hospitalization, labor induction, and caesarean section induced by the third trimester routine ultrasound [ Time Frame: After the delivery ]
  3. Maternal complications and neonatal outcomes. [ Time Frame: In the postpartum period ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Accurate gestational dating using crown-rump length at 11-14 weeks
  • Singleton pregnancy
  • Primiparity
  • Normal First trimester (11-14 weeks) and second trimester (20-25 weeks) scans
  • Maternal age > 18 years
  • No maternal opposition for the study

Exclusion Criteria:

  • Maternal diseases i.e. chronic renal disease, hypertension, diabetes, collagen vascular disease, antiphospholipid syndrome
  • Pregnancies with congenital anomalies or foetal growth restriction diagnosed before 30 weeks of gestation
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): NCT01594463


Locations
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France
Rouen University Hospital
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: Eric VERSPYCK, Pr Rouen University Hospital
More Information
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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01594463    
Other Study ID Numbers: 2010/090/HP
First Posted: May 9, 2012    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Keywords provided by University Hospital, Rouen:
Intrauterine growth restriction
Screening
Ultrasound
Perinatal morbidity
Maternal complications
Additional relevant MeSH terms:
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Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes