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Routine Ultrasound Screening in the Third Trimester (RECRET)

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Rouen Identifier:
First received: April 27, 2012
Last updated: May 10, 2016
Last verified: May 2016
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 Intervention
Fetal Growth Retardation
High-Risk Pregnancy
Other: ultrasound examination

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • 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:
  • 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 ]
  • 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 ]
  • Maternal complications and neonatal outcomes. [ Time Frame: In the postpartum period ]

Enrollment: 3760
Study Start Date: May 2012
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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
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Please refer to this study by its identifier: NCT01594463

Rouen University Hospital
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Principal Investigator: Eric VERSPYCK, Pr Rouen University Hospital
  More Information

Responsible Party: University Hospital, Rouen Identifier: NCT01594463     History of Changes
Other Study ID Numbers: 2010/090/HP
Study First Received: April 27, 2012
Last Updated: May 10, 2016

Keywords provided by University Hospital, Rouen:
Intrauterine growth restriction
Perinatal morbidity
Maternal complications

Additional relevant MeSH terms:
Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes processed this record on May 25, 2017